A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With 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.
Checked against the public recordLast updated Aug 18, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- PACT Pharma, Inc.
- Interventions being studied
- Biological: NeoTCR-P1 adoptive cell therapy; Biological: nivolumab; Biological: IL-2
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- University of California, Los AngelesLos Angeles, California
- University of California, Irvine Medical CenterOrange, California
- University of California, DavisSacramento, California
- University of California, San FranciscoSan Francisco, California
- Northwestern University Medical CenterChicago, Illinois
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Tennessee OncologyNashville, Tennessee
- Fred Hutchinson Cancer Research CenterSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2022. Always confirm current availability with the study team.