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Recruiting NCT07400029

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

Conditions: Acute Lymphoblastic Leukemia

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Memorial Sloan Kettering Cancer Center

Location: Stanford University (Data Collection AND Specimen Analysis) Stanford California

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 Criteria

Inclusion Criteria: * Diagnosis of CD19+ B-cell ALL. * Both Ph-negative and Ph-positive are allowed * Patients with EMD must have detectable disease in the bone marrow (by flow cytometry or molecular methods) in order to follow MRD. * Patients aged ≥ 40 years at time of screening A. * Patients aged 30-39 years (at time of Screening A) are allowed in the presence of high-risk comorbidities or poor tolerability of chemotherapy (e.g. history or experienced pancreatitis with therapy, BMI ≥40kg/m2, underlying liver disease precluding safer administration of pediatric inspired regimens, any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric or pediatric-inspired standard chemotherapy regimen). * In MRD negative CR or CR with incomplete hematologic recovery (CRi) at the time of screening. MRD will be assessed by flow cytometry and/or molecular testing such as ClonoSEQ at the minimum sensitivity of 10-4 from the bone marrow. Patients with MRD \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07400029). StuddyBuddy aggregates publicly available trial information.