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

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-MESO CAR-T cells
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, CAR-T, MESO, Relapsed and Refractory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-MESO CAR-T cells

Arm Description

Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients

Outcomes

Primary Outcome Measures

Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2019
Last Updated
April 12, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03916679
Brief Title
MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer
Official Title
Safety and Effectiveness of MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2019 (Anticipated)
Primary Completion Date
April 20, 2022 (Anticipated)
Study Completion Date
April 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 epithelial ovarian cancer.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian Cancer, CAR-T, MESO, Relapsed and Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-MESO CAR-T cells
Arm Type
Experimental
Arm Description
Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
Intervention Type
Biological
Intervention Name(s)
anti-MESO CAR-T cells
Other Intervention Name(s)
Fludarabine 30mg/m2/d, Cyclophosphamide 300mg/m2/d
Intervention Description
Retroviral vector-transduced autologous T cells to express anti-MESO CARs
Primary Outcome Measure Information:
Title
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time Frame
12 months post infusion
Secondary Outcome Measure Information:
Title
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time Frame
12 months post infusion
Title
Progress Free Survival (PFS) after administration
Time Frame
12 months post infusion
Title
Duration of CAR-positive T cells in circulation
Time Frame
12 months post infusion
Title
Detection of PD1 antibody in serum
Time Frame
12 months post infusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhigang Zhang, M.D.
Phone
15088621550
Email
zzg2011@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jianwei Zhou, M.D.
Phone
0571-89713634
Email
jianwei-zhou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwei Zhou, M.D.
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Zhang, M.D.
Phone
15088621550
Email
zzg2011@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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