MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-MESO CAR-T cells
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring CAR-T, MESO, Ovarian Cancer, Relapsed and Refractory
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.
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
NCT ID
NCT03799913
First Posted
January 8, 2019
Last Updated
April 9, 2019
Sponsor
Zhejiang University
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hrain Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03799913
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2019 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hrain Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
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 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
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
CAR-T, MESO, Ovarian Cancer, Relapsed and Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
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
Intervention Description
Retroviral vector-transduced autologous T cells to express anti-MESO CARs
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
30mg/m2/d
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
300mg/m2/d
Primary Outcome Measure Information:
Title
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time Frame
1 years 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
86+057189713631
Email
zzg2011@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwei Zhou, M.D.
Organizational Affiliation
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
Jianwei Zhou, M.D.
Phone
0571-89713634
Email
jianwei-zhou@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
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