RecruitingPhase 1NCT02870244

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes: A Phase 1b Study

Sponsor

Loyola University

Enrollment

18 participants

Start Date

Feb 1, 2015

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

Phase 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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of immune cell therapy for advanced melanoma (skin cancer that has spread), where patients' own immune cells are engineered in a lab to better find and attack cancer cells before being given back to the patient. **You may be eligible if...** - You have been diagnosed with advanced melanoma that has spread (metastatic melanoma) - You are 18 years of age or older - You are in good physical condition (able to perform normal daily activities) - Your cancer can be measured or seen on scans **You may NOT be eligible if...** - You are younger than 18 years - You are in poor overall physical health - Your cancer cannot be measured or tracked This is an experimental therapy — researchers are studying whether engineered immune cells can safely and effectively treat melanoma that has spread. Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEscalating Doses

Subjects will receive a single infusion of autologous bulk TIL 13831 TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 13831 TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4 + and CD8+ T Cells expressing the TIL 13831 TCR. 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.