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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07572006
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematologic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-95804306 — DRUG
    JNJ-95804306 will be administered orally.
  • AML SoC — DRUG
    AML SoC will be administered subcutaneously/intravenously.
  • CLL/SLL SoC — DRUG
    CLL/SLL SoC will be administered orally/ intravenously.

Study Details

The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).

Key Dates

Start date
May 13, 2026
Status verified
Jun 2026
Primary completion
May 18, 2029
Completion
Sep 24, 2032

Study Design

Enrollment
280 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)
    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.
  • Experimental: Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
    Participants with R/R CLL/SLL will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in 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 CLL/SLL (Arm B2 or B3) at the determined RP2D regimen(s). For US sites: Participants with R/R CLL/SLL 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 SoC will not be administered for US sites.

Primary Outcome Measure

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days after first full dose of study drug ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana Blood & Marrow TransplantationIndianapolisIndiana46237-
Start MidwestGrand RapidsMichigan49546-
Rutgers Cancer Institute of New JerseyPiscatawayNew Jersey08854-

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By research site
Indiana Blood & Marrow Transplantation· Indianapolis, INStart Midwest· Grand Rapids, MIRutgers Cancer Institute of New Jersey· Piscataway, NJ

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