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Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

This study is currently recruiting participants.
Verified November 2017 by Zhao Weili, Ruijin Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03355859
First Posted: November 28, 2017
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
MingJu Therapeutics (Shanghai) Co., Ltd
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital
  Purpose
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult patients with relapsed and refractory B-cell Non-Hodgkin lymphoma.

Condition Intervention Phase
Non Hodgkin Lymphoma Biological: JWCAR029 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Adult Subjects With Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Zhao Weili, Ruijin Hospital:

Primary Outcome Measures:
  • Treatment-related adverse events (AEs) [ Time Frame: 2 years ]
    Physiological parameter

  • Dose-limiting toxicities of JWCAR029 [ Time Frame: 28 days after JWCAR029 infusion ]
    Physiological parameter

  • Objective response rate (ORR) [ Time Frame: 2 years ]
    Lugano criteria


Secondary Outcome Measures:
  • Maximum concentration (Cmax) of JWCAR029 in the peripheral blood and bone marrow [ Time Frame: 1 year after JWCAR029 infusion ]
    Flow cytometry and qPCR

  • Time to maximum concentration (Tmax) of JWCAR029 in the peripheral blood and bone marrow [ Time Frame: 1 year after JWCAR029 infusion ]
    Flow cytometry and qPCR

  • Area-under the concentration-vs-time-curve (AUC) of JWCAR029 in the peripheral blood and bone marrow [ Time Frame: 1 year after JWCAR029 infusion ]
    Flow cytometry and qPCR

  • Complete response (CR) rate [ Time Frame: 2 years ]
    Lugano criteria

  • Duration of response [ Time Frame: 2 years ]
    Lugano criteria

  • Progression-free survival (PFS) and PFS ratio [ Time Frame: 2 years ]
    Lugano criteria

  • Overall survival [ Time Frame: 2 years ]
    Physiological parameter

  • Health-related quality of life (HRQoL) [ Time Frame: 2 years ]
    Questionnaire


Estimated Enrollment: 10
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JWCAR029
The safety and efficacy of JWCAR029 will be evaluated in a standard 3+3 dose escalation approach. 4 CAR T dosage will be tested in this study: 1×10^7, 2.5×10^7, 5×10^7, 1×10^8 CAR+ T cells.
Biological: JWCAR029
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with JWCAR029 by intravenous (IV) injection.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Subjects must meet all of the following criteria to be enrolled in this study:

    1. Age ≥ 18 years at the time of consent
    2. Signed written informed consent obtained prior to any study procedures
    3. Relapsed or refractory B-cell NHL.
    4. PET-positive disease BY Lugano classification
    5. Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable.
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    7. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
    8. Adequate vascular access for leukapheresis procedure
    9. Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
    10. Subjects must agree to use appropriate contraception.

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from participation in this study:

    1. Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
    2. History of another primary malignancy that has not been in remission for at least 2 years.
    3. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
    4. Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening
    5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration
    6. Presence of acute or chronic graft-versus-host disease (GVHD)
    7. History of cardiovascular disease
    8. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
    9. Pregnant or nursing women.
    10. Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JWCAR029 treatment in this protocol for subjects receiving retreatment
  Contacts and Locations
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): NCT03355859


Locations
China, Shanghai
Ruijin hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Weili ZHAO, MD, PhD    86-21-64370045 ext 610707    zhao.weili@yahoo.com   
Contact: Shu CHENG, MD, PhD    86-21-64370045 ext 665251    orenge@medmail.com.cn   
Principal Investigator: Weili ZHAO, MD, PhD         
Sub-Investigator: Shu CHENG, MD, PhD         
Sponsors and Collaborators
Zhao Weili
MingJu Therapeutics (Shanghai) Co., Ltd
  More Information

Responsible Party: Zhao Weili, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03355859     History of Changes
Other Study ID Numbers: JWCAR029-001
First Submitted: November 22, 2017
First Posted: November 28, 2017
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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 Zhao Weili, Ruijin Hospital:
Non Hodgkin Lymphoma
CD19-targeted chimeric antigen receptor
JWCAR029

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases