Exploratory Clinical Study of cCTL in Combination With Immunotherapy for Advanced Gynecologic Mal… (NCT07434284) | Clinical Trial Compass
RecruitingEarly Phase 1
Exploratory Clinical Study of cCTL in Combination With Immunotherapy for Advanced Gynecologic Malignancies
China20 participantsStarted 2026-02
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion 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.
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);
✕
What they're measuring
1
Objective response rate (ORR)
Timeframe: From enrollment to the end of treatment at 8 weeks
Trial details
NCT IDNCT07434284
SponsorObstetrics & Gynecology Hospital of Fudan University