Hematologic NeoplasmsPhase 1NCT07572006
A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
A Phase 1 study testing JNJ-95804306, AML SoC and CLL/SLL SoC in people with Hematologic Neoplasms, run by Janssen Research & Development, LLC at 19 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- JNJ-95804306, AML SoC and CLL/SLL SoC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 13 May 2026to 24 Sep 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Arm A:
- Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options
- Body weight greater than or equal to (>=) 40 kilograms (kg)
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- For Arm B:
- All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgement. Have a diagnosis of either: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) meeting 2018 International workshop on chronic lymphocytic leukemia (iwCLL) National cancer institute (NCI) working group guidelines (Hallek 2018) that meet the following criteria:
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- Participants must have received at least 2 prior lines of therapy; b. Have clinically measurable disease
- Body weight >= 40 kg
- ECOG performance status of 0 to 2
- Must sign an Informed consent form (ICF)
- For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgement. a. Participants must have received at least 2 prior lines of therapy
Who cannot join
- For Arm A:
- Has acute promyelocytic leukemia according to world health organization (WHO) 2022 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision
- Need for supplemental oxygen use to maintain adequate oxygenation
- Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
- For US sites: Has acute promyelocytic leukemia according to WHO 2022 criteria or known active CNS involvement of AML/MDS
- For Arm B:
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- Need for supplemental oxygen use to maintain adequate oxygenation
- Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention
- Developed Richter's transformation or prolymphocytic leukemia
- Known active CNS or leptomeningeal involvement of CLL/SLL/Non-Hodgkin lymphoma (NHL)
Trial locations and contacts
19 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 7 countries
United States6 sites, 6 recruiting
- Recruiting
Start Midwest
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson Cancer Center - University of Texas
Houston, Texas, 77030
- Recruiting
Indiana Blood & Marrow Transplantation
Indianapolis, Indiana, 46237
- Recruiting
Sarah Cannon Cancer Institute
Nashville, Tennessee, 37203
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey, 08854
France4 sites, 4 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
- Recruiting
CHU Lyon Sud
Pierre-Bénite, 69495
- Recruiting
Institut Claudius Regaud
Toulouse, 31059
- Recruiting
CHRU Tours Hopital Bretonneau
Tours, 37000
Australia2 sites, 2 recruiting
- Recruiting
Concord Hospital
Concord, 2137
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
Belgium2 sites, 2 recruiting
- Recruiting
UZ Antwerpen
Edegem, 2650
- Recruiting
Ghent University Hospital
Ghent, 9000
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, DK-8200
- Recruiting
Rigshospitalet
Copenhagen, DK-2100
Spain2 sites, 2 recruiting
- Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
- Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie Nhs Foundation Trust
Manchester, M20 4BX
About this study
Official title: A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
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).
- Conditions
- Hematologic Neoplasms
- Being tested
- JNJ-95804306, AML SoC, CLL/SLL SoC
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-95804306Drug
JNJ-95804306 will be administered orally.
AML SoCDrug
AML SoC will be administered subcutaneously/intravenously.
CLL/SLL SoCDrug
CLL/SLL SoC will be administered orally/ intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JNJ-95804306; Drug: AML SoC |
| Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy | Experimental | 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. Receives: Drug: JNJ-95804306; Drug: CLL/SLL SoC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 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.
Measured: Up to 6 years 5 months
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 years 5 months
Complete Response in Participants with CLL
Complete response as per iwCLL response criteria will be reported.
Measured: Up to 6 years 5 months
Overall Response in Participants with Non-Hodgkin Lymphoma (NHL) Subtypes Including Small Lymphocytic Lymphoma (SLL)
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.
Measured: Up to 6 years 5 months
Complete Response in Participants With NHL Subtypes Including SLL
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.
