A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients With Severe, Refractory Systemic Lupus Erythematosus

This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.

Start Date02 Feb 2024

Sponsor / Collaborator

Autolus Ltd.

NCT06173518

/ RecruitingPhase 1

A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients With CD19-Positive Relapsed/ Refractory (r/r) B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL)

This is a Phase Ib study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL)

Start Date16 Nov 2023

Sponsor / Collaborator

Autolus Ltd.

ACTRN12621000762853

/ RecruitingPhase 1IIT

Phase I Clinical Trial of MB.CART19.1 CD19 Chimeric Antigen Receptor (CAR)T Cells in Relapsed or Refractory CD19-Positive Haematological Malignancy

Start Date21 Jul 2021

Sponsor / Collaborator

Metro North Hospital & Health Service

100 Clinical Results associated with Obecabatagene autoleucel

100 Translational Medicine associated with Obecabatagene autoleucel

100 Patents (Medical) associated with Obecabatagene autoleucel

Literatures (Medical) associated with Obecabatagene autoleucel

23 Jun 2025·Expert Review of Hematology

Obecabtagene autoleucel, a novel CD19-directed CAR T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia: the future for reducing toxicity and T-cell exhaustion?

Review

Author: Yared, Jean A ; Rapoport, Aaron P ; Fromowitz, Ariel ; Kocoglu, Mehmet ; Hardy, Nancy ; Atanackovic, Djordje

INTRODUCTION:

Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) continue to face poor outcomes despite recent advances in immunotherapy. The development of chimeric antigen receptor (CAR) T-cell therapies has transformed the treatment landscape, yet challenges such as severe cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and limited T-cell persistence have hindered their broader applicability. Obecabtagene autoleucel (obe-cel), a novel CD19-directed CAR T-cell therapy featuring a fast off-rate binding domain, represents a significant innovation aimed at optimizing the balance between efficacy and toxicity in this high-risk population.

AREAS COVERED:

This review examines the pharmacologic and clinical development of obe-cel, with a focus on the unique receptor design that mimics physiologic T-cell receptor interactions to mitigate overactivation and exhaustion. Data from early-phase and pivotal trials, particularly the FELIX phase Ib/II study, are discussed in detail, highlighting efficacy outcomes such as a 77% overall remission rate and favorable safety profile with low rates of grade 3 or higher CRS (2.4%) and ICANS (7.1%). A comprehensive literature search was conducted using PubMed and clinical trial databases to identify peer-reviewed publications, reports, ongoing studies, and regulatory updates relevant to obe-cel and comparable therapies in R/R B-ALL.

EXPERT OPINION:

Obe-cel represents an important conceptual advancement in CAR T-cell therapy, offering a promising alternative to existing high-affinity CD19 CARs. The integration of kinetic receptor engineering and split-dose administration appears to enhance both safety and durability of response, potentially redefining treatment goals in R/R B-ALL. As real-world experience and longer-term data accrue, obe-cel may emerge not only as a bridge to transplantation but also as a definitive therapy for select patients. The success of this approach may inform future CAR design across hematologic malignancies and support a paradigm shift toward receptor-tuned cellular immunotherapies.

01 Jun 2025·Transplantation and Cellular Therapy

Awakening from REMS: ASTCT 80/20 Ongoing Recommendations for Safe Use of Chimeric Antigen Receptor T Cells

Review

Author: Mahmoudjafari, Zahra ; Kebriaei, Partow ; Locke, Frederick L ; Frigault, Matthew J ; Nikiforow, Sarah ; Perales, Miguel-Angel ; Frey, Noelle V ; Gardner, Rebecca A ; Komanduri, Krishna V

