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RecruitingNCT07434284Updated Feb 25, 2026

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

An Early Phase 1 interventional study of cCTL treatment in Advanced Gynecological Cancers, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Advanced Gynecological Cancers
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    cCTL experimental group

    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

  • BiologicalcCTL 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.

05

What researchers measure

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.

    Time frame: From enrollment to the end of treatment at 8 weeks

06

Study locations

1 of 1 sites recruiting
  • The Obstetrics and Gynecology Hospital of Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07434284
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborators
Nanjing University
Responsible party
Sponsor
First posted
Feb 25, 2026
Start date
Feb 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Feb 25, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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