Relmacabtagene Autoleucel in Patients With LBCL

NCT ID: NCT06142175

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-28

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Large B-cell Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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.

Relmacabtagene Autoleucel

Intervention Type BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Interventions

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Relmacabtagene Autoleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Intervention Type BIOLOGICAL

Other Intervention Names

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JWCAR029

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

No
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Ming Ju Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weili Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Huiqiang Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Liang Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China

Ping Li

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Heng Mei

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hongmei Jing

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Wenbin Qian

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Depei Wu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Ying Lu

Role: PRINCIPAL_INVESTIGATOR

Ningbo University People's Hospital

Huilai Zhang

Role: PRINCIPAL_INVESTIGATOR

Tianjin Cancer Hospital

Qingyuan Zhang

Role: PRINCIPAL_INVESTIGATOR

Harbin Medical University Tumor Hospital

Dehui Zou

Role: PRINCIPAL_INVESTIGATOR

Hematology Hospital, Chinese Academy of Medical Sciences

Yao Liu

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Jianqiu Wu

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Tumor Hospital

Yajun Li

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Ru Feng

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Yuhua Li

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Zhifeng Li

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Xiamen University

Locations

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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Medical JWCAR029, PhD

Role: CONTACT

+86 21 50464201

Weili Zhao, PhD

Role: CONTACT

Facility Contacts

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Weili Zhao, PhD

Role: primary

Other Identifiers

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JWCAR029-008

Identifier Type: -

Identifier Source: org_study_id

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