Ovarian Cancer
Conditions
Keywords
CAR-T, MESO, Ovarian Cancer, Relapsed and Refractory
Brief summary
The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.
Detailed description
Primary Objectives 1.To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer. Secondary Objectives 1. To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer. 2. To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.
Interventions
DRUGFludarabine
30mg/m2/d
DRUGCyclophosphamide
300mg/m2/d
BIOLOGICALanti-MESO CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-MESO CARs
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hrain Biotechnology Co., Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 70 Years Old, female; 2. Expected survival \> 12 weeks; 3. Clinical performance status of ECOG score 0-2; 4. Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission); 5. At least one measurable tumor foci according to RECIST standard 1.1 ; 6. Positive Mesothelin expression in tumor tissues; 7. Creatinine ≤ 1.5×ULN; 8. ALT and AST ≤ 3×ULN; 9. Total bilirubin ≤ 2×ULN; 10. Hemoglobin≥90g/L; 11. Absolute counting of neutrophils≥1000uL ; 12. Absolute counting of lymphocytes\>0.7×10\^9/L; 13. Counting of Platelet≥75000/uL; 14. The venous access required for collection can be established without contraindications for leukocyte collection; 15. Able to understand and sign the Informed Consent Document.
Exclusion criteria
1. Accompanied by other uncontrolled malignant tumors; 2. Active hepatitis B, hepatitis C, syphilis, HIV infection; 3. Suffering severe cardiovascular or respiratory disease; 4. Any other diseases could affect the outcome of this trial; 5. Any affairs could affect the safety of the subjects or outcome of this trial; 6. Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment; 7. There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment; 8. Patients who are accounted by researchers to be not appropriate for this test; 9. Received CAR-T treatment or other gene therapies before assignment; 10. Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | 1 years post infusion |
Secondary
| Measure | Time frame |
|---|---|
| Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | 12 months post infusion |
| Progress Free Survival (PFS) after administration | 12 months post infusion |
| Duration of CAR-positive T cells in circulation | 12 months post infusion |
| Detection of PD1 antibody in serum | 12 months post infusion |
Countries
China
Contacts
Primary ContactZhigang Zhang, M.D.
Outcome results
None listed