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

April 12, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Safety and Effectiveness of MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer

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 epithelial ovarian cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The second affiliated hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time Frame: 12 months post infusion
12 months post infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time Frame: 12 months post infusion
12 months post infusion
Progress Free Survival (PFS) after administration
Time Frame: 12 months post infusion
12 months post infusion
Duration of CAR-positive T cells in circulation
Time Frame: 12 months post infusion
12 months post infusion
Detection of PD1 antibody in serum
Time Frame: 12 months post infusion
12 months post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Jianwei Zhou, M.D., Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2019

Primary Completion (Anticipated)

April 20, 2022

Study Completion (Anticipated)

April 20, 2023

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MESO-OS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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