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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525234-39 | EudraCT Number | ||
| 2026-525234-39-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-95804306 | Drug | JNJ-95804306 will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) | 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. | Up to 21 days after first full dose of study drug |
| Number of Participants with Adverse Events (AEs) by Severity | 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. | Up to 6 years 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) | 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. |
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Inclusion criteria:
For Arm A:
For Arm B:
Exclusion criteria:
For Arm A:
For Arm B:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Blood & Marrow Transplantation | Recruiting | Indianapolis | Indiana | 46237 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| AML SoC | Drug | AML SoC will be administered subcutaneously/intravenously. |
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| CLL/SLL SoC | Drug | CLL/SLL SoC will be administered orally/ intravenously. |
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| Up to first 28 days after first dose of study drug |
| Serum Concentrations of JNJ-95804306 | Serum samples will be analyzed to determine concentrations of JNJ-95804306. | Up to approximately 6 years 5 months |
| Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306 | AUC[t] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state. | Up to approximately 6 years 5 months |
| Maximum Plasma Concentration (Cmax) of JNJ-95804306 | Cmax is defined as the maximum serum concentration of JNJ-95804306. | Up to approximately 6 years 5 months |
| Minimum Plasma Concentration (Cmin) of JNJ-95804306 | Cmin is defined as the minimum plasma concentration of JNJ-95804306. | Up to approximately 6 years 5 months |
| Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML) | 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. | Up to 6 years 5 months |
| Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS) | 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. | Up to 6 years 5 months |
| Complete Response (CR) in Participants with MDS | CR is achieved when a participant with MDS has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria. | Up to 6 years 5 months |
| Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL) | OR is achieved when a participant with CLL has a CR or PR according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. | Up to 6 years 5 months |
| Complete Response in Participants with CLL | Complete response as per iwCLL response criteria will be reported. | Up to 6 years 5 months |
| Overall Response in Participants with Small Lymphocytic Lymphoma (SLL) | 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. | Up to 6 years 5 months |
| Complete Response in Participants with SLL | Complete response is achieved when a participant with SLL has a best response of CR according to the revised response criteria for malignant lymphoma. | Up to 6 years 5 months |
| Duration of Response (DoR) | 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. | Up to 6 years 5 months |
| Time to Response (TTR) | TTR is defined for responders only, as the time from the first dose of any study treatment to first qualifying response. | Up to 6 years 5 months |
| Start Midwest |
| Recruiting |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | Piscataway | New Jersey | 08854 | United States |