Good morning, and welcome, ladies and gentlemen, to the CRISPR Therapeutics Clinical Update conference call. At this time, I would like to inform you that this conference call is being recorded and that all participants are in a listen-only mode.
Edited allogeneic CAR-T program into the clinic in just four years, the first of which we will talk more about today. We could not have accomplished all of this without the.
CRISPR Therapeutics Vice President of Investor Relations and Corporate Communications. Please go ahead.
Good morning, and thank you for joining us as we report results from the CARBON trial, an ongoing phase I study of CTX110, a healthy donor-derived gene-edited allogeneic CAR-T therapy for the treatment of CD19+ B-cell malignancies. We recommend that you access the webcast slides on our website as you listen to this call. This conference call is being recorded and a replay will be available on our website. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy and safety of our product candidates, our research and development plans, regulatory plans, and our plans to present or report additional data. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in the forward-looking statements.
These and other risks are described in our periodic filings made with the SEC, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date. The company disclaims any obligation to update such statements. Joining me this morning are Sam Kulkarni, our Chief Executive Officer, Evelina Marava, our Vice President of Clinical Development, Dr. Joe McGuirk, Professor of Medicine and Division Director of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center and one of the investigators on the study, and Tony Ho, our Head of Research and Development. With that, I'm pleased to turn the call over to Sam Kulkarni, who will make some introductory remarks.
Thank you, Susie. Good morning, and thank you all for joining us today. Earlier this morning, we reported the first clinical results from our phase I CARBON trial of CTX110 for the treatment of B-cell malignancies. We are proud to share this data just a few days after our scientific founder, Dr. Emmanuelle The first company to test the B2M knockout strategy as a means of allowing allogeneic persistence without the need for more toxic preconditioning regimens, Jennifer Doudna. Over the past five years, we have made tremendous progress in building the leading CRISPR company with four clinical programs, over 300 employees, and over $1 billion in cash balance. In 2019, we were the first to demonstrate the power of CRISPR gene editing in patients with rare diseases.
CARBON trial, which is currently open to enrollment globally at seven participating institutions on three continents. CARBON is enrolling adult patients with.
Building beyond CTX001, we have advanced three gene-edited allogeneic CAR-T programs into the clinic in just four years.
Are not eligible. Patients receive three days of lymphodepleting chemotherapy consisting of fludarabine at 30 mg per meter squared and cyclophosphamide at 500 mg per meter squared, followed by CTX110 infusion. Some patients have completed screening in as few as three days, and all patients began LD chemotherapy within a median of two days of enrollment. This timeline is possible because there's no need for apheresis or bridging chemo-
Oncology based on the belief that multiplex gene editing, which CRISPR enables to a greater extent than earlier technologies, will be essential to capturing the full.
Efficacy of escalating doses of CTX110. After a dose of CTX110 is determined, the trial will proceed seamlessly.
Allogeneic CAR-T, in which the T-cells from a healthy donor are used as a starting material instead of a patient's own cells, could overcome many of the
Enrolled in this study, and all have received CTX110. Dose escalation began at 30 million CAR-positive T-cells for Dose Level 1 and escalated in approximately two or three fold increments to the highest dose of 600 million CAR-positive T-cells, which is Dose Level 4. At each-
We believe that over time, allogeneic therapies represent a whole new class of medicines that can become the first line of defense in the fight against cancer. Creating a safe and effective allogeneic CAR-T therapy requires the editing of multiple genes within a T-cell.
Into both Dose Level 3 and Dose Level 4 cohorts simultaneously. 11 patients have had at least 28 days of post-treatment follow-up.
Gene is added to the genome of healthy donor T-cells that are designed to avoid graft versus host disease, target the CAR T-cells to the tumor, and evade a patient's immune system. To our knowledge, we are the first company to test the B2M knockout strategy as a means of allowing allogeneic persistence without the need for more toxic preconditioning regimens. I will now turn the call over to Dr. Evelina Marava, our Vice President of Clinical Development, and Dr. Joe McGuirk, Professor of Medicine at the University of Kansas Medical Center, who will go through a presentation of initial data from the CARBON trial.
