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 CD19 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 1

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

159

Literatures (Medical) associated with Obecabatagene autoleucel

01 Dec 2024·American Journal of Hematology

Toxicities and outcome after CD19‐directed chimeric antigen receptor T‐cell therapy for secondary neurolymphomatosis

Article

Author: Doubrovinskaia, Sofia ; Abramson, Jeremy S. ; Hochberg, Ephraim P. ; Kaulen, Leon D. ; Barnes, Jeffrey A. ; Wick, Wolfgang ; Chen, Yi‐Bin ; Soumerai, Jacob D. ; Choi, Bryan D. ; Frigault, Matthew J. ; El‐Jawahri, Areej ; Shankar, Ganesh ; Maus, Marcela V. ; Martinez‐Lage, Maria ; Karschnia, Philipp ; Dietrich, Jorg ; Johnson, P. Connor

Lymphomatous infiltration of the peripheral nervous system (PNS), termed neurolymphomatosis, represents a distinct extranodal non-Hodgkin lymphoma variant with dismal outcome. CD19-directed chimeric antigen receptor (CD19-CAR) T-cell therapy has emerged as a safe and effective treatment for B-cell lymphomas. We aimed to assess toxicity and efficacy of CD19-CAR T-cells in neurolymphomatosis. Neurolymphomatosis patients treated with CD19 CAR T-cells were retrospectively identified at Massachusetts General Hospital over a six-year period. Toxicities were graded according to the ASTCT classification, management, and response rates were recorded. Eleven neurolymphomatosis patients were identified with a median of 2 lines of PNS-directed treatments (range: 1-3) prior to receiving CD19-CAR T-cells. Neurolymphomatosis localized to the nerve roots (8/11, 73%), plexus (5/11, 45%), peripheral (4/11, 36%) and cranial nerves (5/11, 45%). Low grade cytokine release syndrome (CRS) was detected in 8/11 (73%; grade 1: N = 7; grade 2: N = 1) cases. Low- and high-grade immune cell-associated neurotoxicity syndrome (ICANS) were recorded in 5/11 (45%; grade 1: N = 4; grade 2: N = 1) and 1/11 (9%; grade 4) patients, respectively. CRP levels at infusion were predictive of ICANS (area under the curve: 0.96, p = 0.01). Seven of eleven neurolymphomatosis patients (64%) responded to CD19-CAR T-cells. Complete remissions (CR) were achieved in three cases (27%), with 2 patients in sustained CR nine and 46 months after CD19-CAR infusion. Median progression-free survival (PFS) was 4 months. Collectively, CD19-CAR T-cell treatment was well tolerated and showed promising efficacy in recurrent neurolymphomatosis, a difficult to treat condition with unmet medical need. Findings suggest that CD19-CAR may sufficiently penetrate the blood-nerve barrier. Toxicity and outcomes were overall similar to CAR-T cell therapy in CNS lymphoma.

01 Dec 2024·Current Research in Translational Medicine

Point of care CD19 chimeric antigen receptor (CAR) T-cells for relapsed/refractory acute myeloid leukemia (AML) with aberrant CD19 antigen expression

Article

Author: Jacoby, Elad ; Shem-Tov, Noga ; Itzhaki, Orit ; Shouval, Roni ; Avigdor, Abraham ; Danylesko, Ivetta ; Yerushalmi, Ronit ; Toren, Amos ; Nagler, Arnon ; Shimoni, Avichai

Relapsed/refractory (r/r) acute myeloid leukemia (AML) is associated with poor prognosis. CD19 is a B-cell marker, is aberrantly expressed in AML, mostly with t(8; 21)(q22; q22.1). Here we report the results of a phase 2 study giving point of care produced CD19 CAR T- cells for r/r AML with aberrant expression of CD19 (NCT04257175). Lymphodepletion included fludarabine and cyclophosphamide The response was evaluated by bone marrow (BM) aspiration on day 28. Six patients (5 adults and 1 child) were included. Median number of previous chemotherapy lines was 4 (range, 3-8) and four patients received CAR T-cells 8-18 months post allogeneic hematopoietic stem cell transplantation (allo-HSCT). Cytokine release syndrome (CRS) of any grade occurred in all patients, and 1 patient had grade 3 CRS. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 2 patients at low grades. Tocilizumab was administered to 2 patients and corticosteroids to 3 patients. Four patients achieved a complete remission (CR), while 2/6 progressed (PD). Three patients (2 with CR and 1 with PD) underwent allo-HSCT (it was the second transplant in 2) 2-5 months post CAR T-cells infusion. The median duration of response in patients achieving CR was 8.5 (range; 3-14) months. However, all patients eventually died within 5 (1-18) months. In conclusion, CD19 CAR T- cell treatment for AML is feasible and safe. However, the response is short and should be followed by allo-HSCT. Hopefully, future long term results will be improved by combining the CAR T- cell therapy with the emerging novel effective anti-leukemic compounds.

