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 Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by David Oh
Headshot of David Oh
David Oh

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

  • UCSF
    San Francisco California 94158 United States
  • University of California, Davis
    Sacramento California 95817 United States

Lead Scientist at UCSF

  • David Oh
    I am a physician-scientist focused on developing novel immunotherapies with enhanced activity and reduced toxicity, for patients with solid cancers. Clinically, I see patients in the Cancer Immunotherapy Program where I lead numerous early phase trials, with a particular focus on adoptive cell therapies for solid tumors (CAR-T and TCR).

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
PACT Pharma, Inc.
ID
NCT03970382
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 21 people participating
Last Updated
Contact us about this trial