Advanced Gynecological CancersEarly Phase 1NCT07434284
Exploratory Clinical Study of cCTL in Combination With Immunotherapy for Advanced Gynecologic Malignancies
A Early Phase 1 study testing cCTL treatment in people with Advanced Gynecological Cancers, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Gynecological Cancers
- What is being tested?
- cCTL treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Dec 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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);
- 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;
- Pregnant or breastfeeding women; women of childbearing potential must test negative for pregnancy within 7 days prior to enrollment;
- Drug abuse, clinical, psychological, or social factors that impair informed consent or study implementation；
- Known allergy to the study drug;
- Participation in other clinical trials within 1 month before enrollment;
- Inability to undergo apheresis or inability to establish peripheral venous access;
- Any uncertain factor that may affect the safety or compliance of the patient;
- Other conditions considered unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality
Xin Wu, 8613764046908, wuxin_fc@fudan.edu.cn
About this study
Official title: Exploratory Clinical Study of Tumor-Specific Cytotoxic T Lymphocyte Injection (cCTL) in Combination With Immunotherapy for Advanced Gynecologic Malignancies
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
- Being tested
- cCTL treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cCTL treatmentBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: cCTL treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gynecological CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434284
- Sponsor's protocol ID
- FUOBGY-2025-21
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No