Anti-mesothelin CAR T Cells for Patients With Recurrent or Metastatic Malignant Tumors

NCT ID: NCT02930993

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-08-31

Brief Summary

This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or metastatic malignant tumors.

Conditions

Mesothelin Positive Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anti-mesothelin CAR T cells

Dose escalation study aimed to assess the safety and efficacy of anti-mesothelin CAR T cells.

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

Group Type: EXPERIMENTAL

anti-mesothelin CAR T cells

Intervention Type: BIOLOGICAL

Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, patients are intravenously infused with anti-mesothelin CAR T cells in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).

Interventions

anti-mesothelin CAR T cells

Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, patients are intravenously infused with anti-mesothelin CAR T cells in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. patients with mesothelin positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic adenocarcinoma, ovarian cancer, or pleural mesothelioma.

2. relapsed or metastatic after standard treatment

3. measurable tumors by RECIST1.1 standard

4. patients are 18 to 70 years old.

5. life expectancy > 3months.

6. KPS ≥70.

7. 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 .

8. Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L.

9. 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 who have 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 marrow, or have clinical signs of bone metastasis, such as bone and joint pain .

9. patients who have brain metastasis or signs of brain metastasis, such as loss of self-consciousness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marino Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

China Meitan General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinwen Sun

director of Department of General Surgery and Surgical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinwen Sun, MD

Role: PRINCIPAL_INVESTIGATOR

China Meitan General Hospital

Locations

China Meitan General Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shidong Wei, MD

Role: CONTACT

liqinghe9644679@163.com

+86-13146634751

Facility Contacts

Shidong Wei, MD

Role: primary

liqinghe9644679@163.com

+86-13146634751

Other Identifiers

K16-4

Identifier Type: -

Identifier Source: org_study_id