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

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ClinicalTrials.gov Identifier: NCT04696432
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
This is a single-center, relapsed/refractory B-cell Non-Hodgkin's Lymphoma study to evaluate the safety and efficacy of EXP039 in relapsed and/refractory B-cell Non-Hodgkin's Lymphoma.

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, 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 : September 21, 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: 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. Incidence and severity of Treatment emergent adverse events [ Time Frame: Up to 12 months ]
    Occurrence of study related adverse events ,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. The last of EXP039 in the peripheral blood after infusion [ Time Frame: Up to 12 Months ]
    Detect CAR-T copies number by qPCR

  3. AUC0h-inf of EXP039 in the peripheral blood [ Time Frame: up to 12 months ]
    Detect CAR-T copies number by qPCR

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

  5. 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

  6. Progression-free survival (PFS) [ Time Frame: 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

  7. Overall survival rate (OSR) [ Time Frame: 12 weeks, 6 months, 12 months ]
    The time from EXP039 infusion to the date of death

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



Information from the National Library of Medicine

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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. Age 18-70 years old, male or female
  2. Expected survival ≥ 12 weeks
  3. ECOG score 0-2
  4. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria;
  5. Patients with a clear diagnosis of relapsed and/or refractory B-NHL, including DLBCL, FL and MCL
  6. 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
  7. No contraindications of apheresis
  8. At least one measurable lesion according to Lugano 2014 criteria
  9. Adequate organ function
  10. The patient volunteered to participate in the study and signed the informed consent.

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 other uncontrolled, active disease that interferes with trial participation
  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 performed within 2 weeks before enrollment
  11. Previous use of any CAR T cell product or other genetically modified T cell therapy
  12. The investigators considered other conditions unsuitable for inclusion.

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): NCT04696432


Contacts
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Contact: Lanfang Li, PhD&MD 022-23340123-3210 lilanfangmeng@163.com
Contact: Jing Zhao 022-23340123-3210 sharry4601@126.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute & Hosipital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Lanfang Li, PhD&MD    022-23340123-3210    lilanfangmeng@163.com   
Contact: Jing Zhao    022-23340123-3210    sharry4601@126.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT04696432    
Other Study ID Numbers: 0702-021
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: September 2020

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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 Tianjin Medical University Cancer Institute and 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