Study on Obecabtagene Autoleucel for People with B-cell Acute Lymphoblastic Leukemia

Inclusion Criteria

• Diagnosed with CD19+ B-cell acute lymphoblastic leukemia (ALL).
  • Both Ph-negative and Ph-positive types are allowed.
  • If there is disease outside the bone marrow, it must be detectable in the bone marrow.
• Aged 40 years or older at the time of screening.
• Aged 30-39 years with high-risk health conditions or poor tolerance to chemotherapy.
• In complete remission with no detectable cancer cells (MRD-negative) at the time of screening.
• May have received more than one course of initial treatment but must be in MRD-negative remission within 4 months of starting treatment.
• Must have adequate organ function, including:
  • Liver enzymes (ALT or AST) ≤5 times the normal limit and bilirubin ≤2 (or ≤3 with certain conditions).
  • Serum creatinine <2.0 mg/dL.
  • Oxygen saturation ≥92% on room air.
  • Heart function (LVEF) ≥50% within 1 month of screening.
• ECOG performance status of 0-2.
• CD19 expression must be confirmed at any time since diagnosis.
• No active central nervous system (CNS) disease at screening.
• Must follow contraception guidelines for at least 1 year.

Exclusion Criteria

• Have another active cancer, except for non-melanoma skin cancer.
• Have Burkitt's leukemia or lymphoma.
• Have measurable disease outside the bone marrow at screening.
• Cannot use certain medications close to treatment, including:
  • High-dose steroids within 7 days of cell collection or 72 hours before CAR T cell infusion.
  • Systemic chemotherapy within 7 days of cell collection or starting lymphodepleting chemotherapy.
  • Tyrosine kinase inhibitors within 48 hours of cell collection or starting lymphodepleting chemotherapy.
  • Blinatumomab within 5 days of cell collection.
  • Inotuzumab within 2 weeks of cell collection.
• Have uncontrolled infections at the time of cell collection or CAR T cell infusion.
• Cannot use blinatumomab as bridging therapy after cell collection.
• Positive test for active infections like HIV, Hepatitis B, Hepatitis C, HTLV, or Syphilis.