New antibody combo takes aim at Hard-to-Treat lymphoma
NCT ID NCT05737628
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new lab-made antibody called BYON4228, alone or with the cancer drug rituximab, in 17 people with relapsed or refractory B-cell non-Hodgkin lymphoma. The goal is to check safety and find the right dose. It's the first time this drug is being tested in humans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BYON4228 (a lab-made antibody) combined with rituximab (a cancer drug)
- What this could lead to
- If it works, this could point toward a new treatment option for people with certain types of lymphoma that haven't responded to other therapies.
- What could go wrong
- This is a very early (Phase 1) and small trial (17 people), so it's mainly checking safety. The drug may not work well or could have side effects, and it's too soon to know if it will help patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Part 1 (dose escalation): B-cell NHL expressing CD20 by immunohistochemistry (IHC) or flow cytometry, relapsed/refractory (R/R) to at least 2 prior lines of therapy. * Part 2 (dose expansion): A. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) or Mantle Cell Lymphoma (MCL) expressing CD20 by IHC or flow cytometry, R/R to frontline therapy. B. Histologically confirmed marginal zone or follicular lymphoma (Grade 1-3a) expressing CD20 by IHC or flow cytometry, R/R to at least 2 prior lines of therapy. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1; * Adequate organ function; * Laboratory measurements, blood counts (Growth Factor (GF) support and blood transfusions are not allowed within 2 weeks prior to this assessment): * Hemoglobin ≥ 8.5 g/dL (\> 5.28 mmol/L); * Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/mL; * Platelet counts ≥ 50 × 10\^9/mL; Exclusion Criteria: * Having been treated with CD47 or SIRPα targeting agents at any time or other anticancer therapy within 4 weeks or as defined in the protocol; * History of hypersensitivity or allergic reaction to any of the excipients of BYON4228 or rituximab which led to permanent discontinuation of the treatment; * Burkitt's lymphoma; * Red blood cell (RBC) transfusion dependence; * Patients with active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD; * History of autoimmune hemolytic anemia or autoimmune thrombocytopenia; * History of active autoimmune disorders (including but not limited to: Crohn's disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease) or other conditions that compromise or impair the immune system (except for hypogammaglobulinemia); * History (within 6 months prior to start IMP) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication; * Currently diagnosed or suspected CNS involvement; * Severe active infection or other severe uncontrolled systemic disease (e.g. advanced renal disease, pulmonary, uncontrolled diabetes mellitus, severely immunocompromised state, or metabolic disease)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Spedali Civili di Brescia
Brescia, Italy
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Centro Integral Oncológico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro
Madrid, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, Spain
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IRCCS Ospedale San Raffaele
Milan, Italy
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Institut Català d'Oncologia
Barcelona, Spain
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Instituto Europeo di Oncologia
Milan, Italy
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST
Ravenna, Italy
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Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Italy
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Radboud UMC
Nijmegen, Netherlands
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The Christie NHS Foundation Trust
Manchester, United Kingdom
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University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
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Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
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- Reprogrammed immune cells target CD30-Positive lymphoma in early trial
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- Double-Drug attack on Hard-to-Treat lymphomas
- Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma