This study is currently not accepting new patients, but might later

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

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSF
Dates
study started
estimated completion

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, non-small cell lung cancer, head and neck squamous carcinoma, HER2 negative breast cancer, triple negative breast cancer, IL-2, Neoplasms, Aldesleukin, Nivolumab, Interleukin-2, NeoTCR-P1 adoptive cell therapy, NeoTCR-P1, NeoTCR-P1 plus nivolumab, NeoTCR-P1 plus IL-2

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, Los Angeles
    Los Angeles California 90024 United States
  • University of California, Irvine Medical Center
    Orange California 92868 United States
  • University of California, Davis
    Sacramento California 95817 United States
  • University of California, San Francisco
    San Francisco California 94158 United States
  • City of Hope
    Duarte California 91010 United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
PACT Pharma, Inc.
ID
NCT03970382
Phase
Phase 1 Solid Tumor Research Study
Study Type
Interventional
Participants
About 21 people participating
Last Updated