A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNeoTCR-P1 adoptive cell therapy and nivolumab

Plus 1 other study approaches.

Who it may be forSolid Tumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 18, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Suspended

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?PACT Pharma, Inc.

Study sponsor

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

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How this study is categorized

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

Treatment approach

Immunotherapy→Cell or gene therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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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