CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04812691
NCT04812691Phase 1Completed

CD19-targeted CAR T Cells (JWCAR029) for Primary Refractory Diffuse Large B Cell Lymphoma, Phase Ⅰ,Open-label,Single-arm,Muticenter Study

Shanghai Ming Ju Biotechnology Co., Ltd.·interventional·Posted Mar 24, 2021·Updated Nov 22, 2023

In Brief

A Phase 1 clinical trial evaluating JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells) for Diffuse Large B Cell Lymphoma. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedMar 24, 2021
Enrollment StartJul 10, 2020
Primary CompletionJun 30, 2021
Study CompletionApr 25, 2023
TodayJul 1, 2026
Enrollment to primary: 12 monthsPosted 5.3 years ago

Interventions

JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)biological

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive 1 x 10\^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.