NCT06045910

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

A Cancer Research UK Phase I/II Trial of ALETA-001 in Participants Who Have Received an Anti-CD19 CAR T-Cell Therapy for the Treatment of B-cell Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphoma, Non-Hodgkin
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Lymphoma, Follicular
• Lymphoma, B-Cell
• Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	ALETA-001	ALETA-001 will be administered intravenously (IV) every two weeks.

Timeline

• Start date: 2024-02-07
• Primary completion: 2028-02-01
• Completion: 2029-12-21
• First posted: 2023-09-21
• Last updated: 2025-07-28

Locations

7 sites across 1 country: United Kingdom