A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

PHASE1SuspendedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

July 3, 2019

Primary Completion Date

August 12, 2022

Study Completion Date

August 12, 2022

Conditions
Solid Tumor
Interventions
BIOLOGICAL

NeoTCR-P1 adoptive cell therapy

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.

BIOLOGICAL

nivolumab

Nivolumab is a human IgG4 anti-PD-1 monoclonal antibody

BIOLOGICAL

IL-2

IL-2 is a biologic response modifier. It is a type of protein called a cytokine.

Trial Locations (9)

10065

Memorial Sloan Kettering Cancer Center, New York

37203

Tennessee Oncology, Nashville

60611

Northwestern University Medical Center, Chicago

90024

University of California, Los Angeles, Los Angeles

91010

City of Hope, Duarte

92868

University of California, Irvine Medical Center, Orange

94158

University of California, San Francisco, San Francisco

95817

University of California, Davis, Sacramento

98109

Fred Hutchinson Cancer Research Center, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PACT Pharma, Inc.

INDUSTRY