SuspendedPhase 1NCT03970382

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

StatusSuspended
PhasePhase 1
U.S. locations9
SponsorPACT Pharma, Inc.
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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