Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06424340

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

Led by Miltenyi Biomedicine GmbH · Updated on 2026-04-16

29

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ability to understand and provide signed informed consent
  • Relapsed or refractory acute myeloid leukemia without standard treatment options, defined as no complete remission or residual disease after at least two courses of standard therapy, or relapse after first-line treatment, or relapse/non-response after allogeneic stem cell transplant without eligibility for further transplantation or donor lymphocyte infusion
  • Positive for HLA-A*02:01 by genotyping
  • Presence of NPM1 mutation recognized by the therapy and measurable by specific Q-PCR
  • Circulating white blood cell count above 1x10^9/L with less than 50% leukemic blasts and at least 0.03 x 10^9 CD8+ T cells/L
  • Life expectancy of at least 3 months
  • ECOG performance status between 0 and 3
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective contraception during the trial for fertile men and women
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2, or Treponema Pallidum
  • Clinically significant, advanced or unstable disease or inadequate organ function increasing risk for severe complications
  • Use of systemic immunosuppressive drugs such as cyclosporine or corticosteroids above specified doses; inhaled steroids and adrenal insufficiency replacement allowed
  • Unwillingness or inability to comply with trial procedures
  • Uncontrolled life-threatening infections or disseminated intravascular coagulation unless resolved before treatment
  • Current or recent use (within 30 days) of other investigational medicinal products
  • High-dose immunosuppression for immune disorders interfering with T cell function
  • Known allergy to any drugs used in mandatory trial procedures
  • Serum creatinine ≥ 2.0 x upper limit of normal or estimated glomerular filtration rate below 30 mL/min
  • Body mass index 40 or higher
  • Vaccination with live vaccines within 6 weeks before treatment
  • Major surgery within 30 days before treatment
  • Institutionalization by judicial or official order

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, Netherlands, 2333

Actively Recruiting

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Research Team

J

Jörg Liebmann

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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