T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

March 8, 2022

Primary Completion Date

July 16, 2025

Study Completion Date

July 16, 2025

Conditions
Kita-kyushu Lung Cancer Antigen 1, Human
Interventions
DRUG

IL-2 (Aldesleukin)

dose of 720,000 IU/kg (based on total body weight) as an intravenous bolus over a 15 minute period beginning within 24 hours of cell infusion and continuing for up to four days (maximum 12 doses).

DRUG

Cyclophosphamide

30 mg/kg IV infusion over 1 hour (+ 10 min) Once daily x 2 doses (Days -6 and -5)

BIOLOGICAL

KK-LC-1 TCR

1 x 108 transduced KK-LC-1 TCR T cells

DRUG

Fludarabine

25 mg/m2 IV infusion over 30 minutes (+ 10 min) To be administered following completion of cyclophosphamide. Once daily x 5 doses (Days -6, -5, -4, -3, -2)

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH