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

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Trial Identification

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

Official Title: A Cancer Research Phase I/ II Trial of ALETA-001 in Participants Who Do Not Achieve or Maintain an Optimal Response to Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Malignancies

Study ID: NCT06045910

Conditions

Lymphoma, Non-Hodgkin

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell

Interventions

ALETA-001

Study Description

Brief 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.

Detailed Description: