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Phase 1 Study of JNJ-95804306 in Adults with Relapsed or Refractory AML, Higher‑Risk MDS, CLL and SLL

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people whose blood cancers have returned or did not respond to previous treatment. These cancers include acute myeloid leukemia, small lymphocytic lymphoma, higher-risk myelodysplastic syndromes, and chronic lymphocytic leukemia. The investigational medicine being tested is an oral tablet called JNJ-95804306.

The purpose of the trial is to find a dose that can be given safely. In a Phase 1 design, participants start with a low amount of the drug and the dose is slowly increased (dose escalation) to see how the body reacts. The medicine may be given alone (monotherapy) or together with other standard treatments (combination therapy). Researchers watch for any signs of problems, focusing on safety and tolerability by recording any dose‑limiting toxicities (effects that stop the dose from being raised) and other adverse events. The study proceeds in two parts: first to learn about safety, then to confirm the chosen dose in a larger group.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit and First Dose

    You will attend a baseline visit where your medical condition will be confirmed and initial safety tests will be performed.

    During this visit you will receive the first supply of JNJ-95804306, which is provided as an oral tablet. The exact amount and schedule will be explained by the study team.

    The study is a Phase 1 trial, meaning it is the first time this drug is given to humans to evaluate safety.

  2. Step 2

    Taking the Study Medication

    You will take the JNJ-95804306 tablet by mouth exactly as instructed, usually at the same time each day.

    If the protocol calls for a combination with another medication, that additional drug will also be taken as directed.

    The dose may be adjusted during the trial; any change will be explained to you before it occurs.

  3. Step 3

    Regular Safety Monitoring Visits

    You will return to the clinic at scheduled intervals for safety assessments, which may include blood tests, physical examinations, and questionnaires.

    These visits are used to detect any adverse events (unwanted side effects) and to determine if the drug is being tolerated.

    The primary focus of these assessments is to identify dose‑limiting toxicities (DLTs), which are side effects that prevent further increase of the dose.

  4. Step 4

    Dose Escalation (Part 1)

    In the first part of the study, known as dose escalation, the amount of JNJ-95804306 may be increased stepwise for groups of patients.

    Each increase will only occur after the safety team confirms that the previous dose was well tolerated.

    You will be informed of any dose change and will receive a new supply of tablets reflecting the new dose.

  5. Step 5

    Dose Expansion (Part 2)

    If a safe and potentially effective dose is identified, the study moves to the dose expansion phase.

    In this phase you will continue taking the same dose of JNJ-95804306 while additional patients are enrolled to gather more safety information.

    The same schedule of clinic visits and safety checks continues throughout this period.

  6. Step 6

    End‑of‑Study Assessments

    At the conclusion of your participation, you will undergo final assessments to document overall safety and any lasting effects of the drug.

    These assessments may include a final set of laboratory tests, a physical exam, and a summary of any adverse events experienced during the trial.

Who can join the trial?

7 criteria

  • You must be at least 18 years old or old enough to legally give consent in your country.
  • You must have a diagnosis of relapsed or refractory acute myeloid leukemia (AML) or higher‑risk myelodysplastic syndromes (MDS). “Relapsed” means the disease returned after treatment, and “refractory” means it did not respond to treatment. For these cancers you must have a bone‑marrow blast (immature cancer cells) level of 5% or higher, and the disease must be classified as moderate‑high, high, or very high risk according to standard scoring systems.
  • You must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no other approved medicines that would be better. You need to have received at least two prior lines of therapy (two separate courses of treatment) and have measurable disease, meaning either a high white‑blood‑cell count of lymphocytes (>5 × 10⁹/L) or enlarged lymph nodes or organs that can be felt by a doctor.
  • You must have a diagnosis of relapsed or refractory B‑cell non‑Hodgkin lymphoma (NHL) and meet specific rules for the type you have:
    • If you have diffuse large B‑cell lymphoma (DLBCL), you must have had at least two prior systemic treatments and either have received or be ineligible for high‑dose chemotherapy and an autologous stem‑cell transplant (a procedure that uses your own stem cells to restore blood‑forming cells).
    • If you have follicular lymphoma (FL), marginal zone lymphoma (MZL) (except the MALT subtype), or Waldenström macroglobulinemia (WM), you must have had at least two prior systemic treatments, and at least one of those must have included an anti‑CD20 antibody (a type of medicine that targets a protein on B‑cells).
    • If you have mantle cell lymphoma (MCL), you must have had at least one prior systemic treatment that included an anti‑CD20 antibody.
    • Your overall health must be good enough to have an ECOG performance status score of 0, 1, or 2. This scale rates how well you can carry out daily activities, where 0 means fully active and 2 means you are up and about more than 50% of waking hours but unable to work.

Who cannot join the trial?

