NCT06641024

Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL

Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Relapsed/Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia (B-ALL)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic Leukemia.

Detailed description

Based on the specific CD19-targeting CAR-T developed on the PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs. At the same time, MC-1-50 products have a high proportion of T naive cells, which can play a therapeutic effect at a very low infusion dose to improve safety. In this study, a \"3+3\" design was adopted, and three dose groups were set up with 1×10\^5/kg, 3×10\^5/kg, and 5×10\^5/kg CAR-positive cells, respectively (the upper limit of the total number of cells was not more than 5×10\^7 CAR-positive cells). All subjects received only one infusion of MC-1-50 cells.

Conditions

• Acute Lymphoblastic Leukemia, in Relapse
• Refractory Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	MC-1-50	A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-11-01
• Completion: 2039-11-01
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China