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

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ClinicalTrials.gov Identifier: NCT04089215
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Ming Ju Biotechnology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Diffuse Large B Cell Lymphoma Follicular 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 R/R Non-Hodgkins Lymphoma in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect the patient reported quality of life changes and immune response after JWCAR029 treatment.

There will be two cohorts of cohort A and cohort B. Diffuse large B cell lymphoma (DLBCL) 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 JCAR017 infusion.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
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) Non-Hodgkins Lymphoma
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : January 31, 2022


Arm Intervention/treatment
Experimental: JWCAR029 treatment
JWCAR029 be administrated in two dose level
Biological: 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




Primary Outcome Measures :
  1. Objective response rate (ORR) in DLBCL subjects in cohort A; [ Time Frame: 3 months ]
    Objective response rate (ORR) in 3 month in cohort A of diffuse large B cell lymphoma (DLBCL) subjects;

  2. Complete response rate (CRR) in FL subjects in cohort B [ Time Frame: 3 months ]
    Complete response rate (CRR) in 3 month in cohort B of follicular lymphoma (FL) subjects


Secondary Outcome Measures :
  1. Complete response rate (CRR) in cohort A of DLBCL subjects [ Time Frame: 3 months ]
  2. Objective response rate (ORR) in cohort B of FL subjects [ Time Frame: 3 months ]
  3. Adverse events (AEs) [ Time Frame: up to 24 months after JWCAR infusion ]
    Number of participants with adverse events, type of adverse events, severity of adverse events, and number of participants with laboratory abnormalities, type of laboratory abnormalities and severity of laboratory abnormalities.

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

  5. 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.

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

  7. Time to response (TTR) [ Time Frame: up to 24 months after JWCAR infusion ]
    Time from JWCAR029 infusion to first documentation of CR or PR

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

  9. Pharmacokinetic (PK)- Cmax of JWCAR029 [ Time Frame: up to 1 year after JWCAR infusion ]
    Maximum observed concentration of JWCAR029 in peripheral blood

  10. Pharmacokinetic (PK)- Tmax of JWCAR029 [ Time Frame: up to 1 year after JWCAR infusion ]
    Time to maximum concentration of JWCAR029 in the peripheral blood

  11. Pharmacokinetic (PK)- AUC of JWCAR029 [ Time Frame: up to 1 year after JWCAR infusion ]
    Area under the concentration vs time curve of JWCAR029

  12. Progression-free survival (PFS) [ Time Frame: up to 2 year after JWCAR infusion ]
  13. Overall survival [ Time Frame: up to 2 year after JWCAR infusion ]
  14. Quality of Life C30 questionnaire (EORTC-QLQ-C30) [ Time Frame: up to 2 year after JWCAR infusion ]
    EORTC-QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale

  15. European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L) [ Time Frame: up to 2 year after JWCAR infusion ]
    The EQ-5D-5L consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems)

  16. ICU and non-ICU hospitalization days [ Time Frame: up to 2 year after JWCAR infusion ]
  17. ICU and non-ICU hospitalization reasons [ Time Frame: up to 2 year after JWCAR infusion ]
  18. Anti-therapeutic JWCAR029 antibody [ Time Frame: up to 2 year after JWCAR infusion ]
  19. Changes of T cell counts, subgroups and serum cytokines [ Time Frame: up to 2 year after JWCAR infusion ]
  20. CD19 expression in tumor biopsy samples [ Time Frame: up to 2 year after JWCAR infusion ]
  21. Changes of inflammation biomarkers-CRP [ Time Frame: up to 1 year after JWCAR infusion ]
  22. Changes of inflammation biomarkers-serum ferritin [ Time Frame: up to 1 year after JWCAR infusion ]


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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:

  • Subjects must meet all of the following criteria to participate in the study:

    1. ≥ 18 years old;
    2. Sign on the informed consent;
    3. Subject must have histologically confirmed non-specific diffuse large B lymphoma and 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:

  1. Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
  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.

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): NCT04089215


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

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
Beijing Hospital Recruiting
Beijing, Beijing, China
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
China, Henan
The First Affiliated Hospital of Zhenzhou Universtity Recruiting
Zhenzhou, Henan, China
China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China
China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China
China, Tianjin
Institute of Hematology&Hospital of Blood Disease CAMS Recruiting
Tianjin, Tianjin, China
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, China
Contact: Rong Tao         
Sponsors and Collaborators
Shanghai Ming Ju Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Yuqin Song Beijing Cancer Hospital

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Responsible Party: Shanghai Ming Ju Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04089215     History of Changes
Other Study ID Numbers: JWCAR029-002
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell