NCT06559189

CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 3 Months – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 Interval (BOIN) design. This trial will enroll up to 53 patients with 21 patients in each cohort receiving treatment with lymphodepleting chemotherapy followed by CD19x22 CAR T cell infusion, with a total of up to 42 treated patients overall. Patients will be assessed for dose limiting toxicities (up to 28 days from infusion) to determine a maximum tolerated dose (MTD) and for preliminary efficacy through morphological remission rate and measurable residual disease (MRD) levels.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19x22 CAR T	The investigational product is an autologous, genetically modified CD19xCD22 CAR T cell product produced by the Gates Biomanufacturing Facility.

Timeline

• Start date: 2024-09-27
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2024-08-19
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study