🏛️ Verified NIH Record • Updated 2026-08-27

A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies (NCT07572006)

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

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Indiana Blood & Marrow Transplantation — Indianapolis, Indiana

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (15 Sites)

  • Indiana Blood & Marrow Transplantation — Indianapolis, Indiana
  • Start Midwest — Grand Rapids, Michigan
  • Rutgers Cancer Institute of New Jersey — Piscataway, New Jersey
  • NYU Langone Health — New York, New York
  • Sarah Cannon Cancer Institute — Nashville, Tennessee
  • MD Anderson Cancer Center - University of Texas — Houston, Texas
  • Peter MacCallum Cancer Centre — Melbourne,
  • UZ Antwerpen — Edegem,
  • Aarhus University Hospital — Aarhus N,
  • Institut Paoli Calmettes — Marseille,
  • CHU Lyon Sud — Pierre-Bénite,
  • Institut Claudius Regaud — Toulouse,
  • Hosp Univ Fund Jimenez Diaz — Madrid,
  • Clinica Univ. de Navarra — Pamplona,
  • The Christie Nhs Foundation Trust — Manchester,

📞 Contact the Study Coordinator

Phone: (844) 434-4210

Email: Participate-In-This-Study1@its.jnj.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