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Obecabtagene Autoleucel for B-cell Acute Lymphoblastic Leukemia

This study is investigating if obecabtagene autoleucel (obe-cel) is an effective treatment for people aged 40 and older with B-cell acute lymphoblastic leukemia (ALL). You may be able to join if your ALL is in complete remission (CR, meaning all signs of cancer are gone) and you have no measurable residual disease (MRD-negative, meaning no detectable cancer cells) for the first time. Obecabtagene autoleucel is a type of drug that works by targeting specific mechanisms in the body, like kinase inhibitors and tyrosine kinase. The main goal is to see how long people stay free from relapse (relapse-free survival) one year after receiving the infusion. The study plans to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.
What's involved
You would receive obecabtagene autoleucel as an infusion, given 3 days (plus or minus 1 day) after completing lymphodepleting chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Your relapse-free survival will be measured at 1 year from the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07400029

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

Recruiting
PHASE2Ages 40+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~40 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Obecabtagene Autoleucel

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
relapse free survival (RFS) (Cohort A)
Measured over 1 year from infusion

Conditions

Acute Lymphoblastic Leukemia

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Where it's being run

9 sites across 3 states
New York4
New Jersey3
California2

Study leadership

  • Ioannis Kalogirou Valtis, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Ioannis Kalogirou Valtis, MD
[email protected]
646-608-2091
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 \<10\^-4 will be eligible.
Patients may receive more than one course of upfront induction and/or consolidation, but must be in MRD- CR/CRi at time of screening, within 4 months from initiation of treatment. The 4-month window will be measured from the first day of anti-leukemic therapy initiation (excluding steroid prophase) until the Screening A test for the trial.
HyperCVAD or mini-hyper-CVD
Asparaginase-containing multiagent chemotherapy (e.g. CALGB10403, pediatric inspired chemo)
Inotuzumab or blinatumomab with or without chemotherapy
Tyrosine kinase inhibitor plus steroids, chemotherapy, or blinatumomab
ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)
Serum creatinine \<2.0mg/dL
SaO2 ≥92% on room air
Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening
ECOG performance status 0-2
CD19 expression is required at any time since diagnosis. CD19 expression may be detected by immunohistochemistry or by flow cytometry. Patients receiving prior blinatumomab are eligible if there is no documentation of CD19-negative disease after blinatumomab.
CNS1 status must be documented at time of screening by CSF assessment. Patients with prior CNS2 or CNS3 disease must be CNS1 at screening and have no residual CNS deficits or symptoms.
Patients will need to adhere to institutional contraception guidelines for a minimum of 1 year.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion

Burkitt's leukemia or lymphoma
Patients with measurable extramedullary disease at screening are excluded. Patients with prior history of extramedullary disease are allowed after documentation of disease resolution by either PET/CT scan (or CT with contrast if PET cannot be performed).
The following medications are excluded:
Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.
Systemic chemotherapy: Must be discontinued 7 days prior to leukapheresis or 7 days prior to starting lymphodepleting chemotherapy if used during bridging.
Tyrosine kinase inhibitors: Must be discontinued 48 hours prior to apheresis and 48 hours prior to starting lymphodepleting chemotherapy, if used during bridging.
Blinatumomab must be discontinued 5 days before apheresis
Inotuzumab must be discontinued 2 weeks before apheresis to allow T cell recovery
Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion
Blinatumomab may not be used as bridging therapy following apheresis
Positive test indicating the presence of active infection with the following pathogens: HIV, Hepatitis B (detectable Hep B DNA by PCR or Hep B surface antigen), Hepatitis C (detectable Hep C RNA by PCR), HTLV, Syphilis. The tests required will be agreed upon with the manufacturer to comply with manufacturer's regulatory and manufacturing requirements.

What this trial measures

  • relapse free survival (RFS) (Cohort A)1 year from infusion

    The time from CAR T infusion until non-response, relapse, or death of any cause, censored at last follow up. Non-response will be defined as the presence of \> 5% abnormal lymphoblasts in the bone marrow, or the presence of unequivocal CNS or extramedullary disease after obe-cel infusion. Relapse will be defined as the emergence of \> 5% abnormal lymphoblasts in the bone marrow, or the emergence of new unequivocal CNS or extramedullary disease after obe-cel infusion. Patients will be censored for relapse free survival if they undergo allogenic stem cell transplant or receive any other new treatment (except start or change of TKI maintenance) while in remission.