RecruitingPhase 1Phase 2NCT06424340

MB-dNPM1-TCR.1 in Relapsed/Refractory AML

A Phase I/II Trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive Patients With Relapsed or Refractory NPM1-mutated AML to Determine Safety and Obtain First Data on Efficacy


Sponsor

Miltenyi Biomedicine GmbH

Enrollment

29 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this Phase I/II, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR) specific for dNPM1 peptides restricted to human leukocyte antigen (HLA) A\*02:01 in patients with relapsed or refractory AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental treatment called MB-dNPM1-TCR.1 — a type of cell therapy where specially engineered immune cells are infused to find and attack leukemia cells — in patients with relapsed or treatment-resistant acute myeloid leukemia (AML) who have limited other options. **You may be eligible if...** - You are 18 or older - You have AML that has come back or did not respond to at least two standard treatments - Your cancer carries a specific genetic change called NPM1 mutation - You have a specific immune marker called HLA-A*02:01 - You have a life expectancy of at least 3 months - Your blood counts and T cell levels meet specific thresholds **You may NOT be eligible if...** - You are pregnant - You have active, uncontrolled infection - You have another active cancer - Your organ function is severely impaired 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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Interventions

BIOLOGICALMB-dNPM1-TCR.1

T Cell Receptor (TCR) T cell therapy


Locations(1)

Leiden University Medical Center

Leiden, Netherlands

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NCT06424340


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