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OncoMatch/Clinical Trials/NCT02870244

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Is NCT02870244 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Escalating Doses for melanoma.

Phase 1RecruitingLoyola UniversityNCT02870244Data as of May 2026

Treatment: Escalating DosesPhase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.

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Extracted eligibility criteria

Cancer type

Melanoma

Biomarker criteria

Required: HLA-A2 positive

Required: TYR positive

Allowed: BRAF v600e

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: immunotherapy targeting tyrosinase

Patients that have undergone immunotherapy targeting tyrosinase.

Cannot have received: immunotherapy in combination with non-myeloablative chemotherapy

Patients that have undergone immunotherapy in combination with non-myeloablative chemotherapy.

Cannot have received: chemotherapy

Exception: within 4 weeks of study start

Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start.

Cannot have received: investigational treatment

Exception: within 4 weeks of study start

Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start.

Lab requirements

Blood counts

Absolute neutrophil count less than 1.5 x 10^9/L; Platelet count less than 100 x 10^9/L; International Normalized Ratio, INR greater than 1.5

Kidney function

Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault, less than 50mL min.

Liver function

Serum bilirubin greater than 1.5 x upper limit of normal ULN; Serum ALT, AST greater than 2.5 x ULN; Serum ALP greater than 2 x ULN; Serum Albumin less than 2.5 g dL

Cardiac function

Cardiac ejection fraction greater than 50 percent as determined by screening echocardiogram

Any of the following abnormal laboratory values Absolute neutrophil count less than 1.5 x 10^9/L Platelet count less than 100 x 10^9/L Serum bilirubin greater than 1.5 x upper limit of normal ULN Serum ALT, AST greater than 2.5 x ULN Serum ALP greater than 2 x ULN Serum Albumin less than 2.5 g dL International Normalized Ratio, INR greater than 1.5 Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault, less than 50mL min. Cardiac ejection fraction greater than 50 percent as determined by screening echocardiogram.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Loyola University Medical Center · Maywood, Illinois

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