BY002 IIT Study in R/R Acute Leukemia

This is a single-center, open-label, investigator-initiated phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of the menin inhibitor BY002 in patients with relapsed or refractory acute leukemia. Eligible subjects include adult patients (≥18 years) with AML, ALL, or MPAL, excluding APL, who carry KMT2A rearrangement or NPM1 mutation and have no better treatment options. The study will be conducted in a dose-escalation design (3+3) , followed by expansion at the recommended dose. BY002 is administered orally in 28-day cycles until disease progression

Trial Details

NCT ID

NCT07270770

Phase

PHASE1

Sponsor

The First Affiliated Hospital of Soochow University

Status

RECRUITING

Cancer Type

Leukemia

Interventions

BY002

Locations (sample)

Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

Age ≥16 years.
Confirmed diagnosis of AML, ALL, or MPAL per WHO 2022 criteria.
Relapsed or refractory disease after ≥1 prior therapy.
Presence of KMT2A rearrangement or NPM1 mutation (preferred, but not exclusive).

For full eligibility, visit ClinicalTrials.gov.

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