What this study is
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).
What's being tested
- JNJ-95804306
Intervention · DRUG
JNJ-95804306 will be administered orally.
- AML SoC
Intervention · DRUG
AML SoC will be administered subcutaneously/intravenously.
- CLL/SLL SoC
Intervention · DRUG
CLL/SLL SoC will be administered orally/ intravenously.
Study details
- Official title
- A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
- Sponsor
- Janssen Research & Development, LLC
- Conditions
- Hematologic Neoplasms
- Enrolling
- 320 people
- Starts
- 2026-05-13
- Est. completion
- 2032-09-24
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedArm A
You may qualify if
- 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
You can't join if
- 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
Arm B
You may qualify if
- 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: a. 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (19)
19 openIndiana Blood & Marrow Transplantation
Indianapolis, Indiana, United States
RecruitingStart Midwest
Grand Rapids, Michigan, United States
RecruitingRutgers Cancer Institute of New Jersey
Piscataway, New Jersey, United States
RecruitingNYU Langone Health
New York, New York, United States
RecruitingSarah Cannon Cancer Institute
Nashville, Tennessee, United States
RecruitingMD Anderson Cancer Center - University of Texas
Houston, Texas, United States
Recruiting
13 sites outside the US
Concord Hospital
Concord, Australia
RecruitingPeter MacCallum Cancer Centre
Melbourne, Australia
RecruitingUZ Antwerpen
Edegem, Belgium
RecruitingGhent University Hospital
Ghent, Belgium
RecruitingAarhus University Hospital
Aarhus N, Denmark
RecruitingRigshospitalet
Copenhagen, Denmark
RecruitingInstitut Paoli Calmettes
Marseille, France
RecruitingCHU Lyon Sud
Pierre-Bénite, France
RecruitingInstitut Claudius Regaud
Toulouse, France
RecruitingCHRU Tours Hopital Bretonneau
Tours, France
RecruitingHosp Univ Fund Jimenez Diaz
Madrid, Spain
RecruitingClinica Univ. de Navarra
Pamplona, Spain
RecruitingThe Christie Nhs Foundation Trust
Manchester, United Kingdom
Recruiting
Study team
Sponsor
Janssen Research & Development, LLC
Study ID 95804306EDI1001
Study director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.