RecruitingEarly Phase 1NCT07434284

Exploratory Clinical Study of cCTL in Combination With Immunotherapy for Advanced Gynecologic Malignancies

Exploratory Clinical Study of Tumor-Specific Cytotoxic T Lymphocyte Injection (cCTL) in Combination With Immunotherapy for Advanced Gynecologic Malignancies


Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

20 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called cCTL treatment for people with advanced gynecological cancers. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALcCTL 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.


Locations(1)

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT07434284