NCT06142175

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 28, 2024

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 15, 2023

Last Update Submit

March 27, 2024

Conditions

Large B-cell Lymphoma

Keywords

Relmacabtagene AutoleucelChimeric antigen receptor T cells

Outcome Measures

Primary Outcomes (1)

  • ORR

    Percentage of participants with CR or PR

    6 months

Secondary Outcomes (5)

  • CRR

    6 months

  • DOR

    6 months

  • Progression-Free Survival (PFS)

    6 months

  • Overall Survival (OS)

    6 months

  • Adverse events (AEs)

    6 months

Study Arms (1)

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

Interventions

Relmacabtagene AutoleucelBIOLOGICAL

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

Also known as: JWCAR029
Relmacabtagene Autoleucel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

r/r LBCL

You may qualify if:

  • Adult patients with established r/r LBCL;
  • Patients already treated with commercially available Relmacabtagene Autoleucel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Interventions

relmacabtagene autoleucel

Study Officials

  • 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

    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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical JWCAR029, PhD

CONTACT

+86 21 50464201JWCAR029Medical@jwtherapeutics.com

Weili Zhao, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

December 28, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 28, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)