MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
NCT ID: NCT03799913
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2019-04-10
2022-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anti-MESO CAR-T cells
Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
anti-MESO CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-MESO CARs
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Interventions
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anti-MESO CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-MESO CARs
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Hrain Biotechnology Co., Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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Zhigang Zhang
Dr
Principal Investigators
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Jianwei Zhou, M.D.
Role: STUDY_CHAIR
Zhejiang University
Locations
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The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MESO
Identifier Type: -
Identifier Source: org_study_id
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