🏛️ Verified NIH Record • Updated 2026-08-27

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (NCT05424822)

A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

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

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D\[s\]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).

Location: City of Hope — Duarte, California

Age range: 18 Years

🧪 Interventions in This Study

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
  • Prior solid-organ transplantation
  • Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
  • Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade \<= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
  • Clinically significant pulmonary compromise, particularly the need for supplemental oxygen use to maintain adequate oxygenation

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (29 Sites)

Showing the first 25 of 29 sites.

  • City of Hope — Duarte, California
  • Icahn School of Medicine at Mount Sinai — New York, New York
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • Sarah Cannon Research Institute — Nashville, Tennessee
  • The University of Texas MD Anderson Cancer Center — Houston, Texas
  • Texas Transplant Institute — San Antonio, Texas
  • Seattle Cancer Care Alliance — Seattle, Washington
  • Macquarie University Hospital — Macquarie University,
  • The Alfred Hospital — Melbourne,
  • Linear Clinical Research Ltd — Nedlands,
  • Scientia Clinical Research — Randwick,
  • Chongqing University Cancer Hospital — Chongqing,
  • Sun Yat Sen University Cancer Center — Guangzhou,
  • Tianjin cancer hospital — Tianjin,
  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology — Wuhan,
  • Rigshospitalet — Copenhagen,
  • Odense University Hospital — Odense,
  • CHRU de Lille Hopital Claude Huriez — Lille,
  • Institut Curie — Paris,
  • Institut de Cancerologie Strasbourg Europe ICANS — Strasbourg,
  • Institut Universitaire du cancer de Toulouse-Oncopole — Toulouse,
  • Carmel Medical Center — Haifa,
  • Hadassah Medical Center — Jerusalem,
  • Tel Aviv Sourasky Medical Center — Tel Aviv,
  • National Cancer Center Hospital East — Kashiwa,

📞 Contact the Study Coordinator

Phone: (800) 826-4673

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.

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💡 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 ↗