The first 6 chimeric antigen receptor T cell (CAR-T) therapies approved in the United States have Risk Evaluation Mitigation Strategies (REMS) programs mandated by the US Food and Drug Administration (FDA). REMS programs aim to ensure the safe use of CAR-T therapy through timely recognition and management of unique severe risks and toxicities that cannot be mitigated by labeling alone, such as cytokine release syndrome and neurotoxicity syndromes. At the launch of each of the first 6 products, CAR-T REMS programs mandated product-specific education and training for clinical staff, patients, and caregivers; adequate access to medications to treat expected toxicities; and reporting of toxicities either to the product manufacturer or to the FDA. Each manufacturer ensures that treatment centers comply with the REMS program for their individual product in different ways, involving time-consuming and often redundant training, testing, and audits. The American Society for Transplantation and Cellular Therapy (ASTCT) 80/20 Subcommittee convened its second workshop in June 2023, inviting approximately 70 cellular therapy stakeholders to discuss whether safety and quality workflows embedded in existing resources within the cellular therapy field could replace FDA-mandated and company-monitored REMS programs. Attendees were clinicians at large academic medical centers experienced in cellular therapy, regulators, members of accrediting bodies and professional societies, and manufacturers of immune effector cell (IEC) therapies at multiple stages of development. Discussion centered on (1) educational requirements for safe delivery and management, (2) goals and mechanisms for data reporting and to whom, and (3) what entities should oversee these quality safeguards around CAR-T administration and management. Broad support was voiced for (1) conducting training programs administered by treatment centers and/or professional societies to replace manufacturers' product training; (2) reporting standardized data points into a central, accessible repository for tracking of safety trends and identification of new signals; and (3) enabling accrediting bodies to attest to programs' quality and ongoing compliance with field safety expectations, thereby replacing intensive manufacturer initial evaluation and ongoing REMS audits. The strong consensus of the second multidisciplinary ASTCT 80/20 Workshop was that such measures would allow elimination, or at least significant reduction and simplification, of current CAR-T REMS programs. Development of educational resources and funding for data reporting outside of a mandated REMS structure were identified as critical, particularly to support treatment centers new to cellular therapy, as were ongoing collaborations with FDA and manufacturers. These consensus recommendations were shared with the FDA at the Cell Therapy Liaison Meeting and in multiple professional society meetings and other public forums with regulators, manufacturers, and FDA representatives. Recently the FDA scaled back several of the features of existing CAR-T REMS programs redundant to standard clinical practice, specifically requirements related to manufacturer-created training, product-specific testing of trained staff, and data reporting to manufacturers. The seventh commercial CAR-T product (Aucatzyl, or obecabtagene autoleucel) was the first approved without a REMS program as of November 8, 2024. Continued streamlining of already widespread CAR-T safety standards for existing and future approved CAR-T cells and other unique cellular therapy products and ensuring their adoption at new and existing treatment centers will be required to maintain and increase access to the ever-growing number of effective adoptive cellular therapies.

12 May 2025·LEUKEMIA & LYMPHOMA

Frontline immunotherapeutic combination strategies in adult B-cell acute lymphoblastic leukemia: reducing chemotherapy intensity and toxicity and harnessing efficacy

Review

Author: Haddad, Fadi G. ; Habib, Diane ; Senapati, Jayastu ; Short, Nicholas J. ; Jabbour, Elias ; Kantarjian, Hagop ; Jain, Nitin

Using immunotherapeutic agents like inotuzumab ozogamicin (InO), blinatumomab, or chimeric antigen receptor T (CAR T)-cell therapy in frontline adult B-cell acute lymphoblastic leukemia (B-ALL) therapy is promising. These agents are mostly well tolerated and have different toxicity profiles than conventional chemotherapy, enabling their combination with chemotherapy. Additionally, they have often been shown to overcome the traditional adverse ALL risk features. Recently blinatumomab was approved as part of consolidation therapy in MRD negative B-ALL; however, a significant proportion of patients had progressed or relapsed before reaching the timepoint of blinatumomab administration. Including InO/blinatumomab from induction onwards could induce earlier and deeper remissions. Modifications of dosing and administration schedules, as with the fractionated InO schedule with low-intensity chemotherapy, and subcutaneous blinatumomab, appear to reduce the toxicity and improve the anti-ALL efficacy. CAR T-cell therapies like brexucabtagene autoleucel as a consolidation approach have shown positive outcomes. The feasibility of using CAR T-cells to reduce the need for long-drawn maintenance and the need for allogeneic hematopoietic stem cell transplantation (HSCT) are questions of ongoing clinical trials. Newer generation CAR T-cell products like obecabtagene autoleucel appear as effective and safer. Better disease monitoring through next generation sequencing based measurable residual disease analysis could identify patients where treatment intensification including HSCT, or deintensification, is suitable.

