KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 26, 2022

Primary Completion Date

September 1, 2026

Study Completion Date

December 31, 2028

Conditions
Gastric CancerBreast CancerCervical CancerLung Cancer
Interventions
BIOLOGICAL

KK-LC-1 TCR-T cells

Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. KK-LC-1 TCR-T cells will be administered as a single intravenous infusion.

DRUG

Aldesleukin

Aldesleukin 720,000 IU/kg IV every 8 hours will be preferentially administered as an inpatient within 24 hours after KK-LC-1 TCR-T cell infusion for up to 6 doses; however up to 24 hours may elapse between doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion.

Trial Locations (2)

08901

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Iovance Biotherapeutics, Inc.

INDUSTRY

lead

Christian Hinrichs

OTHER