OncoMatch/Clinical Trials/NCT05483491
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
Is NCT05483491 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including KK-LC-1 TCR-T cells and Aldesleukin for gastric cancer.
Treatment: KK-LC-1 TCR-T cells · Aldesleukin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Breast Carcinoma
Cervical Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: CT83 overexpression (≥ 10% of tumor cells positive by IHC) (≥ 10% of tumor cells positive by IHC)
Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay
Required: HLA-A A*01:01 allele
HLA-A*01:01 allele by HLA haplotype test
Excluded: HLA-A damaging mutation or allele loss or other molecular resistance
Subjects with HLA-A*01:01 damaging mutation or allele loss or other molecular resistance detected by clinical or research genomic profiling will not be eligible
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cancer type-specific standard of care systemic cancer therapy
Lab requirements
Blood counts
Leukocytes > 3,000/mcL; Absolute neutrophil count > 1,500/mcL; Platelets > 100,000/mcL; Hemoglobin > 9.0 g/dL.
Kidney function
Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by CKD-EPI equation).
Liver function
Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. Serum AST (SGOT)/ALT (SGPT) < 2.5 x ULN.
Cardiac function
Left ventricular ejection fraction ≥45% by echocardiogram or MUGA for patients 50 years of age or older.
Participants must have organ and marrow function as defined below: Leukocytes > 3,000/mcL; Absolute neutrophil count > 1,500/mcL; Platelets > 100,000/mcL; Hemoglobin > 9.0 g/dL; Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. Serum AST (SGOT)/ALT (SGPT) < 2.5 x ULN. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by CKD-EPI equation). Left ventricular ejection fraction ≥45% by echocardiogram or MUGA for patients 50 years of age or older.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital · New Brunswick, New Jersey
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