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

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 \<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.
• •Frontline regimens include but are not limited to:
• •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
• •\- Adequate organ function at time of screening A, including:
• •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
• •* 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