NCT05727683

A Phase I Open, Single-arm Study of JWCAR029 (CD19-targeted Chimeric Antigen Receptor T Cells) for Patients With Relapsed or Refractory in B-cell Acute Lymphoblastic Leukemia

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.

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Interventions

CD19-targeted Chimeric Antigen Receptor (CAR) T CellsBIOLOGICAL
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.

Study Locations

FacilityCityStateCountry
Hematology Hospital, Chinese Academy of Medical SciencesTianjinTianjin MunicipalityChina

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026