CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
NCT ID: NCT04718883
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
59 participants
INTERVENTIONAL
2021-01-13
2028-08-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
R/R MCL patients will be enrolled in dose level of 1.0 x 10\^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
JWCAR029 treatment
JWCAR029 be administrated at dose level: 1 x 10\^8 CAR+T cells
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
JWCAR029 will be administered at dose level: 1 x 10\^8 CAR+T cells
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
JWCAR029 will be administered at dose level: 1 x 10\^8 CAR+T cells
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sign on the informed consent;
* Subject must have histologically confirmed mantle cell lymphoma;
* Relapsed/refractory patients;
* Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Expected survival is greater than 12 weeks;
* Adequate organ function;
* Adequate vascular access for leukapheresis procedure;
* Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
* Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
* Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.
Exclusion Criteria
* History of another primary malignancy that has not been in remission for at least 2 years;
* Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
* Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
* Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
* Presence of acute or chronic graft-versus-host disease (GVHD);
* History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
* Pregnant or nursing women;
* Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
* Received allo-hematopoietic stem cell transplantation therapy previously.
* Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
* Received CAR T-cell or other genetically-modified T-cell therapy previously.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Ming Ju Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Consonancy Hospital
Fuzhou, Fujiang, China
Guangdong Province people hospital
Guanzhou, Guangdong, China
Henan Province Cancer Hospital
Zhengzhou, Henan, China
Jiangsu Province People Hospital
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang province Cancer Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Xie Y, Zhou K, Li L, Liang A, Mei H, Zou D, Li W, Jin J, Jin Z, Jing HM, Yang H, Chen T, Huang H, He P, Cao J, Zhu J, Song Y, Xia Z, Gu YE, Zang Y, Zhou Z, Tian ZZ. Phase 2 Study of Relmacabtagene Autoleucel (CD19 CAR-T) for Relapsed/Refractory Mantle Cell Lymphoma in Chinese Adults. Blood Adv. 2025 Aug 14:bloodadvances.2024015763. doi: 10.1182/bloodadvances.2024015763. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JWCAR029-005
Identifier Type: -
Identifier Source: org_study_id