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NCT03970382

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors

Study Summary

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.

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Interventions

NeoTCR-P1 adoptive cell therapyBIOLOGICAL
The investigational agent in this protocol is NeoTCR P1, an autologous adoptive T cell therapy (ACT) for patients with solid cancer. NeoTCR P1 is composed of apheresis derived CD8 and CD4 T cells that are precision genome engineered to express one autologous TCR of native sequence that targets a neoepitope (neoE) presented by human leukocyte antigen (HLA) receptors exclusively on the surface of that patient's tumor cells and not on other cells in the body.
nivolumabBIOLOGICAL
Nivolumab is a human IgG4 anti-PD-1 monoclonal antibody
IL-2BIOLOGICAL
IL-2 is a biologic response modifier. It is a type of protein called a cytokine.

Study Locations

FacilityCityStateCountry
City of HopeDuarteCaliforniaUnited States
University of California, Los AngelesLos AngelesCaliforniaUnited States
University of California, Irvine Medical CenterOrangeCaliforniaUnited States
University of California, DavisSacramentoCaliforniaUnited States
University of California, San FranciscoSan FranciscoCaliforniaUnited States
Northwestern University Medical CenterChicagoIllinoisUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Tennessee OncologyNashvilleTennesseeUnited States
Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026