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

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.

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.