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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • cCTL treatment

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators