CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma

NCT04089215 | Unknown Phase 2

• 1 other identifier: JWCAR029-002
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 10

Brief Summary

This is a phase II, open-label, single-arm, multicenter study to asess the efficacy and safety of JWCAR029 in adult R/R Non-Hodgkins Lymphoma subjects in China.

Conditions

Lymphoma, Non-Hodgkin; Diffuse Large B Cell Lymphoma; Follicular Lymphoma

Keywords

JWCAR029; B-Cell Malignancies; non-Hodgkin lymphoma; CAR T cells; Chimeric antigen receptor; Relapsed/Refractory

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) in LBCL subjects in cohort A;

  Objective response rate (ORR) in 3 month in cohort A of large B cell lymphoma (LBCL) subjects；

  3 months

• Complete response rate (CRR) in FL subjects in cohort B

  Complete response rate (CRR) in 3 month in cohort B of follicular lymphoma (FL) subjects

  3 months

Secondary Outcomes (22)

• Complete response rate (CRR) in cohort A of LBCL subjects

  3 months

• Objective response rate (ORR) in cohort B of FL subjects

  3 months

• Adverse events (AEs)

  up to 24 months after JWCAR029 infusion

• Duration of response (DOR)

  up to 24 months after JWCAR029 infusion

• Duration of complete remission (DoCR)

  up to 24 months after JWCAR029 infusion

Study Arms (1)

JWCAR029 treatment

EXPERIMENTAL

JWCAR029 be administrated in two dose level

Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

Interventions

CD19-targeted Chimeric Antigen Receptor (CAR) T Cells BIOLOGICAL

JWCAR029 be administered at dose level: 1 x 10\^8 CAR+T cells and 1.5 x 10\^8 CAR+T cells

JWCAR029 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to participate in the study:
• ≥ 18 years old;
• Sign on the informed consent;
• Subject must have histologically confirmed large B lymphoma or follicular lymphoma;
• 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;
• 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.

You may not qualify if:

• Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
• 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, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
• 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.

Sponsors & Collaborators

• Shanghai Ming Ju Biotechnology Co., Ltd.: lead

Study Sites (10)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Zhenzhou Universtity

Zhenzhou, Henan, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

Institute of Hematology&Hospital of Blood Disease CAMS

Tianjin, Tianjin Municipality, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (4)

• 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.

  PMID: 33382529 RESULT

• 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 Oct;207(4):1476-1483. doi: 10.1111/bjh.20122. Epub 2025 Sep 1.

  PMID: 40888120 DERIVED

• 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.

  PMID: 36842849 DERIVED

• 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.

  PMID: 36053875 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Recurrence

Interventions

Automobiles

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Vehicles; Transportation; Technology, Industry, and Agriculture

Study Officials

• Yuqin Song

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 13, 2019
• Study Start: June 11, 2019
• Primary Completion: September 10, 2021
• Study Completion: September 30, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)