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New treatment option for Advanced Gynecological Cancers
Official title Exploratory Clinical Study of cCTL in Combination With Immunotherapy for Advanced Gynecologic Malignancies
ClinicalTrials.gov ID: NCT07434284
What this study is testing
What is cCTL treatment?
cCTL treatment is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced gynecological cancers.
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
- This study is a single-arm, open-label, interventional, and exploratory clinical trial,the goal of which is to evaluate the safety and clinical efficacy of the novel tumor-specific cytotoxic T lymphocyte (cCTL) injection in combination with immunotherapy for the treatment of advanced gynecologic malignancies.The trial will also explore the preliminary efficacy and immunological characteristics of this therapy in a small sample of patients. 5-20 participants will be enrolled.
- Phase 1: an early, usually small safety study
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 75, women only
You may be able to join if
- Age between 18 and 75 years；
- Histologically or cytologically confirmed diagnosis of advanced ovarian cancer, cervical cancer, endometrial cancer, or other gynecological...
- Tumor patients with previous standard treatment failure, or those who refuse further chemotherapy, with a life expectancy of more than 3 months;
- ECOG performance status of 0-2;
- Patients of childbearing potential must use appropriate contraceptive methods (e.g., contraception or other methods of fertility control) before and...
You likely can't join if
- Receipt of any form of immunotherapy within the past 3 months;
- Required use of immunosuppressive agents;
- Receipt of tumor chemotherapy, radiotherapy, or second-degree or higher surgery within the past month;
- History of other cancers, except for in situ cervical cancer, treated squamous cell carcinoma, or bladder epithelial tumors (Ta and TIS), or other...
- White blood cell count \< 3×10\^9/L, platelet count \< 80×10\^9/L;
- AST and ALT \> 3× upper limit of normal (ULN), total bilirubin \> 2× ULN, for liver metastasis patients, AST and ALT \> 6× ULN;
See the full eligibility criteria
- Age between 18 and 75 years；
- Histologically or cytologically confirmed diagnosis of advanced ovarian cancer, cervical cancer, endometrial cancer, or other gynecological malignancies;
- Tumor patients with previous standard treatment failure, or those who refuse further chemotherapy, with a life expectancy of more than 3 months;
- ECOG performance status of 0-2;
- Patients of childbearing potential must use appropriate contraceptive methods (e.g., contraception or other methods of fertility control) before and during the trial;
- Ability to understand the trial and have signed the informed consent form;
- Ability to comply with the study protocol and follow-up procedures.
- Receipt of any form of immunotherapy within the past 3 months;
- Required use of immunosuppressive agents;
- Receipt of tumor chemotherapy, radiotherapy, or second-degree or higher surgery within the past month;
- History of other cancers, except for in situ cervical cancer, treated squamous cell carcinoma, or bladder epithelial tumors (Ta and TIS), or other malignancies that have undergone radical treatment (at least 5 years...
- White blood cell count \< 3×10\^9/L, platelet count \< 80×10\^9/L;
- AST and ALT \> 3× upper limit of normal (ULN), total bilirubin \> 2× ULN, for liver metastasis patients, AST and ALT \> 6× ULN;
- Creatinine clearance \< 60 ml/min;
- Coagulation dysfunction;
- Active bacterial or fungal infections (≥ grade 2 of NCI-CTC, 3rd edition);
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \> 100 IU/mL; positive for hepatitis C antibody with peripheral blood HCV RNA positive; positive for...
- Diseases deemed inappropriate for enrollment by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring drug treatment, uncontrolled coronary artery disease or asthma...
- Meeting any of the following heart-related standards:
- Screening heart ultrasound shows left ventricular ejection fraction (LVEF) \< 50%;
- Screening ECG at rest shows QTcF \> 480 ms (female);
- Resting ECG shows any significant clinical arrhythmia, conduction, or morphological abnormalities (e.g., complete left bundle branch block, 2nd-3rd degree atrioventricular block, PR interval \> 250 ms);
- Presence of factors increasing the risk of QTc interval prolongation or arrhythmic events, such as heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, family history of long QT syndrome, or known...
- Pregnant or breastfeeding women; women of childbearing potential must test negative for pregnancy within 7 days prior to enrollment;
- Drug abuse, clinical, psychological, or social factors that impair informed consent or study implementation；
- Known allergy to the study drug;
- Participation in other clinical trials within 1 month before enrollment;
- Inability to undergo apheresis or inability to establish peripheral venous access;
- Any uncertain factor that may affect the safety or compliance of the patient;
- Other conditions considered unsuitable for enrollment 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 75 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.