Measured: Up to 6 years 5 months
Overall Response in WM (Waldenstrom's Macroglobulinemia)
Overall response is achieved when a participant with WM has a CR or PR according to international workshop on waldenstrom's macroglobulinemia 2013
Measured: Up to 6 years 5 months
Complete Response in WM
Complete response is achieved when a participant with WM has a best response of CR according to international workshop on waldenstrom's macroglobulinemia 2013.
Measured: Up to 6 years 5 months
Best Overall Response (BOR) Based on Indication-Specific Criteria
Participants with BOR based on indication-specific criteria will be reported.
Measured: 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.
Measured: 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.
Measured: Up to 6 years 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start13 May 2026
- Primary completion18 May 2029 (estimated)
- Study completion24 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572006
- Sponsor's protocol ID
- 95804306EDI1001
- Other IDs
- 95804306EDI1001, 2026-525234-39, 2026-525234-39-00
- Status last verified
- Nov 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07572006
- Acronym / sponsor ID
- 95804306EDI1001
- Conditions
- Hematologic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 18 May 2029 (estimated)
- Study completion
- 24 Sep 2032 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS) | Experimental | Drug: JNJ-95804306, Drug: AML SoCParticipants 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 monotherapy | Experimental | Drug: JNJ-95804306, Drug: CLL/SLL SoCParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options
- Body weight greater than or equal to (>=) 40 kilograms (kg)
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgement. Have a diagnosis of either: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) meeting 2018 International workshop on chronic lymphocytic leukemia (iwCLL) National cancer institute (NCI) working group guidelines (Hallek 2018) that meet the following criteria:
- Body weight >= 40 kg
Key exclusion criteria (10 listed)
- Has acute promyelocytic leukemia according to world health organization (WHO) 2022 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision
- Need for supplemental oxygen use to maintain adequate oxygenation
- Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
- For US sites: Has acute promyelocytic leukemia according to WHO 2022 criteria or known active CNS involvement of AML/MDS
- Need for supplemental oxygen use to maintain adequate oxygenation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-95804306JNJ-95804306 will be administered orally. | Drug | Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS), Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy |
| AML SoCAML SoC will be administered subcutaneously/intravenously. | Drug | Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS) |
| CLL/SLL SoCCLL/SLL SoC will be administered orally/ intravenously. | Drug | Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy |
Primary outcome
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days after first full dose of study drug
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.
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 6 years 5 months
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.
17 secondary outcomes
For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to first 28 days after first dose of study drug
Serum Concentrations of JNJ-95804306
Time frame: 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
Time frame: Up to approximately 6 years 5 months
Maximum Plasma Concentration (Cmax) of JNJ-95804306
Time frame: Up to approximately 6 years 5 months
Minimum Plasma Concentration (Cmin) of JNJ-95804306
Time frame: Up to approximately 6 years 5 months
Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML)
Time frame: Up to 6 years 5 months
Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS)
Time frame: Up to 6 years 5 months
Complete Response (CR) in Participants with MDS
Time frame: Up to 6 years 5 months
Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL)
Time frame: Up to 6 years 5 months
Complete Response in Participants with CLL
Time frame: Up to 6 years 5 months
Overall Response in Participants with Non-Hodgkin Lymphoma (NHL) Subtypes Including Small Lymphocytic Lymphoma (SLL)
Time frame: Up to 6 years 5 months
Complete Response in Participants With NHL Subtypes Including SLL
Time frame: Up to 6 years 5 months
Overall Response in WM (Waldenstrom's Macroglobulinemia)
Time frame: Up to 6 years 5 months
Complete Response in WM
Time frame: Up to 6 years 5 months
Best Overall Response (BOR) Based on Indication-Specific Criteria
Time frame: Up to 6 years 5 months
Duration of Response (DoR)
Time frame: Up to 6 years 5 months
Time to Response (TTR)
Time frame: Up to 6 years 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-95804306, AML SoC and CLL/SLL SoC in people with Hematologic Neoplasms, run by Janssen Research & Development, LLC at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, France, Australia, Belgium, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days after first full dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.