Clinical Trials /

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

NCT03799913

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.

Related Conditions:
  • Ovarian Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

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

  • Ovarian Cancer

Interventions

DrugSynonymsArms
anti-MESO CAR-T cellsanti-MESO CAR-T cells
Fludarabineanti-MESO CAR-T cells
Cyclophosphamideanti-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

NameTypeDescriptionInterventions
anti-MESO CAR-T cellsExperimentalAdministration 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:Not yet recruiting
Lead Sponsor:Zhejiang University

Trial Keywords

  • CAR-T
  • MESO
  • Ovarian Cancer
  • Relapsed and Refractory

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