BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia

ConditionAcute Myeloid Leukemia

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorChen Suning

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have been fully informed about the study and have voluntarily signed the ICF;

Patients with newly diagnosed primary AML according to the 2022 World Health Organization (WHO) criteria (Groups A and B) or patients with relapsed/refractory AML who have been previously treated with menin inhibitor monotherapy (Group C) and have an intermediate or poor prognosis according to the 2022 ELN Risk Stratification, as well as a defined combination of NPM1 mutation or NUP98 rearrangement or KMT2A rearrangement

Peripheral blood leukocyte count ≤ 25 x 109/L (limited to patients enrolled in groups B and C, where hydroxyurea is allowed to control peripheral blood leukocyte count)

Aged 18 years or older;

Disqualifiers

have active central nervous system (CNS) leukemia;

a known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis:Positive hepatitis B surface antigen (HBsAg) serology requires a negative hepatitis B virus (HBV) DNA test for enrollment; For patients with hepatitis C virus (HCV) antibody serology positive, a negative HCV RNA test result is required for enrollment.

known human immunodeficiency virus (HIV) infection;

pregnant (positive screening pregnancy test) or lactating females;

Trial design

Design model

Parallel

Treatments tested in this trial

BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine
Drug
The starting dose cohort(200mg BID N104) combined Intensive Chemotherapyor Venetoclax/Azacitidine. Each treatment cycle is anticipated to be 28 days in length, although cycle delays may be made due to delayed count recovery.

Treatment groups

135 Participants

are divided into 3 treatment groups

Group A: BN104 Combined Intensive Chemotherapy in patients with newly diagnosed AMLExperimental treatment 1 intervention

Group B: BN104 Combined Venetoclax/Azacitidine in patients with newly diagnosed AMLExperimental treatment 1 intervention

Group C: BN104 Combined Venetoclax/Azacitidine in patients with relapsed/refractory AMLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Evaluate the safety and tolerability of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy

Incidence of DLTs (evaluated at the end of cycle 1 for each dose level);

Time frame

At the end of Cycle1 (Cycle1 Day28)

Secondary outcomes

Peak concentration (Cmax)

Assess the Cmax of BN104 and its metabolite BNM-1263

Time frame

At the first Cycle, and Day1 of Cycle 2 (each cycle is 28days)

Auc(0-last）

Assess the area under the plasma concentration-time curve from time zero to the last quantifiable time point of BN104 and its metabolite BNM-1263

Time frame

At the first Cycle, and Day1 of Cycle 2 (each cycle is 28days)

To evaluate the CR rate of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy

Time frame

At the screening, Cycle1Day28, Cvcle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)

ORR (CR+CRh+CRi+PR+MLFS)

To evaluate the ORR rate of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy

Time frame

At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)

Other outcomes

MRD negativity rate

Assessment of CR with minimal residual disease (MRD) negativity and CRc with MRD negativity rate of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy in patients with relapsed/refractory AML harboring specific gene alterations.

Time frame

At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)

PD: MEIS1

Assessment of the effect of BN104 in combination with intensive chemotherapy or Venetoclax/Azacitidine on MEIS1

Time frame

At the screening and the end of Cycle 1 (each cycle is 28 days)

PD: HOXA9

Assessment of the effect of BN104 in combination with intensive chemotherapy or Venetoclax/Azacitidine on HOXA9

Time frame

At the screening and the end of Cycle 1 (each cycle is 28 days)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chen Suning

Lead sponsor

The First Affiliated Hospital of Soochow University

Sponsor institution

BioNova Pharmaceuticals (Shanghai) LTD.

Collaborator

Source ClinicalTrials.gov

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