Thank you, Sam. Dose escalation of CTX110 is being performed in the CARBON trial, which is currently open to enrollment globally at seven participating institutions on three continents. CARBON is enrolling adult patients with relapsed or refractory large B-cell non-Hodgkin's lymphoma who have failed at least two lines of therapy. Early evidence of dose-dependent responses was seen with CTX110. Efficacy assessment was performed by centralized, independent at 30 mg per meter squared and cyclophosphamide at 500 mg per meter squared, followed by CTX110 infusion. Some patients have completed screening in as few as three days, and all patients began LD chemotherapy within a median of two days of enrollment. This timeline is possible because there's no need for apheresis or bridging chemotherapy on this trial, and CTX110 is available at the site before a patient is enrolled.
The primary objective of CARBON is to evaluate the safety and efficacy of escalating doses of CTX110. After a dose of CTX110 is determined, the trial will proceed seamlessly into a potentially registrational single-arm efficacy expansion cohort. As of September 28th, 2020, 12 patients have been enrolled in this study, and all have received CTX110. Dose escalation began at 30 million CAR-positive T-cells, or Dose Level 1, and escalated in approximately two or three fold increments to the highest dose of 600 million CAR % change in tumor size for patients treated with CTX110 across the four Dose Level s. The color of the bars reflects the dose level at which no DLTs were observed in Dose Level 1, 2, or 3.
After the initial cohort of three patients were treated at Dose Level 3, the encouraging antitumor activity led us to enroll additional patients into both Dose Level 3 and Dose Level 4 cohorts simultaneously. 11 patients for nodal disease, normalization of all nodal disease to 1.5 centimeter or smaller, and a Deauville score of 2 or lower. Additionally, this study continues to enroll currently. This table summarizes the baseline characteristics for patients enrolled in CARBON across the four dose levels. These patient characteristics are consistent with those in other clinical trials evaluating autologous or allogeneic CD19 response and follow-up. Median follow-up time for the 11 patients was 1.8 months. All patients treated at Dose Level 2 or 3 who had a complete, having received at least two lines of therapy, including four patients with prior autologous transplant.
The majority of patients had advanced-stage lymphoma and were refractory to their last line of therapy before entering the study. The median time from last therapy to the start of LD chemotherapy for all 11 and is planned to be redosed at Dose Level 3. The patient at Dose Level 4 that achieved a complete response at month one has subsequently died due to an adverse event after data cut-off and will be discussed in more detail later. This table summarizes the safety data for the 10 patients treated at Dose Level 3 and below that occurred following CTX110 infusion. First, there have been no cases of GvHD despite the high HLA mismatch between CAR-T or commercial CD19-directed CAR-T products. Although Dose Level 1 was determined to be sub-efficacious, complete responses were obtained at dose level emergent adverse events of special interest.
Three patients treated with CTX110 have experienced a total of four events of CRS. Two of these events, two of the four patients had a complete response. To date, all of the objective responses in the study have been complete responses and were seen at the first and grade 2 ICANS occurred in one patient and improved within 24 hours of steroid administration. Two additional treatment emergence in two patients with transformed follicular lymphoma, as well as in patients who are primary refractory and who had relapsed after autologous stem cell transplant for leukemia. In summary, these preliminary data suggest an acceptable safety profile at Dose Level 3 and below, with no events of graft-versus-host disease or grade 3 or higher of CRS or ICANS.
The one patient recently treated at Dose Level 4 with a seven-week shows evidence of decreasing tumor size and that the deeper responses are associated with higher doses of CTX110. The four patients with complete responses had complete resolution of extranodal disease, normalization of all nodal disease to 1.5 cm or smaller, and a Deauville score of two or lower. One of the patients with a complete response achieved complete clearance of 30% lymph who was admitted for febrile neutropenia on day 26, and shortly after, on day 28, began to have short-term memory loss and confusion. The symptoms eventually progressed to significant obtundation that required intubation. The patient underwent several diagnostic procedures, including a lumbar puncture and brain MRI. He was initially treated for ICANS with high-dose steroids and anakinra and intrathecal chemotherapy without any improvement.
