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

Part of paid clinical trials in Duarte, California.

Sponsor
PACT Pharma, Inc.
Study ID
NCT03970382
Phase
PHASE1
Status
Suspended

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NeoTCR-P1 adoptive cell therapy — BIOLOGICAL
    The investigational agent in this protocol is NeoTCR P1, an autologous adoptive T cell therapy (ACT) for patients with solid cancer. NeoTCR P1 is composed of apheresis derived CD8 and CD4 T cells that are precision genome engineered to express one autologous TCR of native sequence that targets a neoepitope (neoE) presented by human leukocyte antigen (HLA) receptors exclusively on the surface of that patient's tumor cells and not on other cells in the body.
  • nivolumab — BIOLOGICAL
    Nivolumab is a human IgG4 anti-PD-1 monoclonal antibody
  • IL-2 — BIOLOGICAL
    IL-2 is a biologic response modifier. It is a type of protein called a cytokine.

Study Details

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.

Key Dates

Start date
Jul 3, 2019
Status verified
Aug 2022
Primary completion
Aug 12, 2022
Completion
Aug 12, 2022

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NeoTCR-P1
    Single dose of NeoTCR-P1
  • Experimental: NeoTCR-P1 plus nivolumab
    Single dose of NeoTCR-P1 plus nivolumab 480mg IV every four weeks for up to 6 doses.
  • Experimental: NeoTCR-P1 plus IL-2
    Single dose of NeoTCR-P1 plus IL-2 500,000 IU/m2 SC twice daily (BID) for 7 days.

Primary Outcome Measure

Incidence of adverse events as defined as DLTs [ Time Frame: 28 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California, Los AngelesLos AngelesCalifornia90024-
University of California, Irvine Medical CenterOrangeCalifornia92868-
University of California, DavisSacramentoCalifornia95817-
University of California, San FranciscoSan FranciscoCalifornia94158-
Northwestern University Medical CenterChicagoIllinois60611-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Tennessee OncologyNashvilleTennessee37203-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of California, Irvine Medical Center· Orange, CAUniversity of California, Davis· Sacramento, CAUniversity of California, San Francisco· San Francisco, CANorthwestern University Medical Center· Chicago, IL

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