CD19x22 CAR T

The investigational product is an autologous, genetically modified CD19xCD22 CAR T cell product produced by the Gates Biomanufacturing Facility.

This is an open-label Phase I trial consisting of 2 cohorts to determine the safety and tolerability of CD19x22 CAR T in Pediatric Patients with R/R B-ALL.

This trial will include two parallel cohorts based on disease burden prior to lymphodepleting chemotherapy, Cohort 1: high disease burden cohort: defined as \>=25% bone marrow lymphoblasts and/or non-CNS extramedullary disease, and Cohort 2: low disease burden cohort: defined as \<25% bone marrow lymphoblasts and no non-CNS extramedullary disease. Dose escalation will proceed independently within each cohort using the Bayesian Optimal Interval (BOIN) design.

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.

Live record on ClinicalTrials.gov →

• 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.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.