drugset
drugset / Trial / NCT05727683

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

NCT05727683 ↗

Phase 1 Unknown 33 enrolled Shanghai Ming Ju Biotechnology Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Relmacabtagene Autoleucel Cell therapy 100000 cells/kg —
Subject Relmacabtagene Autoleucel Cell therapy 300000 cells/kg —
Subject Relmacabtagene Autoleucel Cell therapy 750000 cells/kg —
Subject Relmacabtagene Autoleucel Cell therapy 1e+06 cells/kg —
Background Cyclophosphamide Other / unclassified 250 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous

Indications

acute lymphoblastic leukemia