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CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT04718883
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Ming Ju Biotechnology Co., Ltd.

Study Description
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Brief Summary:
This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Phase 2

Detailed Description:

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment.

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 2 years following JWCAR029 infusion.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: JWCAR029 treatment
JWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells
 Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
JWCAR029 will be administered at dose level: 1 x 10^8 CAR+T cells


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 3 months ]
    Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects


Secondary Outcome Measures :
  1. Complete response rate (CRR) [ Time Frame: 3 months ]
    Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

  2. The best objective response rate [ Time Frame: 3 months ]
    The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

  3. The best complete response rate [ Time Frame: 3 months ]
    The best complete response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

  4. Number of participants with adverse events (AEs) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Number of participants with adverse events

  5. Type of adverse events (AEs) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Type of adverse events

  6. Severity of adverse events(AEs) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Severity of adverse events

  7. Number of participants with laboratory abnormalities [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Number of participants with laboratory abnormalities

  8. Type of laboratory abnormalities [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Type of laboratory abnormalities

  9. Severity of laboratory abnormalities [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Severity of laboratory abnormalities

  10. Duration of response (DOR) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Time from first response(PR or CR) to disease progression or death from any cause

  11. Duration of complete remission (DoCR) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Time from complete response (CR) to disease progression or death from any cause

  12. Duration of partial remission (DoPR) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Time from partial response (PR) to disease progression or death from any cause.

  13. Time to response (TTR) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Time from JWCAR029 infusion to first documentation of complete response (CR) or partial response (PR)

  14. Time to complete response (TTCR) [ Time Frame: Up to 24 months after JWCAR029 infusion ]
    Time from JWCAR029 infusion to first documentation of complete response (CR)

  15. Cmax of JWCAR029 [ Time Frame: Up to 1 year after JWCAR029 infusion ]
    Maximum observed concentration of JWCAR029 in peripheral blood

  16. Tmax of JWCAR029: [ Time Frame: Up to 1 year after JWCAR029 infusion ]
    Time to maximum concentration of JWCAR029 in the peripheral blood

  17. AUC of JWCAR029: [ Time Frame: Up to 1 year after JWCAR029 infusion ]
    Area under the concentration vs time curve of JWCAR029 in the peripheral blood

  18. Progression-free survival (PFS) [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Progression-free survival

  19. Overall survival (OS) [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Overall survival

  20. Anti-therapeutic JWCAR029 antibody [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Anti-therapeutic JWCAR029 antibody

  21. Changes of T cell counts [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Changes of T cell counts

  22. Changes of Subgroups of T cell [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Changes of Subgroups of T cell

  23. Changes of serum cytokines [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Changes of serum cytokines

  24. CD19 expression in tumor biopsy samples [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    CD19 expression in tumor biopsy samples

  25. Changes in inflammatory biomarkers such as CRP [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Changes in inflammatory biomarkers such as CRP

  26. Changes in inflammatory biomarkers such as ferritin [ Time Frame: Up to 2 year after JWCAR029 infusion ]
    Changes in inflammatory biomarkers such as CRP


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old;
  • 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:

  • 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, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718883


Contacts
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Contact: JWCAR029 Medical +86 21 50464201 JWCAR029Medical@jwtherapeutics.com

Locations
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China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Jun Zhu         
Peking University Third Hospital Recruiting
Beijing, Beijing, China
Contact: Hongmei Jing         
China, Fujiang
Fujian Medical University Consonancy Hospital Recruiting
Fuzhou, Fujiang, China
Contact: Jianda Hu         
China, Guangdong
Guangdong Province people hospital Recruiting
Guanzhou, Guangdong, China
Contact: WenYu Li         
China, Henan
Henan Province Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Keshu Zhou         
China, Jiangsu
Jiangsu Province People Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Jianyong Li         
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Junning Cao         
Zhongshan Hospital affiliated to Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Peng Liu         
China, Tianjin
Institute of Hematology, Chinese Academy of Medical Sciences Recruiting
Tianjin, Tianjin, China
Contact: Dehui Zou         
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China
Contact: Lanfang Li         
China, Zhejiang
The First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Jie Jin         
Zhejiang province Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Haiyan Yang         
Sponsors and Collaborators
Shanghai Ming Ju Biotechnology Co., Ltd.
More Information
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Responsible Party: Shanghai Ming Ju Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04718883    
Other Study ID Numbers: JWCAR029-005
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Ming Ju Biotechnology Co., Ltd.:
JWCAR029
B-Cell Malignancies
Non-Hodgkin lymphoma
CAR T cells
 Chimeric antigen receptor
Relapsed/Refractory
Mantle Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin