NCT04812691

CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment. One dose level of 1.0 x 10\^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after JWCAR029 infusion.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)	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.

Timeline

• Start date: 2020-07-10
• Primary completion: 2021-06-30
• Completion: 2023-04-25
• First posted: 2021-03-24
• Last updated: 2023-11-22

Locations

2 sites across 1 country: China