Title
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
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
Phase
Phase 1Lead Sponsor
PACT Pharma, Inc.Study Type
InterventionalStatus
SuspendedIndication/Condition
Solid TumorIntervention/Treatment
NeoTCR-P1 adoptive cell therapy nivolumab ...Study Participants
21This 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.
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.
IL-2 is a biologic response modifier. It is a type of protein called a cytokine.
Single dose of NeoTCR-P1 plus nivolumab 480mg IV every four weeks for up to 6 doses.
Single dose of NeoTCR-P1 plus IL-2 500,000 IU/m2 SC twice daily (BID) for 7 days.
Inclusion Criteria: Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer. Disease has progressed after at least one available standard therapy or no additional curative therapies are available. Measurable disease per RECIST v1.1 Eastern cooperative oncology group (ECOG) performance status of 0 or 1 Adequate hematologic and end organ function determined within 30 days prior to enrollment. Disease-specific criteria related to the specific tumor type are required. Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria. Exclusion Criteria: Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases Uncontrolled or symptomatic hypercalcemia Pregnancy, lactation, or breastfeeding Prior allogeneic stem cell transplant or solid organ transplant Prior chimeric antigen receptor therapy or other genetically modified T cell therapy Active HIV, Hepatitis B, or Hepatitis C infection Active tuberculosis Severe infection within 2 weeks prior to enrollment Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study. Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.
