NCT07434284

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Gynecological Cancers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: China