T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

February 7, 2014

Primary Completion Date

March 24, 2021

Study Completion Date

March 24, 2021

Conditions
Cervical CancerRenal CancerUrothelial CancerMelanomaBreast Cancer
Interventions
BIOLOGICAL

Anti-MAGE-A3-DP4 T Cell Receptor (TCR) Peripheral Blood Lymphocytes (PBL)

Day 0: cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes

DRUG

Cyclophosphamide

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5 % in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hour.

DRUG

Fludarabine

Days -7 to -3: Fludarabine 25 mg/m\^2 /day intravenous piggy-back (IVPB) daily over 30 minutes for 5 days.

DRUG

Aldesleukin

Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02111850 - T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive | Biotech Hunter | Biotech Hunter