Spots Global Cancer Trial Database for A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors

Official Title: A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)

Study ID: NCT05576077

Conditions

Non-Small Cell Lung Cancer

Head and Neck Squamous Cell Carcinoma

Interventions

TBio-4101

Pembrolizumab

Study Description

Brief Summary: A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.

Detailed Description: This is a Phase 1 study to investigate TBio-4101. TBio-4101 is an autologous tumor infiltrating lymphocyte (TIL) therapy that utilizes tumor specific antigens to select, sort, and expand patient-specific tumor-reactive T-cells to be reinfused into the patient. The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion, followed by the TIL plus IL-2 infusion. Low-dose radiation therapy is administered prior to and after TIL plus IL-2 infusion. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.