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

NCT04888442 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-05-17

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 adults with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.

Conditions

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

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
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2022-01-30
Completion
2022-03-28

Countries

  • China

Study Locations

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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 NCT04888442 on ClinicalTrials.gov