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

NCT07434284 | Recruiting Early Phase 1

• 1 other identifier: FUOBGY-2025-21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). ORR was defined as the percentage of participants who had a Complete Response (Disappearance of all target lesions) or a Partial Response (≥30% decrease in the sum of the longest diameter of target lesions) using RECIST 1.1 based on BICR.

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

cCTL experimental group

EXPERIMENTAL

The planned treatment duration for each patient in the clinical trial is 2-4 months, with one cycle lasting 1 month. Each cycle will include multiple intravenous infusions of cCTL (generally 4-10 times), with treatment frequency ranging from one to three times per week (based on individual patient conditions, as determined by the investigator). The dose for each infusion is 2-5x10\^7 cCTL cells per kg of body weight.

Biological: cCTL treatment

Interventions

cCTL treatment BIOLOGICAL

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.

cCTL experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• White blood cell count \< 3×10\^9/L, platelet count \< 80×10\^9/L;
• AST and ALT \> 3× upper limit of normal (ULN), total bilirubin \> 2× ULN, for liver metastasis patients, AST and ALT \> 6× ULN;
• Creatinine clearance \< 60 ml/min;
• Coagulation dysfunction;
• Active bacterial or fungal infections (≥ grade 2 of NCI-CTC, 3rd edition);
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \> 100 IU/mL; positive for hepatitis C antibody with peripheral blood HCV RNA positive; positive for HIV antibody; positive CMV DNA; positive for syphilis;
• Diseases deemed inappropriate for enrollment by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring drug treatment, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease;
• Meeting any of the following heart-related standards:
• Screening heart ultrasound shows left ventricular ejection fraction (LVEF) \< 50%;
• Screening ECG at rest shows QTcF \> 480 ms (female);
• Resting ECG shows any significant clinical arrhythmia, conduction, or morphological abnormalities (e.g., complete left bundle branch block, 2nd-3rd degree atrioventricular block, PR interval \> 250 ms);

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead
• Nanjing University: collaborator

Study Sites (1)

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: February 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)