Relmacabtagene Autoleucel in Patients With LBCL

Large B-cell Lymphoma Clinical Trial

Official title:

A Real World Study of Treatment of Relmacabtagene Autoleucel in Relapsed or Refractory Large B-Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142175
• Other study ID #: JWCAR029-008
• Status: Recruiting
• Start date: December 28, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Shanghai Ming Ju Biotechnology Co., Ltd.
• Contact: Medical JWCAR029, PhD
• Phone: +86 21 50464201
• Email: JWCAR029Medical[@]jwtherapeutics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients with established r/r LBCL;

2. Patients already treated with commercially available Relmacabtagene Autoleucel

Exclusion Criteria:

No

Related Conditions & MeSH terms

• Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• Relmacabtagene Autoleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ming Ju Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Percentage of participants with CR or PR	6 months
Secondary	CRR	Complete response rate	6 months
Secondary	DOR	Duration of response	6 months
Secondary	Progression-Free Survival (PFS)	PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.	6 months
Secondary	Overall Survival (OS)	OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.	6 months
Secondary	Adverse events (AEs)	Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter	6 months