A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors

Launched by OBSTETRICS & GYNECOLOGY HOSPITAL OF FUDAN UNIVERSITY · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CAR-T cell therapy for women with advanced gynecological solid tumors, which are types of cancers that start in the female reproductive system. The goal is to see if this therapy can be safe and effective for patients who have not responded to standard treatments or have no other effective options available. To participate, women aged 18 to 70 years old with specific tumor characteristics, such as certain proteins in their cancer cells, and who have good overall health may be eligible.

Participants in the trial will go through a series of steps, starting with preparation of their own immune cells. They will then receive a special chemotherapy treatment to help their body accept the CAR-T cells, followed by the reinfusion of these modified immune cells. After the treatment, they will be monitored for safety and effectiveness over a period of time. Participants can expect regular check-ups, including visits every three months and annual follow-ups, to assess their health and response to the therapy. It's important for potential participants to discuss with their doctor whether they meet the eligibility criteria and if this trial is the right option for them.

Gender

FEMALE

Eligibility criteria

• • inclusion criteria
• • 1. 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;
• • 2. Patients with advanced gynecological solid tumors who have failed standard treatment or are intolerant to such treatment and have no standard effective treatment options;
• • 3. Females aged 18 to 70 years (inclusive);
• • 4. Estimated survival time ≥ 3 months;
• • 5. ECOG performance status score of 0 to 1 at screening and baseline;
• 6. Good organ and bone marrow function:
• • 1. 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;
• • 2. Platelet count ≥90 × 10\^9/L;
• • 3. Hemoglobin ≥90 g/L (no blood transfusion or no erythropoietin-dependent within 7 days);
• • 4. Total bilirubin ≤2 times the upper limit of normal value;
• • 5. Serum creatinine ≤1.5 times the upper limit of normal value;
• • 6. 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);
• • 7. International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5 times the upper limit of normal value;
• • 8. Pulmonary function: ≤ CTCAE grade 1 dyspnea and SaO2 ≥ 91% in room air;
• • 9. Cardiac function: Echocardiogram or radionuclide ventriculography (MUGA) assessment left ventricular ejection fraction (LVEF) ≥50% within 1 month of enrollment.
• • exclusion criteria
• • 1. 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);
• • 2. 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;
• • 3. Pregnant or breastfeeding women;
• • 4. 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;
• • 5. Any uncontrollable active infection, coagulopathy, or any other major disease;
• • 6. 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;
• • 7. 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;
• • 8. 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;
• • 9. Patients with high risk of bleeding or perforation;
• • 10. Patients who underwent major surgery or significant trauma within 4 weeks before single collection;
• • 11. Patients with other malignant tumors within 3 years or concurrently (except for skin basal cell carcinoma, cervical/breast cancer in situ, etc.);
• • 12. Any other conditions deemed unsuitable for participation in the study by the investigator.