KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristian Hinrichs
About this trial
This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.
Eligibility criteria
Qualifiers
Signed, written informed consent obtained prior to any study procedures.
Age ≥ 18 years at the time of informed consent.
Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers, screening will focus on gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by the Rutgers Cancer Institute, Department of Biorepository Services.
HLA-A*01:01 allele by HLA haplotype test.
Disqualifiers
Current treatment with another investigational agent.
History of severe allergic reactions to compounds of similar chemical or biologic composition to agents used in study.
History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.
Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or
Trial design
Treatments tested in this trial
- KK-LC-1 TCR-T cells
- Aldesleukin
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Christian Hinrichs
Lead sponsor
Rutgers, The State University of New Jersey
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Iovance Biotherapeutics, Inc.
Collaborator
Source ClinicalTrials.gov