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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 22, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Metastatic MelanomaUnresectable MelanomaAcral MelanomaMucosal MelanomaCutaneous MelanomaOcular MelanomaUveal MelanomaIris MelanomaConjunctival MelanomaNon-Cutaneous Melanoma
Interventions
BIOLOGICAL

TBio-4101

TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell.

DRUG

Cyclophosphamide

Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days.

DRUG

Fludarabine

Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion

DRUG

Interleukin-2

Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion.

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

Turnstone Biologics, Corp.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER