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NCT05453903Phase 1ACTIVE NOT RECRUITING

A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

Study Summary

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).

Conditions
Leukemia, Myeloid, Acute
Interventions / Drugs
BleximenibVenetoclax (VEN)Azacitidine (AZA)CytarabineDaunorubicin or Idarubicin
View on ClinicalTrials.gov ↗
Sponsor
JNJ
Johnson & Johnson
Diversified Pharma
C51/100
Study Details
Enrollment196 participants
Primary Completion—
Lead SponsorJanssen Research & Development, LLC
Data Retrieved2026-04-11 02:55:31.551002+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 196 participants
Sponsor Catalyst Profile

Johnson & Johnson (JNJ) is the sponsoring company for this trial. BiotechSign currently grades this company C (51/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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