22 criteria

  • Kidney function too low: an estimated glomerular filtration rate (eGFR) under 60 mL/min, which means the kidneys are not filtering waste well enough.
  • Very high white blood cell count for AML/MDS: more than 25 × 10⁹ per liter (about 25,000 cells per microliter), indicating uncontrolled disease.
  • Low hemoglobin for CLL: less than 8.0 g/dL, or if a blood transfusion or growth‑factor medication was needed in the past week.
  • Low neutrophil count for CLL: fewer than 1.0 × 10³ per microliter (about 1,000 cells per microliter), or very low count in the bone marrow, or a transfusion/growth‑factor needed in the past week.
  • Low platelet count for CLL: fewer than 25 × 10³ per microliter (about 25,000 cells per microliter), or a transfusion/growth‑factor needed in the past week, or active bleeding in the mouth/nose, or a spontaneous bleed within the last three months.
  • Liver enzymes too high: AST or ALT more than three times the normal upper limit (or more than four times if the disease already involves the liver).
  • High bilirubin: total bilirubin greater than 1.5 times the normal upper limit. (People with Gilbert’s syndrome may have a slightly different pattern.)
  • Low albumin for AML participants receiving combination therapy: less than 3.0 g/dL, indicating poor protein levels in the blood.
  • Uncontrolled infection: any ongoing viral, bacterial, or fungal infection that is not being adequately treated.
  • Recent major surgery or serious injury: surgery or a major injury within the two weeks before screening, not fully recovered, or planned surgery during the study period.
  • Recent serious heart problems (within six months): unstable chest pain (angina), heart attack, major clot events such as pulmonary embolism or stroke, dangerous heart rhythms, or severe heart failure classified as NYHA class III‑IV.
  • Active central nervous system (CNS) involvement: disease affecting the brain or spinal cord.
  • Recent chemotherapy for AML/MDS: any chemotherapy (except hydroxyurea or a single low dose of cytarabine) given within two weeks before the first study dose.
  • Recent radiation therapy for AML/MDS: radiation to any area within seven days before the first study dose.
  • Recent antibody treatment for AML/MDS: any antibody drug given within two weeks before the first study dose.
  • Recent targeted or investigational therapy for AML/MDS: any non‑BCL2 targeted drug or experimental agent given within two weeks or five drug half‑lives (whichever is shorter) before the first study dose.
  • Recent BCL2‑targeting drug for AML/MDS: any BCL2 inhibitor given within two weeks before the first study dose.
  • Recent chemotherapy or immunotherapy for CLL: given within two weeks before the first study dose.
  • Recent radiation therapy for CLL: given within seven days before the first study dose.
  • Recent monoclonal antibody (single‑target) for CLL: given within four weeks before the first study dose.
  • Recent BCL2‑targeting drug for CLL: given within two weeks before the first study dose.
  • Recent other targeted or investigational drugs for CLL: must have a drug‑free period of at least two weeks or five drug half‑lives (whichever is shorter) before the first study dose.
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Investigated drugs

JNJ-95804306 is an experimental oral tablet being studied for the first time in people whose blood cancers (such as acute myeloid leukemia, high‑risk myelodysplastic syndromes, chronic lymphocytic leukemia, small lymphocytic lymphoma, or non‑Hodgkin lymphoma) have returned or did not respond to previous treatments. In the trial the tablet may be given alone (monotherapy) or together with other standard cancer medicines (combination therapy) so researchers can learn how safe it is, how well patients tolerate it, and what dose might be most effective. The study will closely monitor side effects, how the drug works against the cancer, and will use this information to decide the best dose for future research.

What is already known about the treatment

JNJ-95804306 - This medication is taken by mouth as a tablet, so patients swallow it like a regular pill. It is an investigational small‑molecule drug that is currently in a Phase 1 first‑in‑human clinical trial, meaning it is still being studied and has not yet been approved for general medical use. The drug is being tested for cancers of the blood and bone marrow, specifically relapsed or refractory acute myeloid leukemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, and higher‑risk myelodysplastic syndromes. It works by blocking a specific protein that helps cancer cells grow and survive, classifying it as a targeted oral kinase inhibitor.

Investigated diseases

  • Relapsed or refractory acute myeloid leukemia

    A blood cancer in which immature myeloid cells build up in the bone marrow, crowding out normal blood cells. In the relapsed or refractory setting the disease returns after initial therapy or does not respond, causing a gradual increase in abnormal cells over time.

  • Relapsed or refractory small lymphocytic lymphoma

    A low‑grade B‑cell lymphoma that typically involves lymph nodes and the blood. When it is relapsed or refractory, the tumor reappears after treatment or continues to grow despite therapy, slowly expanding within lymphoid tissues.

  • Relapsed or refractory higher‑risk myelodysplastic syndromes

    A group of bone‑marrow disorders where blood cell production is ineffective and genetic abnormalities raise the risk of progression. In the relapsed or refractory state the condition persists or worsens after prior treatment, leading to worsening low blood counts and a higher chance of evolving to acute leukemia.

  • Relapsed or refractory chronic lymphocytic leukemia

    A cancer of mature B‑lymphocytes that accumulates in the blood, bone marrow, and lymphoid organs. Relapsed or refractory disease means the leukemia returns after therapy or fails to respond, resulting in a steady rise in abnormal lymphocytes.

Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525234-39-00Protocol code95804306EDI1001Estimated enrolment360 patientsSponsorJanssen Cilag International

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