TCR1188-ABC Cells in KRAS-mutated Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
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
Active hepatitis B or hepatitis C infection
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.
Any other active, uncontrolled infection.
Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 5).
Trial design
Treatments tested in this trial
- TCR1188-ABC cells
- Fludarabine + Cyclophosphamide combination
- Tocilizumab
Treatment groups
30 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov