Description:
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.
Title
- Brief Title: MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
- Official Title: A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
Clinical Trial IDs
- ORG STUDY ID:
MESO
- NCT ID:
NCT03799913
Conditions
Interventions
Drug | Synonyms | Arms |
---|
anti-MESO CAR-T cells | | anti-MESO CAR-T cells |
Fludarabine | | anti-MESO CAR-T cells |
Cyclophosphamide | | anti-MESO CAR-T cells |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
anti-MESO CAR-T cells | Experimental | Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients | - anti-MESO CAR-T cells
- Fludarabine
- Cyclophosphamide
|
Eligibility 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.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 |
Time Frame: | 1 years post infusion |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm |
Time Frame: | 12 months post infusion |
Safety Issue: | |
Description: | |
Measure: | Progress Free Survival (PFS) after administration |
Time Frame: | 12 months post infusion |
Safety Issue: | |
Description: | |
Measure: | Duration of CAR-positive T cells in circulation |
Time Frame: | 12 months post infusion |
Safety Issue: | |
Description: | |
Measure: | Detection of PD1 antibody in serum |
Time Frame: | 12 months post infusion |
Safety Issue: | |
Description: | |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Zhejiang University |
Trial Keywords
- CAR-T
- MESO
- Ovarian Cancer
- Relapsed and Refractory
Last Updated
April 10, 2019