Cancer Type: Cutaneous
Study Type: Treatment
Phase: Phase I
Principal Investigator: Sarnaik, Amod
A Proof of Concept Study of TBio-4101 (an autologous selected and expanded tumor infiltrating lymphocyte [TIL] therapy) using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients with Relapsed or Refractory Melanoma (Phase 1)
The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes [TIL]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma.
Primary Objective: Assess the feasibility, safety, and toxicity of TBio-4101 in patients that received banked or freshly collected TIL for the treatment of Cutaneous, mucosal or ocular melanoma. Secondary Objectives: Determine the Overall Response Rate (ORR) for each of the following cohorts: o Cutaneous (non-acral) melanoma receiving banked TIL o Cutaneous (non-acral) melanoma receiving freshly collected TIL o Cutaneous acral melanoma, mucosal melanoma, or ocular melanoma irrespective of when TIL were collected Evaluate duration of response (DoR) and progression free survival (PFS) in all patients using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) Determine the overall survival (OS) rate across all cohorts Compare the phenotype and tumor antigen reactivity of TBio-4101 generated from banked versus freshly collected TIL
Cell Therapy; Chemotherapy (NOS); Therapy (NOS)
Aldesleukin (Interleukin-2); TBio-4101 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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