NCT05727683

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Dose exploration for this study will be a 3+3 design with a target DLT rate of \<1/3. Dose exploration can be discontinued once one or more dose levels with an acceptable safety profile and satisfactory antitumor activity have been selected for subsequent evaluation. The maximum tolerated dose (MTD) may not be achieved at the dose levels predetermined in this study as described below. During the treatment period of the study, four dose levels of JWCAR029 will be evaluated. enrollment will begin at dose level 1, follow a 3+3 dose exploration design protocol, and finally select one or more dose levels with an acceptable safety profile and good antitumor activity as the recommended dose, after which dose exploration will be discontinued. Dose limiting toxicity (DLT) will be evaluated within 28 days after JWCAR029 infusion. Each dose cohort is planned to enroll three subjects initially, and at least one pediatric subject younger than 10 years of age who can be evaluated for DLT will be enrolled at each dose level. In the first dose cohort, the first 3 subjects will be infused at least 14 days apart. At each higher dose level, the first 3 patients within the dose cohort will be treated at least 7 days apart. For dose levels considered safe, at least 3 subjects with assessable DLT must complete a 28-day DLT assessment period.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-10-31
• Completion: 2025-07-31
• First posted: 2023-02-14
• Last updated: 2023-02-14

Locations

1 site across 1 country: China