Status:
RECRUITING
A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors
Lead Sponsor:
Obstetrics & Gynecology Hospital of Fudan University
Conditions:
Gynecological Solid Tumors
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the status of cell preparation and mutual agreement between the researche...
Detailed Description
This study is a single-arm, open-label, dose-escalation and expansion clinical trial. The study is divided into two phases: the dose-escalation phase and the dose-expansion phase. The dose-escalation...
Eligibility Criteria
Inclusion
- inclusion criteria
- Patients with gynecological solid tumors diagnosed by histopathology, with tumor tissue sample MUC1 expression rate ≥50% or MSLN expression rate ≥50%, PD-L1 positive expression, and sample source within 2 years;
- Patients with advanced gynecological solid tumors who have failed standard treatment or are intolerant to such treatment and have no standard effective treatment options;
- Females aged 18 to 70 years (inclusive);
- Estimated survival time ≥ 3 months;
- ECOG performance status score of 0 to 1 at screening and baseline;
- Good organ and bone marrow function:
- The researcher assesses sufficient bone marrow function to receive lymphocyte-depleting chemotherapy: Neutrophil count ≥1.5 × 10\^9/L, lymphocyte count ≥0.5 × 10\^9/L;
- Platelet count ≥90 × 10\^9/L;
- Hemoglobin ≥90 g/L (no blood transfusion or no erythropoietin-dependent within 7 days);
- Total bilirubin ≤2 times the upper limit of normal value;
- Serum creatinine ≤1.5 times the upper limit of normal value;
- Transaminase (AST, ALT) ≤2.5 times the upper limit of normal value (if liver metastasis is present, 5 times the upper limit of normal value);
- International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5 times the upper limit of normal value;
- Pulmonary function: ≤ CTCAE grade 1 dyspnea and SaO2 ≥ 91% in room air;
- Cardiac function: Echocardiogram or radionuclide ventriculography (MUGA) assessment left ventricular ejection fraction (LVEF) ≥50% within 1 month of enrollment.
- exclusion criteria
- Participants who have undergone other anti-tumor treatments not allowed by the protocol within 1 month before CAR-T infusion (including radiotherapy, chemotherapy, small molecules, biological treatment, or immunotherapy, other research drugs);
- Participants who have previously received targeted therapy against MUC1 or MSLN, or cellular therapy, or any gene therapy products (including CAR-T cell therapy) or any T cell therapy at home or abroad;
- Pregnant or breastfeeding women;
- AIDS virus, syphilis seroreactivity positive; hepatitis B surface antigen positive, or hepatitis B core antibody positive and hepatitis B virus DNA copies higher than the detection limit or greater than or equal to 1000 copies/mL; or hepatitis C virus infection;
- Any uncontrollable active infection, coagulopathy, or any other major disease;
- Patients with active autoimmune diseases being treated, organ transplantation and other immune-related diseases, or long-term use of immunosuppressive drugs such as glucocorticoids: a. Glucocorticoids cannot be discontinued within 72 hours before CAR-T cell infusion; b. Immunosuppressive agents other than glucocorticoids cannot be discontinued ≥4 weeks before enrollment;
- Patients with severe cardiopulmonary insufficiency, uncontrolled hypertension, any of the following cardiovascular disease histories within the past 6 months: III or IV heart failure defined by the New York Heart Association (NYHA), cardiac catheterization or stent, myocardial infarction, unstable angina, or other clinically significant heart disease;
- Patients with confirmed brain metastasis, or those with a history of or current central nervous system disease, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, encephalopathy, or any autoimmune disease associated with the central nervous system;
- Patients with high risk of bleeding or perforation;
- Patients who underwent major surgery or significant trauma within 4 weeks before single collection;
- Patients with other malignant tumors within 3 years or concurrently (except for skin basal cell carcinoma, cervical/breast cancer in situ, etc.);
- Any other conditions deemed unsuitable for participation in the study by the investigator.
Exclusion
Key Trial Info
Start Date :
May 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06904131
Start Date
May 11 2025
End Date
December 31 2027
Last Update
April 1 2025
Active Locations (1)
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1
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200090