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

NCT02930993 | Unknown Phase 1

• 1 other identifier: K16-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• safety of infusion of autologous anti-mesothelin CAR T cells as assessed by the incidents of treatment related adverse events per NCI CTCAE V4.0

  incidents of treatment related adverse events per NCI CTCAE V4.0

  2 years

Secondary Outcomes (6)

• treatment response rate of anti-mesothelin CAR T cells

  4 weeks

• progression free survival

  6 months

• overall survival

  2 years

• proliferation of anti-mesothelin CAR T cells in patients

  6 months

• activation of anti-mesothelin CAR T cells in patients

  6 months

Study Arms (1)

anti-mesothelin CAR T cells

EXPERIMENTAL

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 .

Biological: anti-mesothelin CAR T cells

Interventions

anti-mesothelin CAR T cells 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%).

anti-mesothelin CAR T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with mesothelin positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic adenocarcinoma, ovarian cancer, or pleural mesothelioma.
• relapsed or metastatic after standard treatment
• 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.

You may not qualify if:

• 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 who have allergic disease, or are allergic to T cell products or other biological agents used in the study.
• patients whose tumors have metastasized to bone marrow, or have clinical signs of bone metastasis, such as bone and joint pain .
• patients who have brain metastasis or signs of brain metastasis, such as loss of self-consciousness.

Sponsors & Collaborators

• China Meitan General Hospital: lead
• Marino Biotechnology Co., Ltd.: collaborator

Study Sites (1)

China Meitan General Hospital

Beijing, 100028, China

RECRUITING

Study Officials

• Jinwen Sun, MD

  China Meitan General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shidong Wei, MD

CONTACT

+86-13146634751; liqinghe9644679@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Department of General Surgery and Surgical Oncology

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

CN (1)