A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability, timing of administration 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 participants with B-cell malignancies post 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 and timing of administration will be evaluated in Phase I in order to define a recommended dosing level and time of administration for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.

NCT Number	NCT06045910
Lead Sponsor	Cancer Research UK Collaborators: Aleta BioTherapeutics
Conditions	Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Large B-cell Lymphoma
Enrollment	84 participants
Start Date	2024-02-07
Primary Completion	2028-02 (estimated)
Study Completion	2029-12-21 (estimated)
Updated on ClinicalTrials.gov	2025-07-28