News (Medical) associated with Obecabatagene autoleucel

30 Jun 2025

·www.pharmaceutical-technology.com

FDA removes safety programme for CAR-T therapies to boost uptake

CAR-Ts, the first of which were initially approved in June 2025, have demonstrated a wealth of efficacy in haematological oncology indications. Credit: Nemes Laszlo via Shutterstock. The US Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategies (REMS) requirements for all approved autologous chimeric antigen receptor (CAR-T) cell immunotherapies, saying the access barrier is no longer needed for the modality. REMS is a safety programme that the FDA requires for certain serious safety concerns to help ensure the benefits of the medication outweigh its risks. It limits the access of approved drugs to certain hospitals and clinics that had to be specially certified for therapy administration and have access to anti-inflammatory medication. CAR-Ts, the first of which were initially approved in June 2025, have demonstrated a wealth of efficacy in haematological oncology indications by boosting the patients’ own T-cells to fight cancer cells. However, their use comes with the risks of cytokine release syndrome (CRS) and neurological toxicities. The FDA commented that REMS is no longer necessary to ensure that the benefits of BCMA-directed and CD19-directed CAR-T cell immunotherapies outweigh their risks. It added that the elimination of the access barrier would minimise burden on healthcare systems. Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), and Johnson & Johnson/Legend Biotech’s Carvykti (ciltacabtagene autoleucel) will have their REMS requirements removed. Novartis’ Kymriah (tisagenlecleucel), along with Gilead Sciences’ Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel), also stand to benefit from the FDA’s decision. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence A seventh FDA-approved CAR-T therapy – Autolus’ Aucatzyl (obecabtagene autoleucel) – will not be affected because it never carried a REMS requirement . “FDA has determined that the safe and effective use of CAR T cell immunotherapies for the indicated population can be assured without a REMS. Adverse event reporting for CRS and neurological toxicity have remained stable,” the agency said in a statement. William Blair analysts commented in a research note: “We view the removal of the REMS program for CAR-T cell therapies as a positive development for the space, as it supports the notion that the FDA is working to minimise red tape and increase access to potentially curative treatments for patients.” The agency said that safety information can be adequately conveyed using drug product labelling. This includes a boxed warning for the risks of CRS and neurological toxicities. A Gilead spokesperson told Pharmaceutical Technology : “This [decision] underscores the knowledge and experience that CAR-T treaters have gained to safely administer these therapies, and we are pleased that they will help lessen the burden on healthcare professionals and patients, enabling more people to receive these potentially curative treatments.” While continuous monitoring and assessment will still be carried out by the FDA, the removal of REMS is expected to facilitate patient access and is viewed as a positive development for the sector. “FDA expects that the REMS elimination, and these labelling updates, will help improve access to these products, particularly for patients who live in rural areas, while ensuring safe and effective administration to patients who need them,” the agency commented. William Blair analysts agreed, saying that “the removal of the REMS requirements could increase access and use of these therapies in the community settings”. “This update also suggests we may not see REMS requirements for CD19 and BCMA autologous CAR-T cell therapies in the future,” the research note added. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Navigating cell therapy process development The cell therapy manufacturing sector is rapidly evolving, driven by the need to balance innovative process development with rigorous GMP standards. This eBook, brought to you by industry leaders Cytiva, explores how biotech firms can address common challenges — including minimizing contamination risks from manual processes, overcoming resource limitations, and creating scalable, robust designs. Industry experts discuss strategies including automation, strategic outsourcing, and flexible equipment selection to streamline processes and reduce regulatory risks. To unlock expert insights on optimizing your cell therapy pathway from clinical development to commercialization, fill in your details now. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic You have a right to withdraw your consent at any time, by clicking here . We may still continue to send you service-related and other non-promotional communications. For more information relating to our privacy practices, we invite you to review our privacy policy . Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

ImmunotherapyCell TherapyDrug Approval

27 Jun 2025

·www.fiercepharma.com

FDA removes CAR-T access barriers in move set to boost cancer immunotherapy uptake

