Last reviewed · How we verify
NCT07270770
BY002 IIT Study in R/R Acute Leukemia
Phase 1 trial testing BY002 in Acute Leukemia in 18 participants. Currently enrolling.
31 March 2027
Quick facts
| Lead sponsor | The First Affiliated Hospital of Soochow University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 15 March 2026 |
| Primary completion | 31 March 2027 |
| Estimated completion | 31 July 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- BY002 — full drug profile →
Conditions studied
- Acute Leukemia — all drugs for Acute Leukemia →
- KMT2A Rearrangements or NPM1 Mutations Acute Leukemia — all drugs for KMT2A Rearrangements or NPM1 Mutations Acute Leukemia →
Sponsor
The First Affiliated Hospital of Soochow University
Who can join
16 and older, any sex, with Acute Leukemia or KMT2A Rearrangements or NPM1 Mutations Acute Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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, unacceptable toxicity, HSCT, withdrawal, or death. The primary objectives are to determine the incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs), and to define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Secondary objectives include characterization of PK parameters, evaluation of safety (AEs, laboratory tests, vital signs, ECG), and assessment of efficacy endpoints such as complete remission (CR), composite remission (CRc), overall response rate (ORR), duration of response (DOR), event-free survival (EFS), relapse-free survival (RFS), overall survival (OS), and cumulative incidence of relapse (CIR). Exploratory objectives include analysis of pharmacodynamic biomarkers (e.g., HOXA9, MEIS1, CD11b) and correlation of baseline genetic mutations (e.g., NPM1, KMT2A, FLT3, TP53, NUP98) with clinical outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07270770
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Leukemia
Currently open trials in the same condition.
- NCT07356154 — A Study of Revumenib and Mezigdomide in People With Leukemia · Phase 1, PHASE2 · recruiting
- NCT07362095 — Luspatercept for the Treatment of Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT) · Phase 1, PHASE2 · recruiting
- NCT07101497 — Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia · Phase 2 · recruiting
- NCT06984536 — Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT · Phase 2 · recruiting
- NCT06947044 — Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding · NA · recruiting
Other The First Affiliated Hospital of Soochow University trials
Trials by the same sponsor.
- NCT07350863 — U69-CART-Cells For R/R T-ALL · Phase 1 · recruiting
- NCT06985498 — Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL · Phase 2 · not yet recruiting
- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
- NCT07511426 — U96-CAR-T-Cells For R/R B-ALL · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07270770 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University
- Last refreshed: 18 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07270770.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing