NCT06149169

CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma

An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed and Refractory (R/R) LBCL

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.

Detailed description

This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment. Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10\^8 CAR+T cells.The indication for this application is R/R LBCL(supplement study) and the recommended dose is 1×10\^8 CAR+T cells.

Conditions

• Lymphoma, Non-Hodgkin
• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19-targeted Chimeric Antigen Receptor(CAR) T Cells	Relma-cel be administered at one dose level:1×10\^8 CAR+T cells

Timeline

• Start date: 2023-08-17
• Primary completion: 2024-10-30
• Completion: 2025-03-31
• First posted: 2023-11-28
• Last updated: 2024-08-21

Locations

1 site across 1 country: China