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)
University of Colorado, Denver
Summary
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.
Description
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 Inter…
Eligibility
- Age range
- 0–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects must have a history of B precursor ALL with any of the following conditions: 1. Relapsed two or more times. 2. Relapsed at any time after allogeneic bone marrow transplant (BMT). 3. 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 eva…
Interventions
- BiologicalCD19x22 CAR T
The investigational product is an autologous, genetically modified CD19xCD22 CAR T cell product produced by the Gates Biomanufacturing Facility.
Location
- Children's Hospital ColoradoAurora, Colorado