MB-dNPM1-TCR.1 in Relapsed/Refractory AML
ConditionLeukemia, Myeloid, Acute
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiltenyi Biomedicine GmbH
About this trial
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 criteria
Qualifiers
Age ≥ 18 years
Patients must be able to understand and be willing to give signed informed consent
No morphological CR or extramedullary AML after at least two courses of intensive chemotherapy, decitabine or other standard therapy or
MRD positive after at least two courses of intensive chemotherapy or other standard therapy and not eligible for allogeneic stem cell transplantation or
Disqualifiers
Pregnant or breast feeding women.
Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2 or Treponema Pallidum.
Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe complications of trial participation at the discretion of the investigator.
Unwillingness or inability to comply with procedures required in this clinical trial protocol.
Trial design
Treatments tested in this trial
- MB-dNPM1-TCR.1
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov