Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 27, 2019

Primary Completion Date

May 26, 2023

Study Completion Date

June 16, 2023

Conditions
Sarcoma
Interventions
DRUG

TIL

Participants will receive an infusion of Tumor-infiltrating lymphocytes (TIL) after tumor resection and TIL product is generated.

DRUG

Interleukin-2

Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously (IV) bolus (about 15 minutes) every 8 to 16 hours for up to 15 doses, beginning approximately 8 to 16 hours after T-cell infusion.

DRUG

Fludarabine

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

DRUG

Cyclophosphamide

Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL normal saline (NS) over approximately 2 hours, 7 days prior to T-Cell infusion

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa

Sponsors
All Listed Sponsors
collaborator

Iovance Biotherapeutics, Inc.

INDUSTRY

collaborator

The V Foundation for Cancer Research

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER