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CD19-targeted CAR T Cells for Patients With Relapsed or Refractory in B-cell Acute Lymphoblastic Leukemia

NCT05727683 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-02-14

No results posted yet for this study

Summary

This is a phase I, open-label, single-arm study conducted in China to evaluate the safety, tolerability, PK, and determine the recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD) (if applicable) of JWCAR029 in pediatric and young adult subjects with r/r B-ALL.

Conditions

  • Acute Lymphocytic Leukemia

Interventions

BIOLOGICAL

CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

Subjects will receive Lymphodepleting chemotherapy with intravenous (IV) fludarabine (25 mg/m2/day for 3 days) plus cyclophosphamide IV (250 mg/m2/day for 3 days) (flu/cy) concurrently, followed by JWCAR029 cells infusion. Phase 1 will evaluate up to 4 JWCAR029 cells dose levels.

Sponsors & Collaborators

  • Shanghai Ming Ju Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaofan Zhu, PhD · Hematology Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-10-31
Completion
2025-07-31

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 NCT05727683 on ClinicalTrials.gov