A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
Trial Status: Active
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.
- 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.
- 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.
City of Hope Comprehensive Cancer Center
UCLA / Jonsson Comprehensive Cancer Center
Contact: Louis Slonlker
UC Irvine Health / Chao Family Comprehensive Cancer Center
University of California Davis Comprehensive Cancer Center
UCSF Medical Center-Mount Zion
Contact: Helen Diller Family Comprehensive Cancer Center
Memorial Sloan Kettering Cancer Center
Contact: Adam Schoenfeld
Fred Hutch / University of Washington Cancer Consortium
Trial Phase Phase I
Trial Type Treatment
PACT Pharma, Inc.
- Primary ID PACT-0101
- Secondary IDs NCI-2019-03772
- Clinicaltrials.gov ID NCT03970382