The FDA expects that the REMS elimination and reduced post-infusion restrictions will help improve access to CAR-T therapies, particularly for patients who live in rural areas. Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now.The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved BCMA- and CD19-directed CAR-T therapies, the agency said Thursday.Existing commercial CAR-T products, including Bristol Myers Squibb’s Abecma and Breyanzi, Gilead Sciences’ Yescarta and Tecartus, Johnson & Johnson and Legend Biotech’s Carvykti, and Novartis’ Kymriah, stand to benefit from the update. Autolus’ CD19 CAR-T Aucatzyl was approved in November for B-cell precursor acute lymphoblastic leukemia without a REMS requirement. The FDA’s website only has updated prescribing information for Carvykti as of publication time, but the agency's announcement said the REMS requirements have been removed for all these drugs.The FDA previously required the REMS safety program for each approved CAR-T drug because of the risk of cytokine release syndrome and neurological toxicities associated with the drugs.Under the REMS program, hospitals and clinics had to be be specially certified to be able to administer CAR-T therapies.Now, though, the FDA has determined that the demand is no longer necessary “[g]iven the established management guidelines and extensive experience of the medical hematology/oncology community in diagnosing and managing” the safety risks, according to an FDA approval letter (PDF) for Carvykti.Post-treatment monitoring of patients no longer has to be carried out at certified healthcare facilities, according to the FDA. In addition, patients are now asked to remain within close proximity of a healthcare facility for two weeks, rather than the previously mandated four weeks.Previously, patients were instructed to refrain from driving for at least eight weeks following infusion. Now, the new labels have shortened that period to two weeks.“These changes should facilitate patient access, particularly for those who do not live near centers of excellence where CAR-Ts are commonly administered,” Citi analysts wrote in a Friday note.“FDA expects that the REMS elimination, and these labeling updates, will help improve access to these products, particularly for patients who live in rural areas, while ensuring safe and effective administration to patients who need them,” the agency said in its announcement.Following the FDA’s move, BMS said it has launched “a renewed effort to add community cancer centers nationwide to administer Breyanzi and Abecma closer to patients, helping further reduce travel time and duration of stay away from home, family and work.” In a statement to Fierce Pharma, Gilead said the update “underscores the knowledge and experience that CAR T treaters have gained to safely administer these therapies,” and that the company is pleased the change “will help lessen the burden on HCPs and patients, enabling more people to receive these potentially curative treatments.” The REMS requirements were a major burden that discouraged referrals from community doctors and affected patients’ willingness to receive a CAR-T drug, Leerink Partners analysts wrote in their own Friday note, citing two blood cancer experts. One expert told Leerink that he would expect reduced monitoring requirements and driving restrictions would double the current uptake of CAR-T therapies.The revisions are especially beneficial to the CD19 lymphoma CAR-T meds because their market penetration has remained stagnant at about 20% for some time, the Leerink analysts noted.The removal of the REMS programs in their entirety follows an FDA decision last year to eliminate requirements for educational and training materials, as well as a mandate to report adverse events suggestive of CRS or neurological toxicities, specifically under REMS. The move represents a positive sign of some regulatory continuity at the FDA’s cell and gene therapy department since the installment of several new leaders, including the new Center for Biologics Evaluation and Research (CBER) director, Vinay Prasad, M.D., and the reported sudden ouster of Nicole Verdun, M.D., director of the Office of Therapeutic Products within CBER last week. While the REMS items are gone, the CAR-T products’ labels still carry black box warnings about CRS, neurotoxicity and secondary T-cell malignancies. During an interview last fall, then-CBER Director Peter Marks, M.D., Ph.D., told Fierce that the agency was reevaluating the classwide secondary cancer warnings that were recently slapped on CAR-T therapies’ labels.

ImmunotherapyDrug ApprovalCell TherapyGene Therapy

27 Jun 2025

·www.biopharmadive.com

FDA takes major step to ease access to CAR-T therapy

Dive Brief:The Food and Drug Administration is easing limitationsit imposed around the complex cancer drugs known as CAR-T therapies, removing several onerous requirements as well as loosening restrictions on which facilities can provide treatment.The FDAs action applies to therapies made by Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson and Novartis that are used to treat several types of blood cancer. Specifically, it removes so-called Risk Evaluation and Mitigation Strategies from the drugs labeling, which are used to help manage serious side effects of treatment.According to the FDA, these REMS requirements are no longer necessary to ensure safe use of these CAR-T therapies as both physicians and hospitals are now well versed in managing the two syndromes most commonly associated with the drugs.Dive Insight:Since the FDAs approval of Novartis Kymriah for leukemia in 2017, six more CAR-T therapies have reached market. These medicines are made from a patients own immune cells, extracted from the body and engineered in a lab to hunt down specific proteins found on the surface of malignant clones.For some people with leukemia, lymphoma or multiple myeloma, they can prompt powerful responses and even long-lasting remission. But their administration also comes with notable risks, including a hyperactive immune response known as CRS and neurological toxicity dubbed ICANS.When CAR-T therapies were new, physicians and the hospitals they worked at faced a learning curve handling these treatment-associated conditions, which require specific management and drugs to bring under control.The REMS imposed by the FDA was designed to help mitigate these risks by requiring hospitals receive special certifications before they could administer treatment, and mandating specialized reporting of side effects to the agency.Given the established management guidelines and extensive experience of the medical hematology [and] oncology community in diagnosing and managing the risks of CRS and neurologic toxicities across products in the class of BCMA- and CD19-directed autologous CAR-T cell immunotherapies, FDA has determined that the safe and effective use of CAR-T cell immunotherapies for the indicated population can be assured without a REMS, the agency said in a Thursday statement. BCMA and CD19 are the protein targets of the seven approved CAR-T therapies.Reporting rates for CRS and ICANS have remained stable, the FDA added.Alongside removal of the REMS, the regulator also reduced its requirement that patients remain nearby the facility they received treatment from one month to two weeks. And its limitation on how long patients must wait before they can drive or operate machinery again after treatment is lowered from two months to two weeks.Removal of the REMS should lower the logistical hurdles patients face in receiving CAR-T treatment as well as the cost of administration, the Alliance for Regenerative Medicine, a trade group, said in a post to LinkedIn.We believe the reduction in CAR-T burden for patients and caregivers, enabled by FDA's new monitoring and driving requirements, will drive expansion of the U.S. cell therapy market, Daina Graybosch, an analyst at Leerink Partners, wrote in note to clients.In a statement, Bristol Myers, which sells the CAR-T therapies Abecma and Breyanzi, noted that only two in 10 eligible patients receive the treatments due to the confluence of complex logistical and geographic barriers affecting patients and providers.The changes could help expand use of CAR-T from specialized medical institutions, where its most commonly given, to community health centers, Bristol Myers said.Breyanzi, Kymriah and Gileads Yescarta and Tecartus are cleared to treat lymphoma, although Kymriah is more commonly used for leukemia, where it is also approved. Abecma and J&Js Carvykti are used for multiple myeloma.The most recently OKd CAR-T treatment, Autolus Therapeutics Aucatzyl for lymphoma, was the first to be cleared without an initial REMS program. '

