NCT05309213

Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia

A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	IM19 CAR-T cells	IM19 CAR-T cells will be administered at dose level:5 x 10\^4 CAR+ T cells/kg,1x 10\^5 CAR+ T cells/kg,3 x 10\^5 CAR+ T cells/kg,1 x 10\^6 CAR+ T cells/kg

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-04-01
• Completion: 2025-06-01
• First posted: 2022-04-04
• Last updated: 2022-04-04