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NCT07572006

A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Enrollment reduced 11%.

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 360 → 320 participants
    • Trial sites expanded: 16 → 19 locations
  2. Study sites: 15 to 16
    • Interventions: AML SoC (Drug), CLL/SLL SoC (Drug), JNJ-95804306 (Drug) to AML SoC (Drug), CLL/SLL SoC (Drug), JNJ-95804306 (Drug)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 8 of 17 entries
  3. Trial sites expanded: 8 → 15 locationsv5
  4. Enrollment increased: 280 → 360 participants
    • Trial sites expanded: 3 → 8 locations
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 14 to 17
    v4
  5. Recruitment opened
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of May 15, 2026 to May 13, 2026
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days after first full dose of study drug
Number of Participants with Adverse Events (AEs) by Severity
Timeframe: Up to 6 years 5 months

Secondary (17)

For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Serum Concentrations of JNJ-95804306
Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306
Maximum Plasma Concentration (Cmax) of JNJ-95804306
Minimum Plasma Concentration (Cmin) of JNJ-95804306
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Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML)
Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS)
Complete Response (CR) in Participants with MDS
Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL)
Complete Response in Participants with CLL
Overall Response in Participants with Non-Hodgkin Lymphoma (NHL) Subtypes Including Small Lymphocytic Lymphoma (SLL)
Complete Response in Participants With NHL Subtypes Including SLL
Overall Response in WM (Waldenstrom's Macroglobulinemia)
Complete Response in WM
Best Overall Response (BOR) Based on Indication-Specific Criteria
Duration of Response (DoR)
Time to Response (TTR)

Arms and interventions

Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)Experimental

Participants with relapsed/refractory (R/R) AML/HR-MDS will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to standard of care (SoC) therapy in AML (Arm A2) to determine the putative recommended phase 2 dose (RP2D) in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to SoC therapy in AML (Arm A2) at the determined RP2D regimen(s). For US sites: Participants with R/R AML/HR-MDS will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). AML SoC will not be administered for US sites.

Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapyExperimental

Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) at the determined RP2D regimen(s). For US sites: Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). CLL/SLL/NHL SoC will not be administered for US sites.

Drugs: JNJ-95804306, AML SoC, CLL/SLL SoC

Sites

19 sites in 7 countries

United States 6, France 4, Australia 2, Belgium 2, Denmark 2, Spain 2, United Kingdom 1