This Phase I trial aims to determine the safety and tolerability of bispecific CD19x22 CAR T cell administration after lymphodepleting chemotherapy in pediatric patients with R/R B-ALL.

Who can Participate

1. Subjects must have a history of B precursor ALL with any of the following conditions: a. Relapsed two or more times. b. Relapsed at any time after allogeneic BMT. c. Relapse or refractory after single antigen targeting CAR T cell therapy. 1. Subjects must have a history of B precursor ALL with any of the following conditions: a. Relapsed two or more times. b. Relapsed at any time after allogeneic BMT. c. 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. 2. CD19 and/or CD22 present on last relapsed/refractory disease evaluation. 3. Performance score (Lansky or Karnofsky ≥ 50%; or ECOG must be ≤2). 4. Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines. 5. Males OR non-pregnant, non-lactating females. 6. Aged 3 months to 30 years (inclusive) at time of consent and enrollment. 7. 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 (Section 8.1.2). 8. Stated willingness to comply with all study procedures and be available for the duration of the study. 9. Willingness to participate in long-term follow-up protocol (20-0188).

Study ID

More information available at ClinicalTrials.gov: NCT06559189