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| Name | Class |
|---|---|
| Nanjing University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cCTL experimental group | Experimental | The planned treatment duration for each patient in the clinical trial is 2-4 months, with one cycle lasting 1 month. Each cycle will include multiple intravenous infusions of cCTL (generally 4-10 times), with treatment frequency ranging from one to three times per week (based on individual patient conditions, as determined by the investigator). The dose for each infusion is 2-5x10^7 cCTL cells per kg of body weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cCTL treatment | Biological | Each patient undergoes clinical trial treatment for 2 to 4 months. One cycle lasts 1 month and includes multiple cCTL intravenous infusions, typically 4 to 10 times per cycle. The infusion frequency is 1 to 3 times per week, determined by the investigator based on the individual patient's condition. The dosage per infusion is 2-5 × 10⁷ cCTL cells/kg body weight, with slight adjustments based on the patient's safety profile at the investigator's discretion. Daily safety assessments are conducted throughout the treatment period, and efficacy evaluation is performed at the end of each monthly cycle to determine the continuation of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). ORR was defined as the percentage of participants who had a Complete Response (Disappearance of all target lesions) or a Partial Response (≥30% decrease in the sum of the longest diameter of target lesions) using RECIST 1.1 based on BICR. | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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 prior to enrollment);
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 HIV antibody; positive CMV DNA; positive for syphilis;
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, uncontrolled cerebrovascular disease;
Meeting any of the following heart-related standards:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Obstetrics and Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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