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

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ClinicalTrials.gov Identifier: NCT04693676
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

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
Non-Hodgkin's B-cell Lymphoma 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 10, 2020
Estimated Primary Completion Date : July 10, 2022
Estimated Study Completion Date : October 10, 2022

Resource links provided by the National Library of Medicine


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 Name: EXP039




Primary Outcome Measures :
  1. MTD [ Time Frame: up to12 Months ]
    maximum tolerated dose or clinical recommended dose

  2. DLT [ Time Frame: up to 28 days after EXP039 infusion ]
    Dose limiting toxicity

  3. AE/SAE/AESI [ Time Frame: 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 [ Time Frame: up to12 Months ]
    After EXP039 infusion, peripheral blood EXP039 CAR expansion and persistence in vivo.

  2. Objective response rate (ORR) [ Time Frame: 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: 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: 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: Time Frame: 12 weeks, 6 months, 12 months ]
    The time from EXP039 infusion to the date of death



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

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): NCT04693676


Contacts
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Contact: Jie Jin, PhD&MD +86-0571-87236702 jiej0503@163.com

Locations
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China, Zhejiang
First Affiliated Hospital of Zhejiang University College of Medicine Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Jie Jin, PhD&MD    +86-0571-87236702    jiej0503@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
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Principal Investigator: Jie Jin, PhD&MD First Affiliated Hospital of Zhejiang University College of Medicine
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Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT04693676    
Other Study ID Numbers: 0702-025
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: November 2020
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
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases