NCT05270772

CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL

A Single-arm, Open-label Phase I Study of CAR-T-19 (Anti CD19 scFv Chimeric Antigen Receptor T) Cells for Patients With CD19-positive Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia Under The Age of 25

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.

Detailed description

B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25. Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.

Conditions

• CD19+ Relapse/Refractory B-ALL

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T-19 Cells	T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10\^6/kg,1.5×10\^6/kg, 5.0×10\^6/kg CAR+ cells.

Timeline

• Start date: 2021-02-25
• Primary completion: 2022-07-15
• Completion: 2024-09-16
• First posted: 2022-03-08
• Last updated: 2022-03-08

Locations

1 site across 1 country: China