Phase 1 Study of JNJ-95804306 in Relapsed or Refractory AML, CLL, Higher‑Risk MDS, and SLL

The trial enrolled 105 participants diagnosed with relapsed or refractory hematologic malignancies, including acute myeloid leukemia, chronic lymphocytic leukemia, higher‑risk myelodysplastic syndromes, and small lymphocytic lymphoma. Both male and female patients were eligible, and enrollment spanned the full age spectrum represented by the study’s age‑range codes, encompassing pediatric (code 4) and adult (code 3) cohorts. All subjects were required to have a confirmed diagnosis of one of the specified relapsed or refractory conditions and to be in generally adequate health to receive investigational therapy. Lifestyle factors such as diet, physical activity, and smoking status were not specified in the sponsor’s description. Selection was based on disease status and demographic eligibility; no additional inclusion or exclusion criteria were detailed.

The study is a Phase 1 investigation of JNJ‑95804306 in adults with relapsed or refractory hematological malignancies, including acute myeloid leukemia, chronic lymphocytic leukemia, higher‑risk myelodysplastic syndromes, and small lymphocytic lymphoma. Enrollment began on 30 June 2026 and the trial is planned to conclude on 24 September 2032. After obtaining informed consent, participants undergo a screening visit to confirm eligibility, followed by a baseline assessment on Day 1 of treatment. Subsequent study visits are scheduled at regular intervals to monitor safety, pharmacokinetics, and preliminary efficacy, with the frequency defined by the protocol. The trial concludes with an end‑of‑study visit after the final dosing period, at which point all study assessments are completed. Participants remain in the study for the duration of the treatment and follow‑up schedule unless discontinuation criteria are met, such as disease progression, unacceptable toxicity, withdrawal of consent, or other protocol‑specified reasons that may lead to early termination of individual involvement.

The study protocol does not provide details regarding the experimental medication, including its name, pharmaceutical form, dosage, route of administration, or frequency, nor does it specify any non‑experimental treatments such as standard‑of‑care therapy, placebo, or comparator agents, and no additional information on dosing schedules or compliance monitoring is described.

Efficacy will be evaluated in accordance with the study protocol.