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RECRUITING
NCT02870244
PHASE1

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Sponsor: Loyola University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2015-02

Completion Date

2028-09

Last Updated

2018-03-12

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Escalating 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.

Locations (1)

Loyola University Medical Center

Maywood, Illinois, United States