OncoMatch/Clinical Trials/NCT06424340
MB-dNPM1-TCR.1 in Relapsed/Refractory AML
Is NCT06424340 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies MB-dNPM1-TCR.1 for leukemia, myeloid, acute.
Treatment: MB-dNPM1-TCR.1 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: NPM1 mutation recognized by dNPM1-TCR.1
AML has NPM1 mutation which is recognized by dNPM1-TCR.1 and for which a specific Q-PCR is available for disease monitoring.
Required: HLA-A A*02:01 (positive)
Positive for HLA-A*02:01 according to genotyping results.
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: intensive chemotherapy or decitabine or other standard therapy (intensive chemotherapy, decitabine)
No morphological CR after at least two courses of intensive chemotherapy, decitabine or other standard therapy
Lab requirements
Blood counts
Number of circulating WBC above 1x10^9/L with less than 20% leukemic blasts and at least 0.3x10^9 T cells/L and 0.03 x 10^9 CD8+ T cells/L.
Kidney function
Serum creatinine < 2.0 × ULN and eGFR ≥ 30 mL/min calculated according to the modified MDRD formula.
Number of circulating WBC above 1x10^9/L with less than 20% leukemic blasts and at least 0.3x10^9 T cells/L and 0.03 x 10^9 CD8+ T cells/L. Serum creatinine ≥ 2.0 × ULN or eGFR < 30 mL/min calculated according to the modified MDRD formula [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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