Relmacabtagene Autoleucel in Patients With LBCL

Shanghai Ming Ju Biotechnology

Status: Enrolling

Conditions: Large B-cell Lymphoma

Treatments: Biological: Relmacabtagene Autoleucel

Study type: Observational

Funder types: Industry

Identifiers

NCT06142175

JWCAR029-008

Details and patient eligibility

About

To evaluate the efficacy and safety of Relmacabtagene autoleucel for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) in real-world

Full description

This is a post-marketing, multicenter, observational real-world study, including prospective and retrospective studies. The purpose of this study is to collect efficacy and safety data over a 6-month period following treatment of adult patients with r/r LBCL with Relmacabtagene autoleucel. The treating physicians in the study will determine the most appropriate diagnostic and therapeutic regimen for their patients based on clinical practice.There will be no therapeutic intervention as a result of this study. There will be no subgroups of any kind in this study, and subgroup analyses will be performed based on the actual data collected during the analysis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients with established r/r LBCL;
2. Patients already treated with commercially available Relmacabtagene Autoleucel

Exclusion criteria

No

Trial design

200 participants in 1 patient group

Relmacabtagene Autoleucel

Description:

Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10\^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.

Treatment:

Biological: Relmacabtagene Autoleucel