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Chimeric Switch Receptor Modified T Cells for Patients With PD-L1+ Recurrent or Metastatic Malignant Tumors

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ClinicalTrials.gov Identifier: NCT02930967
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
Marino Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Jinwen Sun, China Meitan General Hospital

Tracking Information
First Submitted Date  ICMJE October 10, 2016
First Posted Date  ICMJE October 12, 2016
Last Update Posted Date October 12, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0. [ Time Frame: 2 years ]
safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
  • treatment response rate of CSR T cell infusion [ Time Frame: 4 weeks ]
    defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD).
  • overall survival rate [ Time Frame: 2 years ]
  • progression-free survival [ Time Frame: 6 months ]
  • proliferation of CSR T cells in patients [ Time Frame: 2 years ]
  • Persistence of CSR T cells in patients [ Time Frame: 2 years ]
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 Chimeric Switch Receptor Modified T Cells for Patients With PD-L1+ Recurrent or Metastatic Malignant Tumors
Official Title  ICMJE A Safety and Efficacy Study of Chimeric Switch Receptor Modified T Cells in Patients With Recurrent or Metastatic Malignant Tumors
Brief Summary A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or metastatic malignant tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent PD-L1+ Malignant Tumors
  • Metastatic PD-L1+ Malignant Tumors
Intervention  ICMJE Biological: autologous CSR T
Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, a prescribed dose of CSR T cells will be intravenously infused to patient in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).
Study Arms  ICMJE Experimental: CSR T cells

A dose escalation clinical study aimed to assess the safety and efficacy of CSR T cells in patients with PD-L1 positive tumors.

CSR T dosage ranging from: 5×10^4 /kg to 1×10^7 /kg will be tested.

Intervention: Biological: autologous CSR T
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: October 11, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with PD-L1 positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic cancer, renal cancer, colorectal cancer, lymphoma, breast cancer and lung cancer;
  2. measurable tumors by RECIST1.1 standard;
  3. patients are 18 to 70 years old;
  4. life expectancy > 3months;
  5. KPS ≥70;
  6. satisfactory major organ functions: adequate heart function with LVEF≥50%; no obvious abnormities in ECG; pulse oximetry ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl ;
  7. Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L;
  8. women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.

Exclusion Criteria:

  1. patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy
  2. active infection.
  3. HIV positive.
  4. active hepatitis B virus infection or hepatitis C virus infection.
  5. currently enrolled in other study.
  6. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
  7. patients with allergic disease, or are allergic to T cell products or other biological agents used in the study.
  8. patients whose tumors have metastasized to bone, or have clinical signs of bone metastasis, such as bone and joint pain.
  9. patients with brain metastasis, or have clinical signs of brain metastasis, such as loss of self-consciousness.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shidong Wei, MD +86-13146634751 liqinghe9644679@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02930967
Other Study ID Numbers  ICMJE K16-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jinwen Sun, China Meitan General Hospital
Study Sponsor  ICMJE China Meitan General Hospital
Collaborators  ICMJE Marino Biotechnology Co., Ltd.
Investigators  ICMJE
Principal Investigator: Jinwen Sun, MD China Meitan General Hospital
PRS Account China Meitan General Hospital
Verification Date October 2016

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