TIL Therapy for Metastatic Renal Cell Carcinoma

PHASE1CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

October 31, 2021

Study Completion Date

October 31, 2021

Conditions
Metastatic Renal Cell Carcinoma
Interventions
PROCEDURE

Surgical removal of tumor tissue for T cell production

Surgical removal of \> 1 cm3 tumor tissue chosen with regards to high rate of success and to minimize the general risks involved in a surgical procedure.

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.

DRUG

Fludarabine

Fludarabine 25 mg/m2 is administered on day -5 to day -1. Maximum dose of 50 mg per administration.

BIOLOGICAL

TIL infusion

The maximum number of expanded TILs are infused over 30-45 minutes on day 0.

DRUG

Interleukin-2

Interleukin-2 is administered as high-dose bolus infusions (600.000 IU/kg) over a 15 minute period every 8 hours and continuing for up to 5 days (maximum of 15 doses).

Trial Locations (1)

2730

Center for Cancer Immune Therapy Dept. of Hematology/oncology, Herlev

All Listed Sponsors
lead

Inge Marie Svane

OTHER

NCT02926053 - TIL Therapy for Metastatic Renal Cell Carcinoma | Biotech Hunter | Biotech Hunter