Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Pediatric Patients With Relapsed and/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)
This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.
• Subjects must have a history of B precursor ALL with any of the following conditions:
‣ Relapsed two or more times.
⁃ Relapsed at any time after allogeneic bone marrow transplant (BMT).
⁃ Relapse or refractory after single antigen targeting CAR T cell therapy.
• i. 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and/or parents declining BMT options and would prefer CAR T Therapy.
• CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
• Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).
• Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.
• Males OR non-pregnant, non-lactating females.
• Aged 3 months to 30 years (inclusive) at time of consent and enrollment.
• Provision of a signed and dated consent form from parent or guardian (patients \< 18), the patient themselves (\> 18), or legally authorized representative (patient \> 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Willingness to participate in long-term follow-up protocol.