01 Sep 2024·MedComm

Targeting chronic lymphocytic leukemia with B‐cell activating factor receptor CAR T cells

Article

Author: Luo, Yan ; Li, Shuhua ; Qie, Yaqing ; Murthy, Hemant S. ; Gadd, Martha E. ; Qin, Hong ; Rivera‐Valentin, Rocio ; Yassine, Farah ; Liu, Andrew ; Dronca, Roxana ; To, Tommy ; Shao, Qing ; Kharfan‐Dabaja, Mohamed A.

AbstractThe challenge of disease relapsed/refractory (R/R) remains a therapeutic hurdle in chimeric antigen receptor (CAR) T‐cell therapy, especially for hematological diseases, with chronic lymphocytic leukemia (CLL) being particularly resistant to CD19 CAR T cells. Currently, there is no approved CAR T‐cell therapy for CLL patients. In this study, we aimed to address this unmet medical need by choosing the B‐cell activating factor receptor (BAFF‐R) as a promising target for CAR design against CLL. BAFF‐R is essential for B‐cell survival and is consistently expressed on CLL tumors. Our research discovered that BAFF‐R CAR T‐cell therapy exerted the cytotoxic effects on both CLL cell lines and primary B cells derived from CLL patients. In addition, the CAR T cells exhibited cytotoxicity against CD19‐knockout CLL cells that are resistant to CD19 CAR T therapy. Furthermore, we were able to generate BAFF‐R CAR T cells from small blood samples collected from CLL patients and then demonstrated the cytotoxic effects of these patient‐derived CAR T cells against autologous tumor cells. Given these promising results, BAFF‐R CAR T‐cell therapy has the potential to meet the long‐standing need for an effective treatment on CLL patients.

115

News (Medical) associated with Obecabatagene autoleucel

14 Nov 2024

·www.prnewswire.com

Kyverna Therapeutics Announces New Patient Data Highlighting Potential of KYV-101 for Treatment of Lupus Nephritis in Symposium at ACR Convergence 2024

