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RecruitingLast updated: 23 July 2026

Testing how safe a new drug called JNJ-95804306 is and finding the best dose to use for people whose blood cancer has come back or has not responded to treatmentA Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This study is testing a new investigational medicine called JNJ-95804306 in people with certain blood cancers that have come back after treatment (relapsed) or have not responded to treatment (refractory). The study is recruiting adults with conditions including:

  • Acute myeloid leukaemia (AML)
  • Myelodysplastic syndromes (MDS)
  • Chronic lymphocytic leukaemia (CLL)
  • Small lymphocytic lymphoma (SLL)

The study has two parts.

Part 1 (Dose Escalation)
Researchers will test different dose levels of JNJ-95804306 to find the safest and most suitable dose. Participants will be closely monitored for side effects and how well they tolerate the treatment.

Part 2 (Dose Expansion)
Once a suitable dose has been identified, more participants will receive JNJ-95804306 to further assess its safety and to see how well it works against these blood cancers.

At sites outside the United States, JNJ-95804306 may be given on its own or together with standard treatments for AML, MDS, CLL or SLL. At United States sites, JNJ-95804306 will be given on its own.

Researchers will also study how the body processes JNJ-95804306 and whether the treatment can help reduce or control cancer. The information collected will help determine whether JNJ-95804306 should be studied further in future clinical trials. 

 

Conditions

This trial is treating people with relapsed or refractory blood cancers, include acute myeloid leukaemia, high-risk myelodysplastic syndrome, chronic lymphocytic leukaemia, small lymphocytic lymphoma or non-Hodgkin lymphoma

Eligibility

Inclusion

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:

    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

Exclusion

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:

  • 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)

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07572006 *
  • 2026-525234-39-00 *
  • 95804306EDI1001; 95804306EDI1001; 2026-525234-39;

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

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

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