An Early Phase 1 interventional study of cCTL treatment in Advanced Gynecological Cancers, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Early Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Meeting any of the following heart-related standards:
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.
Biological: cCTL treatment
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.
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.
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: No
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Obstetrics & Gynecology Hospital of Fudan University