Status:
UNKNOWN
MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hrain Biotechnology Co., Ltd.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-70 years
Phase:
EARLY_PHASE1
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-M...
Eligibility Criteria
Inclusion
- 18 to 70 Years Old, female;
- Expected survival \> 12 weeks;
- Clinical performance status of ECOG score 0-2;
- Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission);
- At least one measurable tumor foci according to RECIST standard 1.1 ;
- Positive Mesothelin expression in tumor tissues;
- Creatinine ≤ 1.5×ULN;
- ALT and AST ≤ 3×ULN;
- Total bilirubin ≤ 2×ULN;
- Hemoglobin≥90g/L;
- Absolute counting of neutrophils≥1000uL ;
- Absolute counting of lymphocytes\>0.7×10\^9/L;
- Counting of Platelet≥75000/uL;
- The venous access required for collection can be established without contraindications for leukocyte collection;
- Able to understand and sign the Informed Consent Document.
Exclusion
- Accompanied by other uncontrolled malignant tumors;
- Active hepatitis B, hepatitis C, syphilis, HIV infection;
- Suffering severe cardiovascular or respiratory disease;
- Any other diseases could affect the outcome of this trial;
- Any affairs could affect the safety of the subjects or outcome of this trial;
- Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment;
- 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;
- Patients who are accounted by researchers to be not appropriate for this test;
- Received CAR-T treatment or other gene therapies before assignment;
- Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03799913
Start Date
April 10 2019
End Date
April 1 2022
Last Update
April 10 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009