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).

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

Hematologic Neoplasms

Hematologic Malignancies

Blood Cancer

Hematological Malignancies

JNJ-95804306

AML SoC

CLL/SLL SoC

A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

Serum samples will be analyzed to determine concentrations of JNJ-95804306.

AUC[t] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state.

Cmax is defined as the maximum serum concentration of JNJ-95804306.

Cmin is defined as the minimum plasma concentration of JNJ-95804306.

Complete response (CR) is achieved when a participant with AML has a best response of CR (complete response with partial hematologic recovery [CRh] or complete response with incomplete hematologic recovery [CRi]) according to the European Leukemia Network (ELN) 2022 criteria.

OR is achieved when a participant with MDS has a CR (any type, that is CRh or complete response with limited count recovery [CRL]), partial response (PR), or hematologic improvement (HI) according to the International Working Group (IWG) 2023 criteria.

CR is achieved when a participant with MDS has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria.

OR is achieved when a participant with CLL has a CR or PR according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.

Complete response as per iwCLL response criteria will be reported.

Overall response is achieved when a participant with NHL subtypes including SLL has a CR or PR according to the revised response criteria for malignant lymphoma.

Complete response is achieved when a participant with NHL subtypes including SLL has a best response of CR according to the revised response criteria for malignant lymphoma.

Overall response is achieved when a participant with WM has a CR or PR according to international workshop on waldenstrom's macroglobulinemia 2013

Complete response is achieved when a participant with WM has a best response of CR according to international workshop on waldenstrom's macroglobulinemia 2013.

Participants with BOR based on indication-specific criteria will be reported.

DOR is defined for responders only, as time from date of initial documentation of a response to the first documented evidence of no response, disease progression, relapse, initiation of a new systemic anti-cancer therapy (besides hematopoietic stem cell transplant [HSCT]), or death, whichever comes first.

TTR is defined for responders only, as the time from the first dose of any study treatment to first qualifying response.

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.

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.

A DLT is defined as any toxicity that requires discontinuation of treatment; any Grade 5 toxicity; Non-hematologic Toxicity (Grade 3 or 4); and unacceptable hematologic toxicity.

Overall response in participants with SLL is achieved when a participant with SLL has a CR or PR according to the revised response criteria for malignant lymphoma.

Complete response is achieved when a participant with SLL has a best response of CR according to the revised response criteria for malignant lymphoma.

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.

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

Trials at a glance

Trials at a glance