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A Study Evaluating Safety and Efficacy of EXP039 Treatment in NHL Subjects

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ClinicalTrials.gov Identifier: NCT04317885
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine

Study Description
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Brief Summary:
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of EXP039 in treatment of relapsed 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:

This study plans to enroll 25 patients to assess the safety and efficacy of EXP039. Subjects who meet the eligibility criteria will receive a single dose of EXP039 injection.

The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Evaluating Safety and Efficacy of EXP039 Treatment in Relapsed or Refractory NHL Subjects
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: 12 weeks ]
    Incidence and severity of Treatment emergent adverse events


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 12 months ]
    Lugano criteria(NHL,2014).

  2. Duration of remission (DOR) [ Time Frame: 12 months ]
  3. Progression free survival (PFS) [ Time Frame: 12 months ]
  4. Overall survival (OS) [ Time Frame: 12 weeks, 6 months, 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Volunteered to participate in this study and signed informed consent
  • 2. Age 18-75 years old, male or female
  • 3. Patients with relapsed or refractory B-NHL;
  • 4. At least one measurable lesion (LDi ≥ 1.5 cm);
  • 5. At least two weeks from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis;
  • 6. LVEF≥ 50% (UCG)
  • 7. No active pulmonary infections, normal pulmonary function and SpO2≥92%
  • 8. Laboratory criteria: ANC≥1.0×109/L; Platelets≥50×109/L; Serum total bilirubin ≤1.5x ULN; Creatinine≤ ULN; AST and ALT≤3x ULN
  • 9. No contraindications of apheresis;
  • 10. Expected survival ≥ 3months
  • 11. ECOG score 0 or 1
  • 12.The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell.

Exclusion Criteria:

  • 1. Have a history of allergy to cellular products;
  • 2. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
  • 3. A history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
  • 4. Patients with central nervous system involvement;
  • 5. Patients with autoimmune diseases, immunodeficiency or other conditions requiring immunosuppressive therapy;
  • 6. Received allogeneic hematopoietic stem cell transplantation before;
  • 7. Previous use of any CAR T cell product or other genetically modified T cell therapy;
  • 8. Autologous stem cell transplantation within 6 weeks before infusion;
  • 9. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics, or intravenous infusion of antibiotics within 1 week prior to cell infusion. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;
  • 10. Live vaccination within 4 weeks prior to apheresis;
  • 11. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
  • 12. A history of alcohol abuse, drug use or mental illness;

  • 13. Subjects who are not sterilized have any of the following conditions:

    1. are pregnant/lactating; or
    2. planned pregnancy during the trial; or
    3. being fertile and unable to use effective contraception;
  • 14. Severe hypersensitivity to fludarabine or cyclophosphamide;

  • 15. A history of other primary cancers other than the following:

    1. Non-melanoma tumors such as basal cell carcinoma of the skin that are cured by excision
    2. Cured in situ cancers such as cervical, bladder, or breast cancer
  • 16. The investigators consider that the subject has other conditions that are not suitable for this trial.
Contacts and Locations
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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): NCT04317885


Contacts
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Contact: Aibin Liang, MD, Ph.D 0086-021-66111019 lab7182@tongji.edu.cn
Contact: Ping Li, MD,Ph.D. 0086-021-66111015 lilyforever76@126.com

Locations
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China, Shanghai
Shanghai Tongji Hospital, Tongji University School of Medicine Recruiting
Shanghai, Shanghai, China, 200065
Contact: Aibin Liang, MD, Ph.D    0086-021-66111019    lab7182@tongji.edu.cn   
Sponsors and Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Investigators
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Principal Investigator: Aibin Liang, MD, Ph.D Shanghai Tongji Hospital, Tongji University School of Medicine
More Information
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Responsible Party: Aibin Liang，MD，Ph.D., Director, Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine
ClinicalTrials.gov Identifier: NCT04317885    
Other Study ID Numbers: 0702-015
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: September 25, 2020
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
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