ImmunotherapyCell TherapyDrug ApprovalAccelerated ApprovalClinical Study

100 Deals associated with Obecabatagene autoleucel

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Pre B-cell acute lymphoblastic leukemia	United States	Autolus Ltd.	08 Nov 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent B Acute Lymphoblastic Leukemia	NDA/BLA	United States	Autolus Therapeutics Plc	29 Nov 2023
Refractory B Acute Lymphoblastic Leukemia	NDA/BLA	United States	Autolus Therapeutics Plc	29 Nov 2023
Lupus Nephritis	Phase 2	-	Autolus Ltd.	01 Jul 2025
Philadelphia positive acute lymphocytic leukaemia	Phase 2	United States	Autolus Ltd.	03 Jun 2020
Philadelphia positive acute lymphocytic leukaemia	Phase 2	Spain	Autolus Ltd.	03 Jun 2020
Philadelphia positive acute lymphocytic leukaemia	Phase 2	United Kingdom	Autolus Ltd.	03 Jun 2020
Systemic Lupus Erythematosus	Phase 1	Spain	Autolus Ltd.	02 Feb 2024
Systemic Lupus Erythematosus	Phase 1	United Kingdom	Autolus Ltd.	02 Feb 2024
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 1	United States	Autolus Ltd.	16 Nov 2023
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 1	Spain	Autolus Ltd.	16 Nov 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04404660 (FELIX, ASCO2025)	Phase 1/2	Recurrent B Acute Lymphoblastic Leukemia CD19	127	Obe-cel	tncuyqwtxd(nybjskibon) = yjkvuhqckv wcrflnjyhv (gzdxfdeurd, 60.9 - 81.7)	Positive	30 May 2025
				obecabtagene autoleucel (obe-cel) (Age <55 years)	xskqynorkj(ilorndpjme) = tuwzrpzdoc gjskusbmex (wwgmpotvsc ) View more
NCT04404660 (FELIX, EHA2025)	Phase 1/2	Refractory B Acute Lymphoblastic Leukemia CD19	127	Obe-cel <55 years	eblbgzjaco(haatciekuh) = ralbcyliwd yfahzafiac (ndtlrcxrkq ) View more	Positive	14 May 2025
				Obe-cel ≥55 years	eblbgzjaco(haatciekuh) = equsrihzls yfahzafiac (ndtlrcxrkq ) View more
NCT04404660 (FELIX, ASH2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia CD19	127	Obecabtagene autoleucel (obe-cel)	clipuhyuzd(ghbgicwrkr) = 72 (70.6%) were CRS only xwcfvgogfi (hqtgscmzee ) View more	Positive	09 Dec 2024
NCT04404660 (FELIX, ASH2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia ClonoSEQ®next-generation sequencing (NGS) assay	127	Obe-cel	cqyoubdrdr(ksyzygxspm) = imlqcnwzya mxgiwdxnlr (tamnptcouv ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Recurrent B Acute Lymphoblastic Leukemia	-	Obecabtagene autoleucel (obe-cel) (High-risk HT score)	adwzksnaqk(tvcmjeghlm) = chtbdzbopl iqfjvmbpri (slwqcgcvus, 34.6 - 55.6) View more	-	09 Dec 2024
				Obecabtagene autoleucel (obe-cel) (Low-risk HT score)	adwzksnaqk(tvcmjeghlm) = vrpovsaasi iqfjvmbpri (slwqcgcvus, 40.2 - 82.1) View more
ASH2024	Not Applicable	Recurrent Adult Acute Lymphoblastic Leukemia	-	Bridging Therapies with Inotuzumab Ozogamicin (INO)	vhndhcznje(hnvebdfsxb) = htdeglebsz kagqkynxoy (ybbjhcbzbg, 4.1 - NE) View more	-	08 Dec 2024
				Bridging Therapies without Inotuzumab Ozogamicin (INO)	vhndhcznje(hnvebdfsxb) = ekxwemixti kagqkynxoy (ybbjhcbzbg, 6.0 - 15.0) View more
NCT04404660 (FELIX, FDA_CBER) Manual	Phase 1/2	Pre B-cell acute lymphoblastic leukemia	112	AUCATZYL (Efficacy Evaluable)	khqbtiwqqv(woazuoxwbs) = oznfzixaji fudosyupkr (glxjiuxrls, 50 - 75) View more	Positive	08 Nov 2024
				AUCATZYL (All Leukapheresed)	khqbtiwqqv(woazuoxwbs) = wgjznlzqgc fudosyupkr (glxjiuxrls, 44 - 63) View more
NCT04404660 (FELIX, SOHO2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia	127	Obecabtagene Autoleucel (Obe-Cel) (Low TB)	txdsvqazww(vynuiauria) = zrlmxreyak wjqpeuaklw (iejibvaisu, 1.527–2.802) View more	Positive	04 Sep 2024
				Obecabtagene Autoleucel (Obe-Cel) (High TB)	qehgsvfxfw(htmfiwvpvl) = yubhskcsok mnwiijbyyj (ulntcxghtk ) View more
NCT04404660 (FELIX, ASCO2024) Manual	Phase 1/2	Recurrent B Acute Lymphoblastic Leukemia \| Refractory B Acute Lymphoblastic Leukemia CD19 binder	127	Obe-cel	jutwdbpdxu(szdjtizgsz) = Pts who experienced B-cell recovery had a hazard risk of relapse or death 1.7 times compared with pts without B-cell recovery ranxbymolk (jyuprekkln ) View more	Positive	24 May 2024
				Obe-cel (with censoring for consolidative SCT or new therapies)
NCT04404660 (FELIX, EHA2024) Manual	Phase 1/2	Pre B-cell acute lymphoblastic leukemia	127	Obecabtagene autoleucel (obe-cel)	hrpysomhck(gxajejttsb) = ebuzpbhfqq mgknkrtklx (zkwkywanfd ) View more	Positive	23 May 2024

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