MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborators: Hrain Biotechnology Co., Ltd.; Hrain Biotechnology Co.,Ltd.; Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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.