BYON4228 + Rituximab: BYON4228 is a humanized monoclonal antibody (mAb) directed against SIRPα. BYON4228 IV infusion every four weeks until disease progression or unacceptable toxicity. Different doses.
Rituximab IV infusion (375 mg/m2) starting from the second treatment cycle onwards. Weekly infusion during the first cycle and every four weeks in subsequent 5 cycles.
Study summary
This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Incidence of dose-limiting toxicities — 28 days Part 1
Trial sites (12)
Facility
City
Region
Status
ASST Spedali Civili di Brescia
Brescia
Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo
Italy
Instituto Europeo di Oncologia
Milan
Italy
IRCCS Ospedale San Raffaele
Milan
Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST
Ravenna
Italy
Vrije Universiteit Medisch Centrum
Amsterdam
Netherlands
Radboud UMC
Nijmegen
Netherlands
Hospital Universitari Vall d'Hebron
Barcelona
Spain
Institut Català d'Oncologia
Barcelona
Spain
Centro Integral Oncológico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.