A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (NCT05283720)
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
🩺 Plain-English Summary (8th-Grade Level)
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Who can join: Review the eligibility criteria below.
Location: The University of Arizona Cancer Center - North Campus /ID# 242219 — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (76 Sites)
Showing the first 25 of 76 sites.
- The University of Arizona Cancer Center - North Campus /ID# 242219 — Tucson, Arizona
- Yale University School of Medicine /ID# 242089 — New Haven, Connecticut
- Christiana Care Health Service /ID# 242301 — Newark, Delaware
- Tampa General Hospital /ID# 246748 — Tampa, Florida
- Winship Cancer Institute of Emory University /ID# 242153 — Atlanta, Georgia
- University of Maryland, Baltimore /ID# 242218 — Baltimore, Maryland
- Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144 — Kansas City, Missouri
- Northwell Health - Monter Cancer Center /ID# 245435 — Lake Success, New York
- Icahn School of Medicine at Mount Sinai /ID# 242123 — New York, New York
- Novant Health Presbyterian Medical Center /ID# 242148 — Charlotte, North Carolina
- East Carolina University - Brody School of Medicine /ID# 242506 — Greenville, North Carolina
- Novant Health Forsyth Medical Center /ID# 242198 — Winston-Salem, North Carolina
- Thomas Jefferson University Hospital /ID# 242077 — Philadelphia, Pennsylvania
- Fox Chase Cancer Center /ID# 242106 — Philadelphia, Pennsylvania
- Thompson Cancer Survival Ctr /ID# 242150 — Knoxville, Tennessee
- Joe Arrington Cancer Research /ID# 242226 — Lubbock, Texas
- Swedish Medical Center - Seattle /ID# 242269 — Seattle, Washington
- MultiCare Institute for Research and Innovation /ID# 242127 — Tacoma, Washington
- Beijing Cancer Hospital /ID# 252303 — Beijing, Beijing Municipality
- Fudan University Shanghai Cancer Center /ID# 252292 — Shanghai, Shanghai Municipality
- Fakultni Nemocnice Brno - Jihlavska /ID# 242683 — Brno, Brno-mesto
- Fakultni Nemocnice Ostrava /ID# 242684 — Ostrava, Ostrava-mesto
- Vseobecna Fakultni nemocnice v Praze /ID# 242685 — Prague, Praha 17
- Fakultni nemocnice Hradec Kralove - Sokolska /ID# 241722 — Hradec Králové,
- Aarhus Universitetshospital - Skejby /ID# 242670 — Aarhus, Central Jutland
💰 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.
More studies in Non-Hodgkin Lymphoma
- A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma — Duarte, California
- A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies — Mobile, Alabama
- AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma — St Louis, Missouri
- Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma — Chicago, Illinois
- Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy — St Louis, Missouri
Explore by condition: All Non-Hodgkin Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.