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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

Tracking Information
First Submitted Date  ICMJE March 20, 2020
First Posted Date  ICMJE March 23, 2020
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE October 14, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
Occurrence of study related adverse events [ Time Frame: 12 weeks ]
Incidence and severity of Treatment emergent adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
  • Overall response rate (ORR) [ Time Frame: 12 months ]
    Lugano criteria(NHL,2014).
  • Duration of remission (DOR) [ Time Frame: 12 months ]
  • Progression free survival (PFS) [ Time Frame: 12 months ]
  • Overall survival (OS) [ Time Frame: 12 weeks, 6 months, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Safety and Efficacy of EXP039 Treatment in NHL Subjects
Official Title  ICMJE A Study Evaluating Safety and Efficacy of EXP039 Treatment in Relapsed or Refractory NHL Subjects
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin's B-cell Lymphoma
Intervention  ICMJE Biological: CD19/CD20-directed CAR-T cells
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Other Name: EXP039
Study Arms  ICMJE Experimental: EXP039
Autologous EXP039 administered by intravenous (IV) infusion
Intervention: Biological: CD19/CD20-directed CAR-T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2020)
10
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04317885
Other Study ID Numbers  ICMJE 0702-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aibin Liang,MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
Study Sponsor  ICMJE Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aibin Liang, MD, Ph.D Shanghai Tongji Hospital, Tongji University School of Medicine
PRS Account Shanghai Tongji Hospital, Tongji University School of Medicine
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP