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

Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04089215
Collaborator
(none)
82
Enrollment
10
Locations
1
Arm
63.7
Anticipated Duration (Months)
8.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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. 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 108 CAR+ T cells and 1.5 x 108 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 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) Non-Hodgkins Lymphoma
Actual Study Start Date :
Jun 11, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) in LBCL subjects in cohort A; [3 months]

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

  2. Complete response rate (CRR) in FL subjects in cohort B [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 LBCL subjects [3 months]

  2. Objective response rate (ORR) in cohort B of FL subjects [3 months]

  3. Adverse events (AEs) [up to 24 months after JWCAR029 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) [up to 24 months after JWCAR029 infusion]

    Time from first response(PR or CR) to disease progression or death from any cause.

  5. Duration of complete remission (DoCR) [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) [up to 24 months after JWCAR029 infusion]

    Time from partial response (PR) to disease progression or death from any cause.

  7. Time to response (TTR) [up to 24 months after JWCAR029 infusion]

    Time from JWCAR029 infusion to first documentation of CR or PR

  8. Time to complete response (TTCR) [up to 24 months after JWCAR029 infusion]

    Time from JWCAR029 infusion to first documentation of CR

  9. Pharmacokinetic (PK)- Cmax of JWCAR029 [up to 1 year after JWCAR029 infusion]

    Maximum observed concentration of JWCAR029 in peripheral blood

  10. Pharmacokinetic (PK)- Tmax of JWCAR029 [up to 1 year after JWCAR029 infusion]

    Time to maximum concentration of JWCAR029 in the peripheral blood

  11. Pharmacokinetic (PK)- AUC of JWCAR029 [up to 1 year after JWCAR029 infusion]

    Area under the concentration vs time curve of JWCAR029

  12. Progression-free survival (PFS) [up to 2 year after JWCAR029 infusion]

  13. Overall survival [up to 2 year after JWCAR029 infusion]

  14. Quality of Life C30 questionnaire (EORTC-QLQ-C30) [up to 2 year after JWCAR029 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) [up to 2 year after JWCAR029 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 [up to 2 year after JWCAR029 infusion]

  17. ICU and non-ICU hospitalization reasons [up to 2 year after JWCAR029 infusion]

  18. Anti-therapeutic JWCAR029 antibody [up to 2 year after JWCAR029 infusion]

  19. Changes of T cell counts, subgroups and serum cytokines [up to 2 year after JWCAR029 infusion]

  20. CD19 expression in tumor biopsy samples [up to 2 year after JWCAR029 infusion]

  21. Changes of inflammation biomarkers-CRP [up to 1 year after JWCAR029 infusion]

  22. Changes of inflammation biomarkers-serum ferritin [up to 1 year after JWCAR029 infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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:

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China
2 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China
3 Beijing Hospital Beijing Beijing China
4 Peking Union Medical College Hospital Beijing Beijing China
5 Guangdong General Hospital Guangzhou Guangdong China
6 The First Affiliated Hospital of Zhenzhou Universtity Zhenzhou Henan China
7 Jiangsu Cancer Hospital Nanjing Jiangsu China
8 Shanghai East Hospital Shanghai Shanghai China
9 Institute of Hematology&Hospital of Blood Disease CAMS Tianjin Tianjin China
10 Zhejiang Cancer Hospital Hangzhou Zhejiang China

Sponsors and Collaborators

  • Shanghai Ming Ju Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Yuqin Song, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Ming Ju Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04089215
Other Study ID Numbers:
  • JWCAR029-002
First Posted:
Sep 13, 2019
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Jan 22, 2021