Health Trials

About this trial

This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or non-small cell lung cancer (NSCLC) will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.

Eligibility criteria

Qualifiers

Patients ≥ 18 years of age

Histologically confirmed metastatic pancreatic adenocarcinoma or cholangiocarcinoma

Histologically confirmed metastatic colorectal cancer

Histologically confirmed metastatic non-small cell lung cancer

Disqualifiers

1. Active hepatitis B or hepatitis C infection 2. Patients with a severe acquired or inherited immunodeficiency, including HIV positive patients with a CD4 count ≤ 350 cells/μL. In order to qualify, HIV positive patients must also be on an established antiretroviral therapy regimen with a viral load of <400 copies/mL.

Trial design

Treatments tested in this trial

  • TCR1188-ABC cells
  • Fludarabine + Cyclophosphamide combination
  • Tocilizumab

Treatment groups

30 Participants
are divided into 4 treatment groups

Locations

1
University of Pennsylvania19104, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

University of Pennsylvania

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov