NCT07722312 BN-104 Refractory acute myeloid leukemia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07722312 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07722312 is a hot trial to watch
Refractory acute myeloid leukemia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07722312 is notable because it evaluates BN-104 in a Phase 1/2 design sponsored by Les Laboratoires Servier SAS. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07722312 |
| Official title | S243249 Monotherapy in Patients With Relapsed or Refractory Acute Leukemia With a KMT2A or NUP98 Translocation or Relapsed or Refractory AML With NPM1c Mutation |
| Phase / status | Phase 1/2 / Not yet recruiting |
| Intervention | BN-104 |
| Sponsor | Les Laboratoires Servier SAS |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Incidence of Adverse Events (AEs) |
| Endpoint time frame | Through Safety Follow-up (Approximately 3 years) |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The objective of this study is to establish the efficacy, safety, and tolerability of S243249 and to establish the recommended phase 2 dose (RP2D) of S243249 monotherapy in participants with relapsed/refractory (R/R) acute leukemia with select mutations. Phase 1 dose optimization will determine the RP2D to be used in Phase 2 dose expansion. The study will include a screening period, a treatment period consisting of continuous 28-day cycles of treatment, a safety follow-up period and a long-term follow-up period. Participants may undergo blood tests, electrocardiogram (ECG), bone marrow aspirations, vital sign checks, questionnaires, and physical exams.
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Incidence of Adverse Events (AEs) (Through Safety Follow-up (Approximately 3 years))
- Severity of AEs (Through Safety Follow-up (Approximately 3 years))
- Number of changes in laboratory values (Through Safety Follow-up (Approximately 3 years))
- Number of changes in electrocardiogram (ECG) (Through Safety Follow-up (Approximately 3 years))
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: BN-104 is indexed as Small molecule drug, with target menin, mechanism menin inhibitors, and global highest development status Phase 2.
Company & Deal Intelligence MCP profile: Les Laboratoires Servier SAS is resolved to a normalized organization record in France. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07722312 provides a focused lens on Refractory acute myeloid leukemia development. Its value will be determined by whether BN-104 can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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