NCT06834529

CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma

Safety and Efficacy of CAR2219 CAR-T Cells in Treatment of Relapsed/refractory CD19/CD22 Positive B Cell Leukemia and Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma.

Detailed description

This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR2219 CAR-T cell. 20 subjects with relapsed or refractory CD19/ CD22 positive B-cell Leukemia and Lymphoma will be enrolled and received CAR2219 CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy.

Conditions

• Relapsed or Refractory B Cell Leukemia and Lymphoma

Interventions

Type	Name	Description
GENETIC	CAR2219-T cells	Genetic: CAR2219-T cells Each subject will be infused with single dose of CD2219-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 5×10\^5 /kg, the medium dose is 1×10\^6 /kg, and the high dose is 2×10\^6 /kg. Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.

Timeline

• Start date: 2025-01-20
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

1 site across 1 country: China