MedTrace Logo

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

NCT04888468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-03-18

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

pCAR-19B cells

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

Sponsors & Collaborators

  • Chongqing Precision Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jianfeng Zhou, M.D. Ph.D · Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2021-06-29
Completion
2021-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04888468 on ClinicalTrials.gov