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

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ClinicalTrials.gov Identifier: NCT04655677
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
This is a single-center, non-randomized study to evaluate the safety and efficacy of EXP039 in relapsed and/or refractory NHL patients.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's B-cell Lymphoma Biological: CD19/CD20-directed CAR-T cells Phase 1

Detailed Description:
The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), EXP039 infusion and Follow-up Visit.

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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 : August 25, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous EXP039 administered by intravenous (IV) infusion
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. Occurrence of study related adverse events [ Time Frame: 12 Months ]
    Incidence and severity of Treatment emergent adverse events


Secondary Outcome Measures :
  1. Maximum concentration (Cmax) of EXP039 in the peripheral blood [ Time Frame: up to 12 months ]
    Detect CAR-T copies number by qPCR

  2. Time to maximum concentration (Tmax) of EXP039 in the peripheral blood [ Time Frame: up to 12 months ]
    Detect CAR-T copies number by qPCR

  3. Tlast of EXP039 in the peripheral blood after infusion [ Time Frame: up to 12 months ]
    Detect CAR-T copies number by qPCR

  4. AUC0h-28d of EXP039 in the peripheral blood [ Time Frame: 4 weeks ]
    Detect CAR-T copies number by qPCR

  5. Objective response rate (ORR) [ Time Frame: 4 weeks, 12 weeks, 6 months, 9 months, 12 months ]
    Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria

  6. 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

  7. Progression-free survival (PFS) [ Time Frame: 4 weeks, 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

  8. Overall survival rate (OSR) [ 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 ≥18 years old ≤70 Years old, 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 and adequate bone marrow reserve

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. 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
  5. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
  6. Patients who have been previously infected with tuberculosis
  7. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of EXP039
  8. Patients with central nervous system involvement
  9. Any systemic antitumor therapy performed within 2 weeks before enrollment
  10. Previous 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): NCT04655677


Contacts
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Contact: Daobin Zhou, PhD&MD 010-69155020 zhoudb@pumch.cn
Contact: Yan Zhang 010-69155660 zhangyan10659@pumch.cn

Locations
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China, Beijing/China
Peking Union Medical College Hospital Recruiting
Beijing, Beijing/China, China, 100000
Contact: Daobin Zhou, PhD&MD    010-69155020    zhoudb@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Daobin Zhou, PhD&MD Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04655677    
Other Study ID Numbers: 0702-023
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: July 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
Keywords provided by Peking Union Medical College Hospital:
CD19/CD20-directed CAR-T cells
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