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)
The primary objective of this Phase I open-label study is to assess the safety and tolerability of CD19x22 CAR T cells in pediatric patients with R/R B-ALL.
Why this Research Matters
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
Study ID
Protocol Number: 22-0998
More information available at ClinicalTrials.gov: NCT06559189
Meet the Team
Principal Investigator