NCT05590221

Relmacabtagene Autoleucel as First-Line Therapy for High-Risk Large B-Cell Lymphoma

Study to Evaluate the Efficacy and Safety of Relmacabtagene Autoleucel (Relma-cel) as First-Line Therapy in Adult Participants With High-Risk Large B-Cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to estimate the efficacy of Relmacabtagene Autoleucel in participants with high-risk large B-cell lymphoma.

Detailed description

This is a prospective, open-label, multicenter, single-arm trial, assessed the efficacy and safety of JWCAR029(relma-cel) as part of first-line therapy after an incomplete first-line treatment regimen of two cycles of chemoimmunotherapy. High-risk LBCL was defined by the dynamic risk assessment of interim PET2+, together with either double- or triple-hit lymphomas or high-intermediate- and high-risk IPI scores (≥3). All sujects will be followed for 2 years following JWCAR029 infusion.

Conditions

• B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Relmacabtagene Autoleucel	A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
DRUG	Fludarabine	Administered according to package insert
DRUG	Cyclophosphamide	Administered according to package insert

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-02-10
• Completion: 2024-12-10
• First posted: 2022-10-21
• Last updated: 2024-01-08

Locations

4 sites across 1 country: China