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Brief Title: Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients With Advanced Solid Tumors
Official Title: Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients With Advanced Solid Tumors
Study ID: NCT05831033
Brief Summary: Multicenter, single arm, non-randomized, prospective, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (BEN101) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic solid tumor.
Detailed Description: BEN101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with recurrent and/or metastatic solid tumor. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
RenJi Hospital, Shanghai, Shanghai, China
Shanghai General Hospital, Shanghai, Shanghai, China
Name: Hongxia Wang, Doctor
Affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Wen Di, Doctor
Affiliation: RenJi Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Wei Xue, Doctor
Affiliation: RenJi Hospital
Role: PRINCIPAL_INVESTIGATOR