CompletedPhase 1

Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma

United States17 participantsStarted 2022-11-22

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count ≥ 1,500/mcL (non-growth factor supported)
✓. Platelet count ≥ 100,000/mcL
✓. Hemoglobin ≥ 8.0 g/dL
✓. AST (SGOT)/ALT (SGPT) ≤ 3 times the institutional ULN; ≤ 5 times ULN if patient has liver metastasis
✓. Cockcroft-Gault estimated GFR ≥ 50 mL/min (creatinine)
✓. Total bilirubin ≤ 2.0 mg/dL (except in patients with Gilbert's Syndrome where the bilirubin must be ≤ 3 mg/dL)

What they're measuring

Percentage of Participants that Successfully Receive TBio-4101

Timeframe: Day 7

Trial details

NCT IDNCT05628883

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-03

View on ClinicalTrials.gov More Metastatic Melanoma trials