cCTL plus immunotherapy for advanced gynecologic cancers

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

This trial will test whether injecting tumor-specific cytotoxic T lymphocytes (cCTL) together with immunotherapy helps people with advanced gynecologic cancers who have not responded to standard treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07434284 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label early phase 1 trial enrolling 5–20 patients with advanced ovarian, cervical, endometrial, or other gynecologic cancers who have failed standard treatments or declined further chemotherapy. Participants will receive tumor-specific cytotoxic T lymphocyte (cCTL) injections combined with an immunotherapy agent and will be closely monitored for safety, tolerability, and preliminary signs of tumor response. The study will collect blood and tumor samples to explore immunological changes and biomarkers associated with response. All treatments and follow-up visits are conducted at a single center in Shanghai.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed advanced ovarian, cervical, endometrial, or other gynecologic cancers who have failed standard treatments, have ECOG 0–2, life expectancy over 3 months, and can provide informed consent are ideal candidates.

Not a fit: Patients who received immunotherapy within the past 3 months, require immunosuppressive drugs, had chemotherapy/radiation or major surgery within the past month, or have other active cancers are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the combination could offer a new immunotherapy option that boosts the patient's immune system to attack gynecologic tumors and help people with few remaining options.

How similar studies have performed: Adoptive T cell therapies have produced major successes in blood cancers and early signals in some solid tumors, but tumor-specific cCTL combinations for gynecologic cancers remain largely experimental with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 75 years；
2. Histologically or cytologically confirmed diagnosis of advanced ovarian cancer, cervical cancer, endometrial cancer, or other gynecological malignancies;
3. Tumor patients with previous standard treatment failure, or those who refuse further chemotherapy, with a life expectancy of more than 3 months;
4. ECOG performance status of 0-2;
5. Patients of childbearing potential must use appropriate contraceptive methods (e.g., contraception or other methods of fertility control) before and during the trial;
6. Ability to understand the trial and have signed the informed consent form;
7. Ability to comply with the study protocol and follow-up procedures.

Exclusion Criteria:

1. Receipt of any form of immunotherapy within the past 3 months;
2. Required use of immunosuppressive agents;
3. Receipt of tumor chemotherapy, radiotherapy, or second-degree or higher surgery within the past month;
4. 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);
5. White blood cell count \< 3×10\^9/L, platelet count \< 80×10\^9/L;
6. AST and ALT \> 3× upper limit of normal (ULN), total bilirubin \> 2× ULN, for liver metastasis patients, AST and ALT \> 6× ULN;
7. Creatinine clearance \< 60 ml/min;
8. Coagulation dysfunction;
9. Active bacterial or fungal infections (≥ grade 2 of NCI-CTC, 3rd edition);
10. 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;
11. 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;
12. 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);
    * Presence of factors increasing the risk of QTc interval prolongation or arrhythmic events, such as heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, family history of long QT syndrome, or known medications that prolong QT intervals;
13. Pregnant or breastfeeding women; women of childbearing potential must test negative for pregnancy within 7 days prior to enrollment;
14. Drug abuse, clinical, psychological, or social factors that impair informed consent or study implementation；
15. Known allergy to the study drug;
16. Participation in other clinical trials within 1 month before enrollment;
17. Inability to undergo apheresis or inability to establish peripheral venous access;
18. Any uncertain factor that may affect the safety or compliance of the patient;
19. Other conditions considered unsuitable for enrollment by the investigator.

Where this trial is running

Shanghai, Shanghai Municipality

• The Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions Advanced Gynecological Cancers