He was at dose level 2 who achieved a complete response, with signs of recurrence of disease on imaging approximately 5.75 months after CTX110 screening showed that he was HHV-6 IgG positive, consistent with prior HHV-6 infection. The diagnosis of HHV-6 encephalitis at month 1 has subsequently died due to an adverse event after data cut-off and will be discussed in more detail later. This table summarizes this per milliliter. Subsequently, he began a course of antiviral therapy, which continued for 13 days. However, in view of the patient's status and at the request of [audio distortion], despite the high HLA mismatch between CAR T donors and patients. Second, no infusion reactions to either lymphodepleting chemotherapy or CTX110 have occurred. Focusing on treatment-emergent adverse events of special interest, three patients treated with CTX110 have experienced a total of four events of CRS.
Two of these events were Grade 1 CRS per ASTCT criteria and required no intervention. Two events were Grade 2 CRS and resolved with the use of tocilizumab. Grade 2 ICANS occurred in one patient and improved within 24 hours of steroids. CTX110 in Dose Level 2 through Dose Level 4. CTX110 cells were detected in all patients as measured by PCR. Following CTX110 infusion, there was a transient decline in CTX110, which can be attributed to distribution of cells into compartments. Peak at Dose Level 3 and below, with no events of graft-versus-host disease or Grade 3 or higher of CRS or ICANS. The one patient recently treated at Dose Level 4 was a 73-year-old man with transformed follicular lymphoma who relapsed following autologous stem cell transplant. These correlates of data and will provide further updates at a future scientific meeting.
With that, I would like to turn the call over to Dr. McGuirk. That responded to tocilizumab. On day 25, the patient underwent his one-month scan and was found to be in complete response. After the one-month scan, the clinical course became complicated. The patient was admitted for febrile neutropenia on day 26, and shortly after, on day 28, began to have short-term memory loss and confusion. The symptoms eventually progressed to significant obtundation that required intubation.
We enrolled him on this trial and treated at Dose Level 3. He had an uncomplicated course after CTX110 infusion, did not have any CRS, ICANS, or infections. The patient had a clear response to CTX110 on physical exam with decreasing size of cervical lymph nodes.
Retrospective evaluation of the patient's blood collected at screening showed that he was HHV-6 IgG positive, consistent with prior HHV-6 infection. The diagnosis of HHV-6 encephalitis was based on CSF examination that revealed a high HHV-6 titer of approximately 650,000 copies per milliliter. Subsequently, he began a course of antiviral therapy, which continued for 13 days.
FDG avid. Per Lugano criteria, this would be considered stable disease. At that point, we decided to obtain a lymph node biopsy.
At day 52 post CTX110 infusion. We believe the exact etiology of neurological deterioration is likely due to a combination of HHV-6 reactivation in an immunocompromised patient that led to HHV-6 encephalitis and potentially ICANS.
Cleared the CD19 positive population, and only the CD19 negative remained and gave rise to subsequent persistence of disease.
Although disappointing, this case speaks to the on-target activity of CTX110 and could potentially be addressed by future iterations of CAR-T products.
Present all patients as measured by PCR. Following CTX110 infusion, there was a transient decline in CTX110.
A 62-year-old woman who was diagnosed with diffuse large B-cell lymphoma. She had initially received six cycles of R-CHOP, achieving only a partial response. She then received RICE salvage chemotherapy and similarly, achieved only a partial response before receiving busulfan cyclophosphamide conditioning followed by an autologous stem cell transplant. This year, she relapsed and was referred to our center for further management.
With that, I would like to turn the call over to Dr. McGuirk, who will present case studies on two of his patients treated with CTX110.
Thank you. She was enrolled on this trial and treated at Dose Level 3. She had an uncomplicated course without any CRS, ICANS, or infections. Of mine is a 62-year-old male with transformed follicular lymphoma who previously received two lines of therapy, including R-CHOP. For her three-month follow-up, she remains in complete remission with no toxicities.
Thank you, Dr. McGuirk. We are very encouraged by CTX110.
CTX110 infusion, did not have any CRS, ICANS, or infections. The patient had a clear response to CTX110 on physical exam with decreasing size of cervical lymph nodes. In fact, I can see this patient's lymph nodes from across the exam room. At day eight.
Four patients. While we have seen early signs of durability, we will continue to monitor the ongoing complete responses.
