The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer
NCT ID: NCT03814447
Last Updated: 2021-08-10
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
10 participants
INTERVENTIONAL
2019-08-16
2023-01-31
Brief Summary
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Detailed Description
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1\. To determine the safety and feasibility of anti- MESO CAR-T cells therapy for Refractory-Relapsed 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
3. To assess the quality of life in patients with ovarian cancer after treatment with 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
The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4\~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3).
anti- MESO CAR-T cells
Autologous genetically modified anti- MESO CAR transduced T cells
Fludarabine
Dose: 30mg/m2/d
Cyclophosphamide
Dose: 300mg/m2/d
Interventions
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anti- MESO CAR-T cells
Autologous genetically modified anti- MESO CAR transduced T cells
Fludarabine
Dose: 30mg/m2/d
Cyclophosphamide
Dose: 300mg/m2/d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18-75 Years Old, female;
3. Expected survival \> 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) score 0-2;
5. Patients who have previously been treated with second- line or above standard treatment are failed (progress in treatment or recurrence within 6 months after discontinuation of treatment);
6. According to the Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST) , there should be at least one measurable tumor foci；
7. Positive expression of Mesothelin in tumor tissue；
8. Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60ml / min;
9. alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN , such as with liver metastasis, ≤ 5×ULN;
10. Total bilirubin ≤ 2×ULN;
11. Hemoglobin≥90g/L(No blood transfusion within 14 days);
12. Absolute value of neutrophils ≥1.5×10\^9/L;
13. Absolute counting of lymphocytes \>0.7×10\^9/L;
14. Counting of Platelet≥80×10\^9/L；
15. The venous access required for collection can be established without contraindications for leukocyte collection;
16. Able to understand and sign the Informed Consent Document.
Exclusion Criteria
2. Active hepatitis B, hepatitis C, syphilis, HIV infection;
3. Insufficient function of important organs (heart, lung);
4. Any other uncontrolled active disease that impedes participation in the trial;
5. Any affairs could affect the safety of the subjects or purpose 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 within 14 days or 14 days prior to enrollment；
8. The investigator believes that it is not appropriate to participate in the trial;
9. Received CAR-T treatment or other gene therapies before enrollment; Subjects suffering disease affect the understanding of informed consent or unable to comply with study; Unwilling or unable to comply with study requirements.
18 Years
75 Years
FEMALE
No
Sponsors
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Hrain Biotechnology Co., Ltd.
INDUSTRY
Shanghai 6th People's Hospital
OTHER
Responsible Party
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Zhao Hui
professor
Principal Investigators
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Hui Zhao, doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai 6th People's Hospital
Locations
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Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 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-CART
Identifier Type: -
Identifier Source: org_study_id
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