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Brief Title: Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer
Official Title: A Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer
Study ID: NCT05475847
Brief Summary: A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.
Detailed Description: For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District, Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area, Shanghai, Shanghai, China
Name: Xiaohua Wu, MD, Ph.D
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Jian Zhang, MD, Ph.D
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR