RWF_16-004

Adoptive T Cell Immunotherapy for Advanced Melanoma using Engineered Lymphocytes: a Phase 1b Study

This is a Phase 1 dose escalation study designed to find the highest dose of TIL 1383I TCR transduced T cells that can safely be given. Three cohorts of 3 patients will be treated with increasing doses of TIL 1383I TCR transduced T cells. Patients will be monitored clinically and immunologically for a year after infusion. Subjects in Cohort 1 will receive 7.5 X 10^6/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 2 will receive 2.5 x 10^7/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 3 will receive 7.5 x 10^7/kg TIL 1383I TCR transduced T cells.

Inclusion Criteria:

* Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically.

* Patients melanoma must be positive for both tyrosinase and HLA-A2 pathologic review from FNA, core or excisional biopsy of lesion.

* Cardiac ejection fraction greater than 50 percent as determined by screening echocardiogram.
Patients that have undergone treatment with anti-CTLA-4, Cytotoxic T-Lymphocyte Antigen 4, antibody must have at least 6 weeks from last dose of CTLA-4 antibody and evidence of tumor progression before they can be enrolled into this study.

* Patients that have undergone treatment with anti-PD-1, Programmed Death Receptor 1, Blockade or anti-PD-L1 antibody must have at least 4 weeks from last dose of antibody and evidence of tumor progression before they can be treated in this study.

* Patients with V600E mutations are eligible if they have failed an approved BRAF inhibitor or MEK inhibitor therapy or have refused treatment with an approved BRAF inhibitor or MEK inhibitor.
Patients treated with prior Interleukin-2 (IL-2) are eligible.

Phase Ib
NCT02870244
Cancer, All Other
Cutaneous (skin), Melanoma
Brendan Curti, M.D.
Loyola University Chicago
Chris Fountain
  • Oncology and Hematology Care Eastside