OncoMatch/Clinical Trials/NCT06746519
BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia
Official title: A Phase I/II , Multicenter, Open Label Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of the Combination of the Menin Inhibitor BN104 for the Treatment of Patients With Acute Myeloid Leukemia
Is NCT06746519 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine for acute myeloid leukemia.
Treatment: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine — The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: KMT2A (MLL) rearrangement
Required: NPM1 mutation
Required: NUP98 rearrangement
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: menin inhibitor — monotherapy
patients with relapsed/refractory AML who have been previously treated with menin inhibitor monotherapy (Group C)
Must have received: anti-leukemia therapy
previous failed treatment with menin inhibitors is required (Group C)
Cannot have received: anti-leukemia therapy
Exception: hydroxyurea or leukocyte monocloning for control of white blood cell count, all-trans retinoic acid for initial suspicion of acute promyelocytic leukemia, or nondemethylating medications for MDS
have received prior anti-leukemia therapy (for patients in Groups A and B), except for the following: use of hydroxyurea or leukocyte monocloning for control of white blood cell count, or treatment with all-trans retinoic acid due to initial suspicion of acute promyelocytic leukemia, or use of nondemethylating medications for the treatment of MDS
Cannot have received: menin inhibitor
pre-existing treatment with targeted menin (for Group A and B patients)
Cannot have received: chemotherapy, radiotherapy, hormonal therapy, targeted therapy, or immunotherapy
prior anti-leukemia therapy, including chemotherapy, radiotherapy, hormonal therapy, targeted therapy, or immunotherapy, administered less than 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study treatment (Group C)
Cannot have received: autologous hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation or CAR-T therapy within 60 days prior to the start of study treatment, or have not recovered from toxicity associated with ASCT or CAR-T therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
allogeneic HSCT within 100 days prior to the start of study treatment, or if the patient still has a combination of active acute and chronic graft-versus-host disease, or if the patient still requires immunosuppressive therapy
Lab requirements
Kidney function
creatinine clearance ≥ 45 ml/min (if <45 ml/min, allowed if creatinine ≤ 130 µmol/L); for Group B <75 years, creatinine clearance ≥ 30 ml/min allowed
Liver function
ALT and AST ≤ 2.5 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease); in Phase II, ALT/AST ≤ 5 x ULN if due to leukemia invasion; for Group B <75 years, total bilirubin ≤ 3 x ULN allowed
Cardiac function
left ventricular ejection fraction ≥ 45%; for Group B <75 years, LVEF < 50% allowed
adequate hepatic, renal, and cardiac function, as defined:Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal range (ULN);Total bilirubin ≤ 1.5 x ULN* and in patients with Gilbert disease, total bilirubin ≤ 3 x ULN;Creatinine clearance ≥ 45 ml/min* as estimated by the Cockcroft-Gault formula (if <45 ml/min, enrollment is allowed if creatinine ≤ 130 µmol/L); Left ventricular ejection fraction ≥ 45%*; Note: In Phase II studies, ALT or AST may be relaxed to ≤5 x ULN if the investigator assesses that the elevated ALT or AST is due to leukemia invasion of the liver;For patients <75 years of age enrolled in Group B, total bilirubin ≤ 3 × ULN, creatinine clearance ≥ 30 ml/min, or left ventricular ejection fraction < 50% are allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06746519 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-leukemia therapy, menin inhibitor, chemotherapy, radiotherapy, hormonal therapy, targeted therapy, or immunotherapy disqualifies patients from enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 rearrangement is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify