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

a study on Solid Tumor

Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Samuel Ejadi, MD

Description

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.

Official Title

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors

Keywords

Solid Tumor melanoma HR+ breast cancer ovarian cancer prostate cancer colorectal cancer urothelial carcinoma adoptive cell therapy neoantigen T cell receptor T lymphocyte TCR-engineered T cells personalized cell therapy cell therapy immunotherapy gene therapy PD-1 Neoplasms Nivolumab NeoTCR-P1 adoptive cell therapy NeoTCR-P1 NeoTCR-P1 plus nivolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist

  • Samuel Ejadi, MD
    Associate Clinical Professor, Medicine. Authored (or co-authored) 13 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PACT Pharma, Inc.
ID
NCT03970382
Phase
Phase 1
Study Type
Interventional
Last Updated