NCT06343090

Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients

Pragmatic Clinical Trial of CD19 and CD22 CAR T-cell Sequential Therapy Versus Single CD19 CAR T-cell Bridging to Transplantation for Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 353 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.

Conditions

• B-cell Acute Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia, in Relapse
• Refractory Acute Lymphoid Leukemia

Interventions

Type	Name	Description
DRUG	CD19 CAR T-cell	Murine-derived CD19 CAR T cells
DRUG	CD22 CAR T cells	humanized CD22 CAR T cells
PROCEDURE	hematopoietic stem-cell transplantation	allo-HSCT

Timeline

• Start date: 2024-04-12
• Primary completion: 2042-12-01
• Completion: 2043-09-30
• First posted: 2024-04-02
• Last updated: 2026-03-10

Locations

1 site across 1 country: China