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Brief Title: Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
Official Title: 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)
Study ID: NCT05628883
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Moffitt Cancer Center, Tampa, Florida, United States
Name: Amod Sarnaik, MD
Affiliation: Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR