NCT04603872

CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies

Clinical Trial for the Safety and Efficacy of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.

Detailed description

This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory
• Acute Lymphoblastic Leukemia, in Relapse
• Acute Lymphocytic Leukaemia Refractory
• Non-Hodgkin's Lymphoma, Relapsed
• Non-Hodgkin's Lymphoma Refractory

Interventions

Type	Name	Description
DRUG	CD19/BCMA Targeted CAR T-cells and dasatinib	Each subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens.
DRUG	CD19/BCMA Targeted CAR T-cells	Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-11-01
• Completion: 2026-11-01
• First posted: 2020-10-27
• Last updated: 2020-10-28

Locations

1 site across 1 country: China