Status:
UNKNOWN
The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer
Lead Sponsor:
Shanghai 6th People's Hospital
Collaborating Sponsors:
Hrain Biotechnology Co., Ltd.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical trial is to study the safety and feasibility of anti- Mesothelin Chimeric Antigen Receptor T-Cell (MESO CAR-T cells) therapy for Refractory-Relapsed Ovarian Cancer
Detailed Description
Primary Objectives: 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- MES...
Eligibility Criteria
Inclusion
- Histopathologically confirmed ovarian cancer;
- 18-75 Years Old, female;
- Expected survival \> 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) score 0-2;
- 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);
- According to the Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST) , there should be at least one measurable tumor foci；
- Positive expression of Mesothelin in tumor tissue；
- Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60ml / min;
- alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN , such as with liver metastasis, ≤ 5×ULN;
- Total bilirubin ≤ 2×ULN;
- Hemoglobin≥90g/L(No blood transfusion within 14 days);
- Absolute value of neutrophils ≥1.5×10\^9/L;
- Absolute counting of lymphocytes \>0.7×10\^9/L;
- Counting of Platelet≥80×10\^9/L；
- The venous access required for collection can be established without contraindications for leukocyte collection;
- Able to understand and sign the Informed Consent Document.
Exclusion
- Accompanied by other uncontrolled malignant tumors;
- Active hepatitis B, hepatitis C, syphilis, HIV infection;
- Insufficient function of important organs (heart, lung);
- Any other uncontrolled active disease that impedes participation in the trial;
- Any affairs could affect the safety of the subjects or purpose 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 within 14 days or 14 days prior to enrollment；
- The investigator believes that it is not appropriate to participate in the trial;
- 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.
Key Trial Info
Start Date :
August 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03814447
Start Date
August 16 2019
End Date
January 1 2023
Last Update
August 10 2021
Active Locations (1)
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1
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China