NCT06179524

CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL

Phase II Clinical Study of CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/refractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (inclusive)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beijing Yongtai Ruike Biotechnology Company Ltd · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.

Detailed description

This is a multiple-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of CD19 CAR T-cells at a target dose of 2.5 x10\^6 cells/kg（range 0.8-2.5×10\^6 cells/kg）.

Conditions

• Relapsed B-cell Acute Lymphoblastic Leukemia
• Refractory B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T-19 cell injection	The functional component of CAR-T-19 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-06-30
• Completion: 2027-04-30
• First posted: 2023-12-22
• Last updated: 2025-01-13

Locations

1 site across 1 country: China