NCT04888442

Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL

A Phase I Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in adults with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.

Detailed description

This is a single-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 adults with relapsed or refractory B-ALL.pCAR-19B will be infused to the subject by intravenous infusion.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	pCAR-19B cells	Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Timeline

• Start date: 2020-10-26
• Primary completion: 2022-01-30
• Completion: 2022-03-28
• First posted: 2021-05-17
• Last updated: 2021-05-17

Locations

1 site across 1 country: China