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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
KK-LC-1 TCR-T cells
Biological/VaccineParticipants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. KK-LC-1 TCR-T cells will be administered as a single intravenous infusion.
Aldesleukin
DrugAldesleukin 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: KK-LC-1 TCR-T cellsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells
The highest dose level achieved according to the protocol-defined criteria for DLTs and determination of MTD.
Time frame
30 daysSecondary outcomes
1
Adverse events of KK-LC-1 TCR T cells
Adverse event determination as measured by National Cancer Institute (NCI) Common 5.0Terminology Criteria for Adverse Events (CTCAE) Criteria Version 5.0
Time frame
30 days2
Tumor response rate
Tumor response will be determined by RECIST criteria as per the protocol description
Time frame
6 weeks3
Tumor response duration
Tumor response duration will be determined by RECIST criteria as per the protocol description
Time frame
Through study completion, up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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