RecruitingPhase 2NCT07400029

A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia

A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

40 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia

Summary

The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing obecabtagene autoleucel (obe-cel), a CAR-T cell therapy where a patient's own immune cells are taken from their blood, genetically engineered to attack a specific protein (CD19) on leukemia cells, and then reinfused — for adults with B-cell acute lymphoblastic leukemia (ALL) who are in remission or have measurable minimal residual disease (MRD). **You may be eligible if...** - You are 30 or older (patients aged 30–39 may need additional qualifying factors) - You have been diagnosed with CD19-positive B-cell ALL - Your leukemia has detectable disease in the bone marrow (by sensitive lab testing) - You have responded partially to prior therapy but still have residual cancer detectable **You may NOT be eligible if...** - You have active, uncontrolled infection - You have severe organ dysfunction (heart, liver, kidney) - You have had a prior allogeneic (donor) stem cell transplant recently - You are pregnant or breastfeeding - You have CNS (brain or spinal cord) leukemia that is not controlled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObecabtagene Autoleucel

Given as infusion. Obe-cel dose 1: Obe-cel will be administered 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy, allowing a minimum of 48 hour washout from the last dose of lymphodepleting chemotherapy.