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

Study Overview
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Brief Summary
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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
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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 To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer. To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.

Official Title
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A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Biological: anti-MESO CAR-T cells
* Drug: Fludarabine
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-MESO CAR-T cells<br>Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients | Biological: anti-MESO CAR-T cells<br>* Retroviral vector-transduced autologous T cells to express anti-MESO CARs<br>Drug: Fludarabine<br>* 30mg/m2/d<br>Drug: Cyclophosphamide<br>* 300mg/m2/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 |  | 1 years post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T, MESO, Ovarian Cancer, Relapsed and Refractory