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A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
155
Participants Needed
9
Research Sites
67 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating JNJ-90189892 for people with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic neoplasms (MDS), which are types of blood and bone marrow cancers that do not respond to treatment or come back after treatment. The study aims to find the safe and effective dose(s) of JNJ-90189892 alone and in combination with azacitadine (AZA) and venetoclax (VEN) in different groups of participants, including those newly diagnosed with AML. The research is conducted in multiple parts to carefully assess safety, tolerability, and treatment effects. Participants in Part 1 will receive escalating doses of JNJ-90189892 to determine the recommended phase 2 dose (RP2D). In Part 2, participants receive JNJ-90189892 at the RP2D to further evaluate safety and efficacy. Part 3 involves participants with relapsed or refractory AML receiving JNJ-90189892 combined with AZA and VEN to find the recommended phase 2 combination dose (RP2CD). Part 4 includes newly diagnosed AML participants receiving the combination starting at the dose found safe in Part 3. Dosing decisions are guided by a study evaluation team. During the study, participants will be monitored for adverse events, dose-limiting toxicities, and treatment responses for up to about 2.5 years. Researchers will assess blood levels of JNJ-90189892, immune response, complete and overall response rates, duration and time to response, transfusion independence, and survival outcomes in certain groups. Safety evaluations include ongoing assessments from screening through 30 days after the last dose. Participants will have regular visits and laboratory tests to track their health and response to treatment throughout the study.
CONDITIONS
Brief Title
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia (AML) or moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per WHO 2022 criteria and IPSS-M risk scoring (Parts 1, 2, and 3)
- Previously untreated acute myeloid leukemia (AML) diagnosis for Part 4 only
- Body weight greater than or equal to 40 kg
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate kidney function with estimated glomerular filtration rate (eGFR) of at least 40 mL/min
- Laboratory test results within required ranges
You will not qualify if you...
- History of significant lung problems, especially if supplemental oxygen is currently needed
- Uncontrolled systemic infections including viral, bacterial, or fungal infections
- Known allergies or intolerance to JNJ-90189892 or its ingredients
- For Parts 3 and 4: Known allergies or intolerance to venetoclax (VEN) or azacitadine (AZA)
- Major surgery or serious injury within 14 days before first dose
- Prior or current second cancer that may affect safety or study results
- Active involvement of central nervous system by disease
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2.5 years or until disease progression or discontinuation
Participants receive the study drug JNJ-90189892 alone or in combination with Azacitadine and Venetoclax. Dose escalation occurs in Part 1 to determine the recommended dose, followed by dose expansion and combination treatment in subsequent parts.
Visits occur regularly during dosing and combination therapy as per study protocol
Duration - Approximately 30 days after last dose
Participants are monitored for safety and treatment outcomes for up to 30 days after the last dose of study drug, including adverse events and response evaluations.
1 to 2 follow-up visits (in-person)
Trial Site Locations
Total: 9 locations
1
Concord Hospital
Concord, Australia, 2139
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2
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
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3
Sir Charles Gairdner Hospital
Nedlands, Australia, 6009
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4
Institut Paoli-Calmettes
Marseille, France, 13273
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5
CHRU de Strasbourg - Hopital de Hautepierre
Strasbourg, France, 67200
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6
Institut Claudius Regaud
Toulouse, France, 31100
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7
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
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8
Clinica Univ. de Navarra
Pamplona, Spain, 31008
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9
Hospital Universitario Virgen Rocio
Seville, Spain, 41013
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Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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