BridgeMD
New treatment option for Gynecological Solid Tumors
Official title A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors
ClinicalTrials.gov ID: NCT06904131
What this study is testing
What is Cell therapy with bispecific antibodies?
Cell therapy with bispecific antibodies is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gynecological solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 researcher and the participant, the date of reinfusion (Day 0) is determined.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Patients with gynecological solid tumors diagnosed by histopathology, with tumor tissue sample MUC1 expression rate ≥50% or MSLN expression rate...
- Patients with advanced gynecological solid tumors who have failed standard treatment or are intolerant to such treatment and have no standard...
- Females aged 18 to 70 years (inclusive);
- Estimated survival time ≥ 3 months;
- ECOG performance status score of 0 to 1 at screening and baseline;
You likely can't join if
- Participants who have undergone other anti-tumor treatments not allowed by the protocol within 1 month before CAR-T infusion (including radiotherapy...
- Participants who have previously received targeted therapy against MUC1 or MSLN, or cellular therapy, or any gene therapy products (including CAR-T...
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.