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A Study of EXP039 Treatment in Subjects With r/r NHL Subjects

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04693676
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
27
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-arm, open label, dose escalation, phase I study of EXP039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.

Condition of disease:B cell Non-Hodgkin's Lymphoma Intervention/treatment:

Biological/Vaccine: CD19/CD20-direct CAR-T cells. phase: phase 1

Condition or Disease Intervention/Treatment Phase
  • Biological: CD19/CD20-directed CAR-T cells
 Phase 1

Detailed Description

This is a single-arm, open label, "3+3" dose escalation, phase I study to evaluate the safety and preliminary efficacy of EXP039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled.

Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of EXP039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to EXP039 infusion. All subjects who have received EXP039 infusion will be followed for up to 12 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study Evaluating Safety and Efficacy of EXP039 Treatment in Subjects With Relapsed and/or Refractory NHL
Actual Study Start Date :
Jul 10, 2020
Anticipated Primary Completion Date :
Jul 10, 2022
Anticipated Study Completion Date :
Oct 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: EXP039

Autologous EXP039 administered by intravenous (IV) infusion

Biological: CD19/CD20-directed CAR-T cells
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Other Names:
  • EXP039

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MTD [up to12 Months]

      maximum tolerated dose or clinical recommended dose

    2. DLT [up to 28 days after EXP039 infusion]

      Dose limiting toxicity

    3. AE/SAE/AESI [up to12 Months]

      adverse events (AE), serious adverse event (SAE), pay particular attention to adverse events (AESI) (including cytokine release syndrome (CRS), and nerve toxicity), laboratory tests (type, frequency and severity), vital signs and ECG abnormality rate.

    Secondary Outcome Measures

    1. EXP039 CAR expansion and persistence [up to12 Months]

      After EXP039 infusion, peripheral blood EXP039 CAR expansion and persistence in vivo.

    2. Objective response rate (ORR) [Time Frame 4weeks,12 weeks, 6 months, 9 months, 12 months]

      Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria

    3. Duration of response (DOR) [Time Frame: up to 12 months]

      The time from the date of first response (PR or better) until the date of disease progression after EXP039 infusion

    4. Progression-free survival (PFS) [Time Frame: 4weeks, 12 weeks, 6 months, 9 months ,12 months]

      The time from EXP039 infusion to the date of progression as assessed by Lugano 2014 criteria or death

    5. Overall survival rate (OSR) [Time Frame: 12 weeks, 6 months, 12 months]

      The time from EXP039 infusion to the date of death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The patient volunteered to participate in the study and signed the Informed Consent;

    2. Age between 18 and 70 (including 18 and 70), male or female;

    3. Expected survival ≥ 12 weeks;

    4. ECOG score 0-2

    5. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria;

    6. Patients with a clear diagnosis of relapsed and/or refractory B-NHL, including DLBCL, FL and MCL;

    7. For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded;

    8. No contraindications of apheresis;

    9. At least one measurable lesion according to Lugano 2014 criteria;

    10. Adequate organ function.

    Exclusion Criteria:

    1. Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;

    2. Active HIV, HBV, HCV or treponema pallidum infection ;

    3. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy;

    4. Any uncontrolled, active disease that prevents participation in the trial;

    5. Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion;

    6. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;

    7. Patients who have been previously infected with tuberculosis;

    8. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of EXP039;

    9. Patients with central nervous system involvement;

    10. Any systemic antitumor therapy was performed within 2 weeks before conditional treatment chemotherapy pretreatment;

    11. Prior use of any CAR-T cell product or other genetically modified T-cell therapy;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Zhejiang University College of Medicine Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University

    Investigators

    • Principal Investigator: Jie Jin, PhD&MD, First Affiliated Hospital of Zhejiang University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04693676
    Other Study ID Numbers:
    • 0702-025
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Apr 13, 2021
    Last Verified:
    Nov 1, 2020
    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
    Additional relevant MeSH terms:
    Lymphoma, B-Cell

    Study Results

    No Results Posted as of Apr 13, 2021