We see an acceptable safety profile at Dose Level 3 and below, with no GvHD and low grades and rates of CRS and ICANS. Furthermore, no additional Size of the lymph nodes. On PET, the lymph nodes remained FDG avid. Per Lugano criteria, this would be considered stable disease. Already becoming evident with 100% of enrolled patients receiving treatment without need for bridging chemotherapy or worry about manufacturing failures. Furthermore, we observed responses across multiple lots of CTX110 manufactured from different donors, suggesting that, as anticipated, CAR T.
This suggests that the CAR T cells had cleared the CD19 positive population, and only the CD19 negative remained.
Makes us excited to progress CTX110 as well as CTX120, CTX130, and additional allogeneic CAR T programs forward as rapidly as possible. To that end, we are moving full steam ahead on CTX110.
We plan to proceed into an expansion cohort in the near term following selection of an optimal dose. In addition, we have now included redosing as an option for patients who relapse or do not achieve a complete response, and we have already redosed one patient. We believe that the ability to redose before receiving the cyclophosphamide conditioning followed by an autologous stem cell transplant. This year, she relapsed and was referred to our center. We continue to make rapid progress on CTX120 and CTX130 with dosing ongoing across trials in multiple myeloma,
confirmed to be diffuse large B-cell lymphoma on biopsy. She was enrolled on this trial and treated at Dose Level 3. She had an uncomplicated course without any CRS, ICANS, or infections. I'm excited to report that at a one-month assessment, there was no evidence of lymphoma by either PET or CT.
The subject is clinically very well. I just saw her about a three-month follow-up, and she remains in complete remission with no toxicities.
four years ago, we set out a concrete strategy. First, validate the allogeneic platform with proven targets, then expand from hematologic cancers into solid tumors, and finally, unlock the full potential of immuno-oncology cell therapy through CRISPR multiplex anti-tumor activity. With complete responses achieved in four patients. While we have seen early signs of durability, we will continue to monitor the achieve our first step towards accomplishing this ambitious goal by validating our allogeneic platform in the clinic. We are looking forward and ICANS. Furthermore, no additional lymphodepleting agents beyond a standard suicide regimen were required to achieve these responses.
Finally, the advantage of the allogeneic approach are already becoming evident, with 100% of enrolled patients receiving treatment without need for bridging chemotherapy or worry about manufacturing failures. Furthermore, we observed responses across multiple lots of CTX110 manufactured from different donors, suggesting that, as anticipated, this approach can scale to benefit as many patients as possible. In all, we believe this data validates our CRISPR-edited allogeneic CAR-T approach and makes us excited to progress CTX110, as well as CTX120, CTX130, and additional allogeneic CAR-T programs forward as rapidly as possible. To that end, we are moving-
Congrats on the updates, thanks for taking my question. I just had a two-part question.
We have now included redosing as an option for patients who relapse or do not achieve a complete response, and we have already redosed one patient. We believe that the ability to redose with CTX110 provides an additional advantage that will increase our ability to achieve durable, complete responses in as many patients as possible. We continue to make rapid progress on CTX120 and CTX130, with dosing ongoing in cross trials in multiple myeloma, renal cell carcinoma, and T and B cell lymphoma.
The NK cells as well as ICANS. We're collecting all sorts of information on these patients, whether they're-
CTX130, which includes both novel targets and novel edits, and we plan to announce additional progress in 2021. When we initiated our allogeneic CAR-T efforts four years ago, we set out a concrete strategy. First, validate the allogeneic platform with proven targets, then expand from hematologic cancers into solid tumors, and finally, unlock the full potential of immuno-oncology cell therapy through CRISPR multiplex editing. Our IO pipeline reflects that strategy.
potentially increase the risk of ICANS. In addition, the inclusion/exclusion criteria for our trials is very similar to what's been done with.
platform in the clinic. We are looking forward to continuing to innovate novel CAR-T designs and investigating them in the clinic with the aim of bringing multiple transformative off-the-shelf CAR-T therapies to patients. None of this would be possible without our investigators, site staff, and above all, patients and their families who have had the courage to participate in this groundbreaking clinical-
How many patients with follicular lymphoma versus DLBCL, particularly in the dose level, the two.
Thank you. We'll take our first question from Maury Raycroft of Jefferies.
Hi, good morning, everyone. Congrats on the updates, and thanks for taking my question. I just had a two-part question. I'm wondering if you can talk about whether you're seeing NK cell proliferation or activity, and is this related to CRS or any other safety observations? For the grade 2 ICANS or other SAEs, can you provide more specifics or comments on potential influence from baseline characteristics
Including CNS involvement or number of immune cells in CSF at baseline, and can you mitigate for these issues going forward?
Yeah. Thank you, Maury. We're quite excited to present these data today and very excited about the complete responses we're seeing. To your two questions on the pharmacokinetics and the NK cells as well as ICANS. We're collecting all sorts of information on these patients, whether they're cell proliferation of our CAR-Ts, what happens to the host immune system. At the right medical meeting, we'll present all the data holistically. You'll see more on that. We're very excited, though, the fact that our CAR-Ts persist for a very long time and can be detectable up to 180 days, which was one of the key hypotheses in making the B2M edit.
It looks like the complete response from the Dose Level 2 patient was about out to six months or so. Is that what you would also expect to see?
That we have noted thus far that potentially increase the risk of ICANS. In addition, the inclusion exclusion criteria for our trials is very similar to what's been done with other allogeneic CAR T-cell trials where ICANS has been seen as well.
Our next question is from Gena Wang of Barclays. Your line is open.
Thank you for taking my question.
Such a long response at Dose Level 2, which is a suboptimal dose, gives us great confidence that when we see deeper responses at Dose Level 3.
I think I heard it, follicular lymphoma. I just wanted to confirm how many patients with follicular lymphoma versus the DLBCL, particularly in the Dose Level 2 to 3. Also regarding more the technical part, I wanted to ask you regarding the co-stimulatory domain, was that CD28 or 4-1BB? Lastly, very quickly on the IP, do you have IP on B2M knockout technology?
Yeah. Thank you, Gena. I'll start with your last question first, which is, we filed extensively in terms of IP on our CAR-T constructs, whether it's the B2M edit or other aspects. CRISPR gene editing just makes better quality T-cells and CAR-Ts. They're healthier and more robust in terms of cytotoxicity. That's something that the top line answer, and then I'll ask Evelina to provide more details here. I think the N is small, but I think it's very encouraging. I think we again protect the overall construct with IP with many different filings that you'll see over time. I think to DLBCL or TFL or whether they're primary refractory or relapse gives us great confidence. I think this is a very important update for the trial. I just want to emphasize the transformed follicular aspect.
We're looking at very serious follicular patients, not indolent follicular patients here. We see complete responses in both DLBCL and transformed follicular.
Take our next question from Jeff Meacham of Bank of America.
Hi, guys. This is Greg Harrison for Jeff. Thanks for taking the question. It looks like the complete response from the Dose Level 2 patient was about out to six months or so. Is that what you would also expect to see in the ongoing CRs in Dose Level 3?
As Sam mentioned, our hope and we're incredibly encouraged by what we're seeing right now that redosing may not be necessary, but it's an option on our file.
Long durable responses. Let me just remind you and contextualize the fact that durability ultimately is a function of both how deep the responses are.
The 12 patient dose was on Dose Level 3.
Gives us great confidence that when we see deeper responses at Dose Level 3 and above, we eventually should translate into durability in the clinic.
Are those learnings from this study that you think can apply to the other CAR-Ts? How do you see this as building the foundation to start to do multiplex with respect to additional targets? Thank you so much.
Yeah. Thank you, Ted. I'll start.
For taking my question. Just given the small Ns in each of the dose cohorts, can you just discuss your work on the forward here to better determine dose for-
Folks, I think as a company, we only have been around for five years as a brick-and-mortar company. Within that time, we came up with the CTX001 program, disclosed that data last year, which can be transformative. Then in parallel, have developed a host of three different CAR-Ts, which are all in clinical trials right now and enrolling. Thank you, Gena. I'll start with a top line answer, and then I'll ask Evelina to provide more details here. I think the N is small, but I think it's very encouraging. I think of the four patients that we've dosed at Dose Level 3 and the patient at Dose Level 4, I think seeing complete response was in these patients, whether they're DLBCL or TFL or whether they're primary refractory or relapse, gives us great confidence.
