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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02930967
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Marino Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Jinwen Sun, China Meitan General Hospital

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.

Condition or disease Intervention/treatment Phase
Recurrent PD-L1+ Malignant Tumors Metastatic PD-L1+ Malignant Tumors Biological: autologous CSR T Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Chimeric Switch Receptor Modified T Cells in Patients With Recurrent or Metastatic Malignant Tumors
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
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.

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%).

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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).

  2. overall survival rate [ Time Frame: 2 years ]
  3. progression-free survival [ Time Frame: 6 months ]
  4. proliferation of CSR T cells in patients [ Time Frame: 2 years ]
  5. Persistence of CSR T cells in patients [ Time Frame: 2 years ]

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

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.

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 identifier (NCT number): NCT02930967

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Contact: Shidong Wei, MD +86-13146634751

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China Meitan General Hospital Recruiting
Beijing, China, 100028
Contact: Shidong Wei, MD    +86-13146634751   
Sponsors and Collaborators
China Meitan General Hospital
Marino Biotechnology Co., Ltd.
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Principal Investigator: Jinwen Sun, MD China Meitan General Hospital

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Responsible Party: Jinwen Sun, Director of Department of General Surgery and Surgical Oncology, China Meitan General Hospital Identifier: NCT02930967     History of Changes
Other Study ID Numbers: K16-3
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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