Positive Sustained Efficacy and Durability at >6-month Follow-Up Observed in Patients With Severe Lupus Nephritis (LN) Treated With KYV-101 Target Dose KYV-101 Treatment Continues to Demonstrate Robust Safety and Tolerability With No High-Grade CRS or ICANS Observed EMERYVILLE, Calif., Nov. 14, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, announces today that it will present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase 1/2 studies and named patient treatments. Kyverna, alongside leading academic collaborators, will highlight all six patients treated with the target dose of 1×108 CD19 CAR T cells, four of which have at least six months of follow-up. All patients at six months of follow-up after treatment at the target dose continue to display sustained efficacy and durability across numerous key clinical measures. These updates will be presented at a company symposium titled, "KYV-101 Anti-CD19 CAR T-Cell Therapy: The Future of Autoimmune Disease Treatment," to be held at 5:45 pm ET on November 18, 2024. Slides from the presentation will be posted to the company website following the symposium. "Lupus nephritis patients encounter a tremendous burden of disease associated with high morbidity and mortality, with up to 30% of patients ultimately experiencing end-stage renal disease that requires dialysis or kidney transplant," said Prof. Georg Schett, M.D. from the Friedrich-Alexander-University in Erlangen, Germany, and one of the presenters. "The data reinforce that treatment with KYV-101 drives deep B cell depletion in patients with LN, and appears to reset the immune system, stabilize eGFR, preserve kidney function and enable clinical improvement in SLE activity. Notably, this clinical benefit is occurring while also eliminating immunosuppressants and reducing glucocorticoids to physiologic levels with a manageable safety profile." "As our KYV-101 clinical datasets mature, we are increasingly able to focus on the right patients, treated at the right dose, with the right protocol. We are excited to share these new data, which continue to reinforce KYV-101's potential for durable and life-changing outcomes in lupus nephritis patients, including those with high chronicity and disease severity," said Warner Biddle, Chief Executive Officer at Kyverna. Additional Updates: Also at ACR Convergence 2024, Kyverna will present data on next-generation approaches, most notably with a poster on Ingenui-T, the Company's preclinical 3-day manufacturing process using autologous whole blood as starting material. Ingenui-T is designed to improve the patient experience by eliminating apheresis, leading to a potential for improved convenience, access and overall cost reduction. As the poster highlights, drug product from the Ingenui-T process manufactured with whole blood from patients with SLE or healthy donors displayed product characteristics similar to KYV-101. In addition, results from collaborative work on the molecular mechanisms underlying immune reset through deep B-cell depletion with CD19 CAR T-cell therapy performed in collaboration with Verily Life Sciences, an Alphabet precision health company, and the University of Erlangen will be shared as an oral presentation. The posters and slides from the oral presentation at ACR Convergence 2024 will be available on the publications page of Kyverna's website. About Lupus Nephritis (LN) Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE), more commonly known as lupus. Approximately 40 percent of adults diagnosed with lupus eventually develop LN and 60 percent or more of LN patients will fail standard of care and approved treatments1,2. Aside from modest efficacy, current treatments expose these young adults to the well-demonstrated detrimental consequences of chronic treatment with corticosteroids and other powerful immunosuppressants. Up to 30 percent of patients with LN will develop kidney failure, requiring dialysis or a kidney transplant to stay alive3 . About KYV-101 KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine4. KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials in the United States and Germany across two broad areas of autoimmune diseases, rheumatologic and neuroinflammatory, as well as in investigator-initiated trials for multiple indications in multiple geographies. The clinical experience to date with KYV-101 in both oncological and autoimmune diseases highlights the differentiated properties of KYV-101 and the potential to treat autoimmune patients. About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff-person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases. For more information, please visit . Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the potential impact of the clinical outcomes from the ongoing clinical programs; the potential impact of the new data on the treatment efficacy and safety profile of KYV-101; the potential that the results of the ongoing trials could drastically change the treatment landscape for the targeted autoimmune diseases; Kyverna's goals to develop certain paradigm-shifting treatment options; the potential for KYV-101 to provide durable, immunosuppressant-free remission for autoimmune disease patients; Kyverna's beliefs about the differentiated properties of KYV-101; and Kyverna's clinical trials and named-patient activities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Contact: Consort Partners for Kyverna: [email protected] Investors: [email protected] Media: [email protected] 1Anders et al., Nat Rev Dis Primers. 2020; 6:7. 2Parodis et al., Autoimmun Rev. 2024; 23:103418. 3Lateef and Petri, Arthritis Res & Ther. 2012; 14(Suppl 4):S4. 4Brudno et al., Nature Medicine. 2020; 26:270-280. SOURCE Kyverna Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell TherapyPhase 1Phase 2ImmunotherapyClinical Result

11 Nov 2024

·endpts.com

FDA approves Autolus’ CAR-T cell therapy for aggressive blood cancer

US regulators gave the green light to Autolus Therapeutics’ cell therapy for adult B cell precursor acute lymphoblastic leukemia, or B-ALL, that has returned or is not responding to prior treatment. Autolus will market its CD19-targeted cell therapy as Aucatzyl, according to the FDA’s announcement Friday, which came about a week earlier than the agency’s decision deadline. Autolus did not immediately disclose the list price for Aucatzyl, which is known generically as obecabtagene autoleucel, or obe-cel. The US approval lands Aucatzyl in the same market as Gilead’s Tecartus, which was approved for B-ALL in 2021. Like other cell therapies, Aucatzyl comes with a boxed warning for cytokine release syndrome and neurologic toxicities, as well as secondary blood cancers. The warning notes broadly that “T-cell malignancies have occurred” with CAR-T cell therapies, though like Tecartus, no cases of secondary cancers have been reported from Aucatzyl. However, the FDA did not require a special safety, or REMS, program for Aucatzyl. The agency earlier this year loosened safety reporting requirements for CAR-T therapies, a move the FDA said was to minimize burden on the healthcare system, and that came at a time when physicians have said they are more used to treating the side effects of CAR-T therapies. Notably, Aucatzyl’s FDA label cited efficacy data from a subgroup of patients in Autolus’ pivotal FELIX study. The agency focused on a 65-patient cohort with morphological disease and > 5% blasts in the bone marrow after screening. Of those patients, 63% achieved complete remission (at any time). By comparison, Autolus had reported that in a pooled analysis of 127 patients, 78% of patients achieved complete remission. Autolus will manufacture Aucatzyl at its commercial manufacturing site in Stevenage in the UK. The cell therapy is also under review in the UK and EU.

Cell TherapyImmunotherapyDrug ApprovalClinical ResultClinical Study

11 Nov 2024

·www.pharmaceutical-technology.com

Autolus secures FDA approval for CAR-T cell therapy use in ALL

Autolus’ Aucatzyl is a B-lymphocyte antigen CD19 CAR-T cell therapy. Credit: NDAB Creativity via Shutterstock. Autolus Therapeutics has secured US Food and Drug Administration (FDA) approval for Aucatzyl (obecaktagene autoleucel), its chimeric antigen receptor (CAR)-T cell therapy for adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukaemia (B-ALL). The approval follows a heightened regulatory focus on CAR-T cell therapy safety this year. In April, the FDA mandated boxed warnings for these therapies due to rare cases of T cell malignancies. Aucatzyl’s labelling includes these standard warnings for risks associated with cytokine release syndrome (CRS) and neurologic toxicities. The FDA’s approval decision was based on data from the FELIX trial (NCT04404660), which evaluated the therapy in adult patients with relapsed or refractory B-ALL. In a subgroup of 65 patients with morphological disease and over 5% bone marrow blasts, Aucatzyl demonstrated a 63% overall complete remission (CR). The main efficacy outcome — CR within three months — was achieved in 42% of patients, with a median duration of remission of 14.1 months. Aucatzyl showed a relatively low incidence of severe adverse events in the FELIX trial, with only 3% of patients experiencing Grade 3 CRS and 7% reporting Grade 2 or 3 immune effector cell-associated neurotoxicity syndrome (ICANS). There were no Grade 4 or 5 CRS events. Despite the risks, the FDA did not require a risk evaluation and mitigation strategy (REMS) programme for Aucatzyl, a decision in line with recent regulatory changes aimed at easing CAR-T therapy monitoring requirements. In June, the FDA removed a requirement for clinicians to report serious cases of the two most common side effects as part of its REMS programme for Gilead’s treatments Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). REMS programmes are typically implemented after drug approval when the FDA determines that a medication needs to be closely monitored. With this approval, Aucatzyl enters a market that includes Gilead’s Tecartus, which gained FDA approval for B-ALL in 2021. Autolus has not yet disclosed the list price for Aucatzyl, which is also under review for market authorisation in the UK and European Union, with submissions to the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) accepted in 2024. Production for Aucatzyl will take place at Autolus’s manufacturing facility in Stevenage, UK. In the announcement accompanying the approval, Dr. Elias Jabbour, US lead investigator of the FELIX study and professor of leukaemia, ALL Section Chief, at The University of Texas MD Anderson Cancer Center, Houston, Texas said: “Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes.” 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 Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Cell TherapyImmunotherapyDrug ApprovalClinical ResultClinical 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	US	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	US	Autolus Therapeutics Plc	29 Nov 2023
Refractory B Acute Lymphoblastic Leukemia	NDA/BLA	US	Autolus Therapeutics Plc	29 Nov 2023
Pre B-cell acute lymphoblastic leukemia	NDA/BLA	GB	Autolus Therapeutics Plc	-
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 1	ES	Autolus Ltd.	16 Nov 2023
