JNJ-95804306 in relapsed or refractory blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial has two parts: a dose-escalation portion to determine a safe and potentially effective dose (RP2D) of JNJ-95804306, and a dose-expansion portion to further assess safety and look for anti-tumor activity at the RP2D with or without standard-of-care therapy in hematological malignancies. Participants include those with AML/MDS in Arm A and CLL/SLL in Arm B who have exhausted other treatment options. The study will explore safety, tolerability, and preliminary signals of efficacy to guide future trials. Sites are in Indiana, Michigan, and New Jersey.

Why it matters

Who can join: the full rules

Inclusion criteria:

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 criteria:

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)

Where it's running

• Indiana Blood & Marrow Transplantation
  Indianapolis, Indiana, United States Recruiting
• Start Midwest
  Grand Rapids, Michigan, United States Recruiting
• Rutgers Cancer Institute of New Jersey
  Piscataway, New Jersey, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting
• Sarah Cannon Cancer Institute
  Nashville, Tennessee, United States Recruiting
• MD Anderson Cancer Center - University of Texas
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.