RecruitingPhase 1Phase 2NCT06045910

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

Sponsor

Cancer Research UK

Enrollment

84 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This Phase I/II study tests a new drug called ALETA-001 for patients with relapsed or refractory B-cell lymphomas who previously received CAR-T cell therapy. The drug is designed to help the immune system continue fighting the cancer after CAR-T therapy has stopped working. **You may be eligible if...** - You are 18 or older - You have a B-cell lymphoma that relapsed after CAR-T cell therapy - Your organ function (kidney, liver, heart) is within acceptable ranges - You are in good enough overall health to participate **You may NOT be eligible if...** - You have active serious infections or autoimmune conditions requiring treatment - You have untreated brain involvement by lymphoma - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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