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New antibody combo takes aim at Hard-to-Treat lymphoma

NCT ID NCT05737628

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

Mar 2024

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • ASST Spedali Civili di Brescia

    Brescia, Italy

  • Centro Integral Oncológico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro

    Madrid, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • IRCCS Ospedale San Raffaele

    Milan, Italy

  • Institut Català d'Oncologia

    Barcelona, Spain

  • Instituto Europeo di Oncologia

    Milan, Italy

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST

    Ravenna, Italy

  • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS

    Candiolo, Italy

  • Radboud UMC

    Nijmegen, Netherlands

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • University Hospitals Plymouth NHS Trust

    Plymouth, United Kingdom

  • Vrije Universiteit Medisch Centrum

    Amsterdam, Netherlands

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