Actively Recruiting
Exploratory Clinical Study of cCTL in Combination With Immunotherapy for Advanced Gynecologic Malignancies
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2026-02-25
20
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
O
Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor
N
Nanjing University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Exploratory Clinical Study of cCTL in Combination With Immunotherapy for Advanced Gynecologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Confirmed diagnosis of advanced ovarian, cervical, endometrial, or other gynecological cancers
- Previous standard treatment failure or refusal of further chemotherapy, with life expectancy over 3 months
- ECOG performance status of 0 to 2
- Use of effective contraception if of childbearing potential before and during the trial
- Ability to understand the trial and provide informed consent
- Ability to follow the study protocol and attend follow-up visits
You will not qualify if you...
- Received any immunotherapy within the last 3 months
- Need for immunosuppressive drugs
- Underwent chemotherapy, radiotherapy, or major surgery within the past month
- History of other cancers except certain treated cancers or those treated at least 5 years ago
- Low white blood cell count (< 3 x 10^9/L) or low platelet count (< 80 x 10^9/L)
- Liver enzyme levels (AST, ALT) above specified limits or elevated bilirubin
- Reduced kidney function (creatinine clearance < 60 ml/min)
- Blood clotting disorders
- Active bacterial or fungal infections of grade 2 or higher
- Positive tests for hepatitis B, hepatitis C, HIV, CMV, or syphilis infections
- Severe liver, kidney, metabolic, heart, or lung diseases or uncontrolled conditions
- Heart ultrasound or ECG abnormalities including low ejection fraction, prolonged QTc interval, arrhythmias
- Pregnancy or breastfeeding; negative pregnancy test required before enrollment
- Drug abuse or factors impairing consent or study participation
- Allergy to the study drug
- Participation in other clinical trials within 1 month
- Inability to undergo apheresis or establish venous access
- Any conditions that may affect safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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