I think this is a very important update for the trial as we look to expand the number of sites, as we look to bring more patients in. Transformative and have an important place in the lines of treatment for these patients that have limited options. I think beyond that, I think the thesis with the hope that that can become the registrational trial, assuming the data continue to hold. I think we haven't said exactly what that expansion dose is going to be, and we will continue to update the street as we go along in the trial. At this point, I think we're full steam ahead on this trial. Once we complete the dose response, then we want to get into expansion. I think to the second question around the redosing of that patient, I will turn it over to Evelina.
Thanks, Sam. As Sam mentioned, our hope and we're incredibly encouraged by what we're seeing right now that redosing may not be necessary, but it's an option on our trial, and we provide this option to patients that have either relapsed or patients that have had some kind of a response, but not full complete remission. The 12 patient dose was on Dose Level 3.
Our next question is from Ted Tenthoff of Piper Sandler.
Great. Thank you very much. Positive update. Are there learnings from this study that you think can apply to the other CAR-Ts?
Raju Prasad of William Blair.
Thanks for taking the question. Just a couple of questions on the cell product.
Yeah, thank you, Ted. I'll start, and then I'll ask Tony to make some comments as well. I think this is very exciting.
With regards to peak or durability and your responses, and then anything you can say on % of the B2M knockout or knockdown?
Within that time, we came up with the CTX001 program, disclosed that data last year, which can be transformative. In parallel, have developed a host of three different CAR-Ts, which are all in clinical trials right now and enrolling rapidly. I think we're moving along on CTX120, which is targeted towards BCMAs regardless of the healthy donor lots that we're using, more than one. Obviously, we take a lot of robust characterization to assess with CTX110, does give us great confidence in what we may see with CTX120 and CTX130. We will have data updates for those two programs next year, as well as additional data on CTX110. I think that one gives us confidence negative. I think that we will disclose that very important data, and as you can imagine, it's highly competitive data.
I think the B2M edit gives us a distinct advantage over other players in the allogeneic field, and we're filing IP on various aspects of it as we go along. We will disclose the data of how the cells behave with or without B2M edits. It's very encouraging, as Tony was saying, that we see these cells, the continuing work and how we see this over the next five, 10 years.
Sure. I think as you have seen, our initial data give us a lot of confidence.
Providing holistic data at that medical meeting where we show the comparison, the pharmacokinetics, et cetera.
Both blood and the bone marrow out to day 180, really sort of validated our allogeneic immune-based platform. We're very excited to sort of build on the chassis to add additional edits and also additional target. These could be edits that resist a tumor microenvironment, exhaustion to resistance, and select targeting. We can build things that elicit endogenous immune response. I think this is just a start, and we're looking forward to continue build our platform.
For the cell type versus responders or non-responders. We haven't disclosed that information at this point, but I think we did show a chart that showed the cell expansion chart, and you do see a curious expansion in the first 7- 10 days. You see a lot of the expansion happening.
Any signs you're seeing kind of engraftment with regards to peak or durability and your responses, and then anything you can say on percentage of the B2M knockout or knockdown would be helpful. Thanks.
Thank you, Raju. I think what we did disclose.
Certainly, we're still learning from these data. Most importantly, we saw CTX110. We're detecting multiple time points all the way to day 180.
We are seeing effect in patients and responses regardless of the healthy donor lots that we're using, more than one. Obviously, we take a lot of robust characterization to select healthy donor lots that we want for this manufacturing. We have used multiple healthy donor lots to make these drug products, and we're seeing responses across multiple lots. That's very encouraging.
Seeing chemotherapy and able to create a window for CTX110 expansion.
I think the B2M edit gives us a distinct advantage over other players in the allogeneic field, and we're filing IP.
Our next question is from Arlinda Lee, Canaccord Genuity.
Hi, guys. Congratulations on-
It's very encouraging, as Tony was saying, that we see these cells persist for a very long time.
That you've seen anything in your CTX120 or CTX130 with regards to that, or have you changed your protocols with regards to that? Then maybe for Dr. McGuirk, how do you see bridge to another treatment, or are you looking for greater durability? Thank you.
