To hear about similar clinical trials, please enter your email below
Trial Title:
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228
NCT ID:
NCT05737628
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Rituximab
Conditions: Keywords:
mAB
Monoclonal antibody
Lymphoma
Non-Hodgkin's Lymphoma
SIRPα
NHL
CD20
CD47
SIRP
MCL
FL
MZL
DLBCL
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BYON4228 + Rituximab
Description:
20 mg/mL BYON4228 in 8 mL solution for infusion.
Rituximab 500 mg concentrate for solution for infusion.
Arm group label:
BYON4228 + Rituximab
Other name:
Truxima
Summary:
This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb)
directed against SIRPα.
Detailed description:
This study includes a dose escalation part (Part 1) in which the MTD and dose regimen for
expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy
and safety in specific patient cohorts.
BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed
on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228
blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ASST Spedali Civili di Brescia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Dr. A. Re
Facility:
Name:
Amsterdam Universitair Medisch Centrum locatie VUmc
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Dr. M. Chamuleau
Facility:
Name:
Radboud UMC
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Dr. W. Stevens
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Dr. F. Bosch Albareda
Facility:
Name:
Institut Català d'Oncologia
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Dr. E. Gonzalez Barca
Facility:
Name:
Centro Integral Oncológico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Dr. J. Perez De Oteyza
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Dr. K. Linton
Facility:
Name:
Derriford Hospital
Address:
City:
Plymouth
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Dr. D. Lewis
Start date:
March 4, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Byondis B.V.
Agency class:
Industry
Source:
Byondis B.V.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737628
