Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

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.

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

Relmacabtagene Autoleucel

Medical JWCAR029, PhD

Weili Zhao, PhD

Huiqiang Huang, PhD

Liang Huang, PhD

Ping Li

Heng Mei

Hongmei Jing

Wenbin Qian

Depei Wu

Ying Lu

Huilai Zhang

Qingyuan Zhang

Dehui Zou

Yao Liu

Jianqiu Wu

Yajun Li

Ru Feng

Yuhua Li

Zhifeng Li

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

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.

Relmacabtagene Autoleucel in Patients With LBCL

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

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.

OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.

Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter

Shanghai Ming Ju Biotechnology Co., Ltd.

Behaviors and Mental Disorders

Nervous System Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Follicular

Aggression

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Experimental: Relmacabtagene Autoleucel Participants will receive cyclophosphamide250 mg/m\^2/day intravenously (IV) and fludarabine 25 mg/m\^2/day IV conditioning chemotherapy for 3 days followed by 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.

Qingqing Cai

Keshu Zhou

Mingzhi Zhang

Hui Zhou

Depei Wu, PhD

Dehui Zou, PhD

Jie Jin

Liang Wang

Wei Zhang

Huayuan Zhu

The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.

This is an open-label, multicenter, Phase 2 study to determine the antitumor activity, PK, and safety of JWCAR029(Relmacabtagene autoleucel ) in subjects who have relapsed within 12 months from, or are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.

Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL

Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL: a Single-arm, Multicenter, Open, Phase II Study

Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR);

Complete response rate in subjects at 3 month

Time from first response(PR or CR) to disease progression or death from any cause.

Time from complete response (CR) to disease progression or death from any cause.

Time from partial response (PR) to disease progression or death from any cause.

Time from JWCAR029 infusion to first documentation of CR or PR

Maximum observed concentration of Relmacabtagene Autoleucel in peripheral blood

Time to maximum concentration of Relmacabtagene Autoleucel in peripheral blood

Area under the concentration vs time curve of Relmacabtagene Autoleucel

The concentration of Car-T cell in peripheral blood

Hematologic Neoplasms

Hematologic Diseases

Yuqing Song, PhD

Medical JWCAR029

Xinjian Liu

To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world

The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Relmacabtagene Autoleucel in Patients With LBCL	NCT06142175	Large B-cell Ly...	Relmacabtagene ...	18 Years -	Shanghai Ming Ju Biotechnology Co., Ltd.
Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL	NCT06093841	Lymphoma, Large... Follicular Lymp... High-grade B-ce... Mediastinal B-C...	Relmacabtagene ... Fludarabine Cyclophosphamid...	18 Years -	Shanghai Ming Ju Biotechnology Co., Ltd.
Relmacabtagene Autoleucel in Hematologic Malignancies	NCT06142188	Lymphoma, B-Cel... Large B-cell Ly... Follicular Lymp...	Relmacabtagene ...	18 Years -	Shanghai Ming Ju Biotechnology Co., Ltd.

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