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

China Meitan General Hospital

Status and phase: Unknown; Phase 1

Conditions: Mesothelin Positive Tumors

Treatments: Biological: anti-mesothelin CAR T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02930993

K16-4

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

anti-mesothelin CAR T cells

Experimental group

Description:

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 .

Treatment:

Biological: anti-mesothelin CAR T cells