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

Primary Purpose

Recurrent PD-L1+ Malignant Tumors, Metastatic PD-L1+ Malignant Tumors

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

autologous CSR T

About this trial

This is an interventional treatment trial for Recurrent PD-L1+ Malignant Tumors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;
measurable tumors by RECIST1.1 standard;
patients are 18 to 70 years old;
life expectancy > 3months;
KPS ≥70;
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 ;
Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L;
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:

patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy
active infection.
HIV positive.
active hepatitis B virus infection or hepatitis C virus infection.
currently enrolled in other study.
patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
patients with allergic disease, or are allergic to T cell products or other biological agents used in the study.
patients whose tumors have metastasized to bone, or have clinical signs of bone metastasis, such as bone and joint pain.
patients with brain metastasis, or have clinical signs of brain metastasis, such as loss of self-consciousness.

Sites / Locations

China Meitan General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CSR T cells

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0.

safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy

Secondary Outcome Measures

treatment response rate of CSR T cell infusion

defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD).

overall survival rate

progression-free survival

proliferation of CSR T cells in patients

Persistence of CSR T cells in patients

Full Information

NCT ID

NCT02930967

First Posted

October 10, 2016

Last Updated

October 11, 2016

Sponsor

China Meitan General Hospital

Collaborators

Marino Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02930967

Brief Title

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

Official Title

A Safety and Efficacy Study of Chimeric Switch Receptor Modified T Cells in Patients With Recurrent or Metastatic Malignant Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Meitan General Hospital

Collaborators

Marino Biotechnology Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent PD-L1+ Malignant Tumors, Metastatic PD-L1+ Malignant Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CSR T cells

Arm Type

Experimental

Arm Description

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 Type

Biological

Intervention Name(s)

autologous CSR T

Intervention Description

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 Measure Information:

Title

Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0.

Description

safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy

Time Frame

2 years

Secondary Outcome Measure Information:

Title

treatment response rate of CSR T cell infusion

Description

defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD).

Time Frame

4 weeks

Title

overall survival rate

Time Frame

2 years

Title

progression-free survival

Time Frame

6 months

Title

proliferation of CSR T cells in patients

Time Frame

2 years

Title

Persistence of CSR T cells in patients

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; measurable tumors by RECIST1.1 standard; patients are 18 to 70 years old; life expectancy > 3months; KPS ≥70; 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 ; Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L; 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: patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy active infection. HIV positive. active hepatitis B virus infection or hepatitis C virus infection. currently enrolled in other study. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study. patients with allergic disease, or are allergic to T cell products or other biological agents used in the study. patients whose tumors have metastasized to bone, or have clinical signs of bone metastasis, such as bone and joint pain. patients with brain metastasis, or have clinical signs of brain metastasis, such as loss of self-consciousness.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shidong Wei, MD

Phone

+86-13146634751

liqinghe9644679@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinwen Sun, MD

Organizational Affiliation

China Meitan General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

China Meitan General Hospital

City

Beijing

ZIP/Postal Code

100028

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shidong Wei, MD

Phone

+86-13146634751

liqinghe9644679@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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