Relmacabtagene Autoleucel in Patients With LBCL
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | 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:
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Outcome Measures
Primary Outcome Measures
- ORR [6 months]
Percentage of participants with CR or PR
Secondary Outcome Measures
- CRR [6 months]
Complete response rate
- DOR [6 months]
Duration of response
- Progression-Free Survival (PFS) [6 months]
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.
- Overall Survival (OS) [6 months]
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
- Adverse events (AEs) [6 months]
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients with established r/r LBCL;
-
Patients already treated with commercially available Relmacabtagene Autoleucel
Exclusion Criteria:
No
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Shanghai Ming Ju Biotechnology Co., Ltd.
Investigators
- Principal Investigator: Weili Zhao, PhD, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
- Principal Investigator: Huiqiang Huang, PhD, Sun Yat-sen University
- 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: Hongmei Jing, Peking University Third Hospital
- Principal Investigator: Wenbin Qian, Second Affiliated Hospital, School of Medicine, Zhejiang University
- Principal Investigator: Depei Wu, The First Affiliated Hospital of Soochow University
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- JWCAR029-008