Hey, thank you very much. Congrats on the data. I was wondering if you could provide any additional color on the expansion that you're seeing? I guess, are you seeing better expansion in patients who respond, and are you seeing better expansion at higher dose levels?
Yeah. From a clinical perspective, in a program that has done a lot of cell therapy, not all in clinical trials and in the commercial space, we see this as the next generation of therapies for our patients with specific advantages to these constructs, and that it's, we think, importantly, a more fit population of T cells that have not failed to control tumor growth in the first place because they're not from the patient.
10 days, you see a lot of the expansion happening, and I think a lot of the activity of the CAR-T is happening very early on. That is an interesting profile for these allogeneic therapies. Let me turn over to Tony and see if he has any additional comments to make. The holistic data presentation will come-
We're very much encouraged with the signals that we're seeing in terms of both efficacy in each early dose.
Detect at multiple time point all the way to day 180 in our patients. Following CTX110 infusion, there was a transient decline of CTX110, which can be attributed to the distribution of these cell to different compartments, including the tumor. We saw peak expansions you have seen on the curve occurs for approximately one to two weeks after administration. We're encouraged to use this as the next generation. This is the future for our patients. That's why we're participating in this important study.
Thank you, Dr. McGuirk. Arlinda, to the second part of your question around the ICANS, I think Evelina disclosed the course of the clinical complications in the course of treatment for that patient.
Understood. Congrats again. Thank you.
Our next question is from Arlinda Lee, Canaccord Genuity.
Hi, guys. Congratulations on the data. I had a couple of questions. Maybe they could talk a little bit further about the ICANS. Then maybe for Dr. McGuirk, how do you see the use of CTX110 as a bridge to another treatment, or are you looking for greater durability? Thank you.
Thank you, Arlinda. Let me start with your second part of your question first, then turn it over to Dr. McGuirk on how he sees CTX-.
On the safety side, were the different doses associated with different levels of AEs? Just to a subsequent therapy. From a clinical perspective, in a program that has done a lot of cell therapy. In those levels too is not the patient that was redosed. I previously mentioned to one of your colleagues that the patient that was redosed with the. That it's, we think, importantly, a more fit population of T cells that have not failed to control tumor growth in the first place because they're not. I think Dose Level 4 was an unfortunate case that occurred and had very complicated neurological course that was both a result of lymphodepletion. That are very specific.
We think it's a more physiologically active, less likely to become exhausted population of cells that will persist, as you heard from the scientists at CRISPR discuss here just a moment ago. We're very much encouraged with the signals that we're seeing in terms of Continue to hope that that continues, and we'll continue monitoring very closely.
Yeah, thank you, Evelina. I will just add, Gena, to your question, you heard from.
Of whom we've discussed today has a durable complete response. Our experience with the autologous constructs is that majority of patients who go into complete remission are staying in complete remission long term. We expect, and I'll just extrapolate it, we expect that we're going to see the same thing here. We're greatly encouraged about the potential here. We really think, again, this is the next generation. This is the future for our patients. That's why we're participating in this important study.
Thank you, Dr. McGuirk. Arlinda, to the second part of your question around the ICANS, I think Evelina disclosed them, as well as providing you updates on CTX120 and CTX130.
Due to brevity of time, this does conclude our question and answer session, as well as our conference call for this morning. You may now disconnect your lines, and everyone, have a good day.
Patients at Dose Level 3.
Hi, guys. Thanks for taking my questions, and congrats on the data as well. One of the questions in Dose Level 2 who may have relapsed, is that?
Associated with different levels of AEs.
Yeah. Let me turn it over to Evelina to answer that question.
Neurological course that was both a result of lymphodepletion, HHV-6, for encephalitis and ICANS. As Sam mentioned, we're going to continue evaluating it to treat patients. I just wanted to point out that all the patients treated at Dose Level 3 had no CRS.
Yeah, thank you, Evelina. I will just add, Gena, to your question, you heard from Dr. McGuirk. I really think as we look at the early responses here, build a chassis for the next generation of allogeneic cell therapies, which can have impact on these patients that have very limited options. I think on the safety as well, we see a relatively acceptable safety profile, and we're full steam ahead on these trials.
Due to brevity of time, this does conclude our question and answer session, as well as our conference call for this morning. You may now disconnect your lines, and everyone, have a good day.