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New treatment option for Acute Leukemia
Official title BY002 IIT Study in R/R Acute Leukemia
ClinicalTrials.gov ID: NCT07270770
What this study is testing
What is BY002?
BY002 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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).
- ECOG performance status 0-2.
You likely can't join if
- Active central nervous system (CNS) leukemia. (Prior CNS involvement allowed if treated and controlled; CNS prophylaxis permitted.)
- History of significant liver disease, including viral hepatitis or cirrhosis:
- HBsAg positive must have negative HBV DNA.
- HCV antibody positive must have negative HCV RNA.
- Known HIV infection.
- Pregnant or breastfeeding women.
See the full 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).
- ECOG performance status 0-2.
- Adequate organ function:
- ANC ≥1.0 × 10⁹/L (unless cytopenia due to leukemia)
- Platelets ≥50 × 10⁹/L (unless due to leukemia)
- ALT/AST ≤2.5 × ULN, bilirubin ≤1.5 × ULN
- Creatinine clearance ≥50 mL/min
- Negative pregnancy test for women of childbearing potential.
- Willing to use effective contraception during study and 90 days after last dose.
- Signed informed consent.
- Active central nervous system (CNS) leukemia. (Prior CNS involvement allowed if treated and controlled; CNS prophylaxis permitted.)
- History of significant liver disease, including viral hepatitis or cirrhosis:
- HBsAg positive must have negative HBV DNA.
- HCV antibody positive must have negative HCV RNA.
- Known HIV infection.
- Pregnant or breastfeeding women.
- Significant cardiac disease:
- Congenital long QT syndrome or QTcF \>450 msec.
- Acute myocardial infarction, unstable angina, or coronary artery bypass within 6 months.
- Congestive heart failure ≥ NYHA class II.
- History of another malignancy within 5 years, except adequately treated basal cell carcinoma of the skin, in-situ breast cancer, or in-situ cervical cancer.
- Autologous HSCT or CAR-T therapy within 60 days, or unresolved toxicities from ASCT/CAR-T.
- Allogeneic HSCT within 100 days, or active GVHD, or requiring ongoing immunosuppressive therapy.
- Anti-leukemia therapy within 2 weeks before study entry (hydroxyurea permitted).
- Prior investigational drug use: \<2 weeks or \<5 half-lives for small molecules; \<4 weeks or \<5 half-lives for biologics (whichever is shorter).
- Unresolved toxicities \> grade 1 from prior anti-leukemia therapy (except alopecia).
- Uncontrolled active infection:
- Mild infections manageable with oral/topical treatment are allowed.
- Serious infections requiring hospitalization/IV antibiotics within 14 days excluded, unless resolved.
- Febrile neutropenia without infection evidence may be eligible if afebrile \>72 h without antipyretics.
- Active tuberculosis excluded.
- Conditions impairing oral intake or absorption (e.g., swallowing difficulty, short bowel syndrome, gastroparesis).
- Known severe allergy to Menin inhibitors or any component of BY002.
- Investigator judges poor compliance or inability to complete study.
- Any other serious disease, abnormality, or condition that may increase risk, interfere with study drug, confound results, or expected survival ≤6 months.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.