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RECRUITING
NCT07434284
EARLY_PHASE1

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

Sponsor: Obstetrics & Gynecology Hospital of Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-02

Completion Date

2028-12

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China