A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies
Status:
Recruiting
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety,
tolerability and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell
engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks
in patients with relapsed non-Hodgkin lymphoma (NHL) who have failed to optimally respond to
prior treatment with anti-CD19 CAR T-cell therapy. This first in human study is divided into
2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different
dose levels of ALETA-001 will be evaluated in Phase I in order to define a recommended dosing
level and schedule for Phase II. Phase II will further evaluate the safety, PK and
therapeutic activity of ALETA-001.