First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BY… (NCT05737628) | Clinical Trial Compass
Active — Not RecruitingPhase 1
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228
Italy17 participantsStarted 2024-03-04
Plain-language summary
This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
Who can participate
Age range18 Years
SexALL
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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 a…