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

Early Phase 1

• Conditions: Ovarian Cancer
• Interventions: Biological: anti-MESO CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT03799913
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Study Start: 2019-04-10
• Last Update Posted: 2019-04-10
• Primary Completion: 2021-10
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-MESO CAR-T cells	anti-MESO CAR-T cells	Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
anti-MESO CAR-T cells	Cyclophosphamide	Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
anti-MESO CAR-T cells	Fludarabine	Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients

Primary Outcome Measures

Name	Time	Method
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0	1 years post infusion

Secondary Outcome Measures

Name	Time	Method
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
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm	12 months post infusion

Trial Locations

Locations (1)

The Second Affiliated hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China