Relmacabtagene Autoleucel in Patients With LBCL

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

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

Study Overview

• Status: Recruiting
• Conditions: Large B-cell Lymphoma
• Intervention / Treatment: Biological: Relmacabtagene Autoleucel

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Medical JWCAR029, PhD; Phone Number: +86 21 50464201; Email: JWCAR029Medical@jwtherapeutics.com
• Study Contact Backup: Name: Weili Zhao, PhD

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
      • Contact: Weili Zhao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

r/r LBCL

Description

Inclusion Criteria:

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

Exclusion Criteria:

No

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Relmacabtagene Autoleucel; 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.	Biological: Relmacabtagene Autoleucel; A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells; Other Names: JWCAR029

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Percentage of participants with CR or PR	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRR	Complete response rate	6 months
DOR	Duration of response	6 months
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
Overall Survival (OS)	OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.	6 months
Adverse events (AEs)	Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter	6 months

Collaborators and Investigators

• Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Depei Wu, The First Affiliated Hospital of Soochow University; Principal Investigator: Huiqiang Huang, PHD, Sun Yat-sen University; Principal Investigator: WenBin Qian, Second Affiliated Hospital, School of Medicine, Zhejiang University; Principal Investigator: Hongmei Jing, Peking University Third Hospital; Principal Investigator: Weili Zhao, PhD, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,; Principal Investigator: Liang Huang, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China; Principal Investigator: Ping Li, Shanghai Tongji Hospital, Tongji University School of Medicine; Principal Investigator: Heng Mei, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China; Principal Investigator: Ying Lu, Ningbo University People's Hospital; Principal Investigator: Huilai Zhang, Tianjin Cancer Hospital; Principal Investigator: Qingyuan Zhang, Harbin Medical University Tumor Hospital; Principal Investigator: Dehui Zou, Hematology hospital, Chinese academy of medical sciences; Principal Investigator: Yao Liu, Chongqing University Cancer Hospital; Principal Investigator: Jianqiu Wu, Jiangsu Provincial Tumor Hospital; Principal Investigator: Yajun Li, Hunan Cancer Hospital; Principal Investigator: Ru Feng, Southern Medical University, China; Principal Investigator: Yuhua Li, Nanfang Hospital, Southern Medical University; Principal Investigator: Zhifeng Li, The First Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Chimeric antigen receptor T cells; Relmacabtagene Autoleucel
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: JWCAR029-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No