CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma
NCT ID: NCT04089215
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
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ACTIVE_NOT_RECRUITING
PHASE2
82 participants
INTERVENTIONAL
2019-06-11
2024-09-30
Brief Summary
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Detailed Description
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There will be two cohorts of cohort A and cohort B. Large B cell lymphoma (LBCL) patients will be enrolled in cohort A and follicular lymphoma patients will be enrolled in cohort B. Two dose levels of 1.0 x 10\^8 CAR+ T cells and 1.5 x 10\^8 CAR+ T cells are adopted in this study in both cohorts, subjects will be randomly assigned into the two dose levels with a 1:1 ratio. All sujects will be followed for 2 years following JWCAR029 infusion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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JWCAR029 treatment
JWCAR029 be administrated in two dose level
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
JWCAR029 be administered at dose level: 1 x 10\^8 CAR+T cells and 1.5 x 10\^8 CAR+T cells
Interventions
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CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
JWCAR029 be administered at dose level: 1 x 10\^8 CAR+T cells and 1.5 x 10\^8 CAR+T cells
Eligibility Criteria
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Inclusion Criteria
1. ≥ 18 years old;
2. Sign on the informed consent;
3. Subject must have histologically confirmed large B lymphoma or follicular lymphoma;
4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
6. Adequate organ function;
7. Adequate vascular access for leukapheresis procedure;
8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
10. 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
2. History of another primary malignancy that has not been in remission for at least 2 years;
3. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
4. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
6. Presence of acute or chronic graft-versus-host disease (GVHD);
7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
8. Pregnant or nursing women;
9. Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
11. Received CAR T-cell or other genetically-modified T-cell therapy previously.
18 Years
ALL
No
Sponsors
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Shanghai Ming Ju Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yuqin Song
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhenzhou Universtity
Zhenzhou, Henan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Institute of Hematology&Hospital of Blood Disease CAMS
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Ying Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Zhang P, Yang S, Zhou Z, Zheng H, Song Y, Zhu J. Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China. Cancer Med. 2021 Feb;10(3):999-1011. doi: 10.1002/cam4.3686. Epub 2020 Dec 31.
Song Y, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Xia Z, Zhang Y, Zhou Z, Zhu J. Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study. Br J Haematol. 2025 Sep 1. doi: 10.1111/bjh.20122. Online ahead of print.
Ying Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study. Cytotherapy. 2023 May;25(5):521-529. doi: 10.1016/j.jcyt.2022.10.011. Epub 2023 Feb 24.
Ying Z, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Preliminary efficacy and safety of Relmacabtagene autoleucel (Carteyva) in adults with relapsed/refractory follicular lymphoma in China: A phase I/II clinical trial. Am J Hematol. 2022 Dec;97(12):E436-E438. doi: 10.1002/ajh.26711. Epub 2022 Sep 14. No abstract available.
Other Identifiers
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JWCAR029-002
Identifier Type: -
Identifier Source: org_study_id