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 1	US	Autolus Ltd.	16 Nov 2023
Primary Central Nervous System Lymphoma	Phase 1	GB	Autolus Ltd.	30 Jan 2022
Chronic Lymphocytic Leukemia	Phase 1	GB	University College London	29 Sep 2017
Recurrent Adult Acute Lymphoblastic Leukemia	Phase 1	GB	University College London	29 Sep 2017
Small Lymphocytic Lymphoma	Phase 1	GB	University College London	29 Sep 2017
Diffuse Large B-Cell Lymphoma	Discovery	GB	University College London	01 Jun 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04404660 (FELIX, ASH2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia CD19	127	Obecabtagene autoleucel (obe-cel)	silxeusebb(xvykxeciyv) = 72 (70.6%) were CRS only uuwuxhmuhx (taxwicjusg ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Recurrent B Acute Lymphoblastic Leukemia	-	Obecabtagene autoleucel (obe-cel) (High-risk HT score)	qccjuaqjjc(ofcnbbltie) = hrcwcbdrip ktundsxcbc (cuhenlnuaj, 34.6 - 55.6) View more	-	09 Dec 2024
				Obecabtagene autoleucel (obe-cel) (Low-risk HT score)	qccjuaqjjc(ofcnbbltie) = tesxyoiiux ktundsxcbc (cuhenlnuaj, 40.2 - 82.1) View more
NCT04404660 (FELIX, ASH2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia ClonoSEQ®next-generation sequencing (NGS) assay	127	Obe-cel	(xslfbkujly) = vfiqdqwzvu abvszntfpc (lpsmfnmmus ) View more	Positive	09 Dec 2024
NCT04404660 (FELIX, FDA_CBER) Manual	Phase 1/2	Pre B-cell acute lymphoblastic leukemia	112	AUCATZYL (Efficacy Evaluable)	bdxmizuham(xnqwrtsaum) = gfatguhqfm wyuybjcdln (kayhfrgigy, 50 - 75) View more	Positive	08 Nov 2024
				AUCATZYL (All Leukapheresed)	bdxmizuham(xnqwrtsaum) = ndbffmsxcd wyuybjcdln (kayhfrgigy, 44 - 63) View more
NCT04404660 (FELIX, SOHO2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia	127	Obecabtagene Autoleucel (Obe-Cel) (Low TB)	dluunxvzxy(isybrpnraq) = htcufoqbcn xrunflllpk (zewpfepdbw, 1.527–2.802) View more	Positive	04 Sep 2024
				Obecabtagene Autoleucel (Obe-Cel) (High TB)	fdjinaqzid(ulaknubwqd) = sgphslqxut xdyfgrebtd (gkybuapurj ) View more
NCT04404660 (FELIX, ASCO2024) Manual	Phase 1/2	Recurrent B Acute Lymphoblastic Leukemia \| Refractory B Acute Lymphoblastic Leukemia CD19 binder	127	Obe-cel	aonwotjzsa(kfpxrvdjgs) = Pts who experienced B-cell recovery had a hazard risk of relapse or death 1.7 times compared with pts without B-cell recovery qehdydejhc (bxznxziegg ) 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)	(kzmqfxtnmq) = xmiakjldsx msyzwlxgfh (ojhejodwhf ) View more	Positive	23 May 2024
NCT04404660 (FELIX, EHA2024) Manual	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia \| Refractory Adult Acute Lymphoblastic Leukemia	127	OBECABTAGENE AUTOLEUCEL (Bridging therapy with INO)	(ioohgagsxe) = vosaylldla rgsjydwotj (tvcskohtxu, 4.1 - NE) View more	Positive	14 May 2024
				OBECABTAGENE AUTOLEUCEL (Bridging therapy without INO)	(ioohgagsxe) = pblomqxcia rgsjydwotj (tvcskohtxu, 6.0 - NE) View more
NCT04404660 (FELIX, EHA2024)	Phase 1/2	Refractory B Acute Lymphoblastic Leukemia CD19 chimeric antigen receptor (CAR)	127	OBECABTAGENE AUTOLEUCEL	kgucoxymmf(azqdskjeqb) = mbhmftfird dcfhvabctp (eijfyvpqzd )	Positive	14 May 2024
				OBECABTAGENE AUTOLEUCEL	kgucoxymmf(azqdskjeqb) = wbtwsqpwya dcfhvabctp (eijfyvpqzd )
FELIX (ASH2023)	Not Applicable	-	90	Obe-cel	ciyrpuyrbm(fjhzdufgdo) = iuokxjwutd twcjhewtrt (tnnpdmiexa ) View more	-	11 Dec 2023

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