OncoMatch/Clinical Trials/NCT05189093
Recombinant Humanized Anti-CD47/PD-1 Bifunctional Antibody HX009 in Patients With Relapsed/Refractory Lymphoma
Is NCT05189093 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 for relapsed/refractory lymphoma.
Treatment: Recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 — This study is a multi-center, open, single-arm phase I/II clinical study to evaluate the recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in Chinese patients with relapsed/refractory lymphoma .
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Patients with relapsed/refractory diffuse large B-cell lymphoma (including transformed DLBCL): need to have received systemic therapy with at least two standard regimens
Must have received: systemic therapy
Relapsed/refractory follicular lymphoma and relapsed/refractory marginal zone lymphoma: at least two standard regimens of systemic therapy are required
Must have received: systemic therapy
Relapsed/refractory EBV-positive non-Hodgkin's lymphoma: at least one systemic regimen is required
Cannot have received: CD47-targeted therapy
patients who have received prior targeted therapy with CD47 (including monoclonal antibodies, bispecific antibodies, etc.)
Lab requirements
Blood counts
ANC ≥1.5 × 10/L; with bone marrow invasion, ANC ≥1.0 × 10/L; Platelets ≥75 × 10/L (without bone marrow invasion) and platelets ≥50.0 × 10/L (with bone marrow or spleen invasion); Hemoglobin (HB) ≥90 g/L; HB ≥80 g/L with bone marrow invasion
Kidney function
Creatinine clearance ≥ 45 mL/min (Cockcroft-Gault formula)
Liver function
Aspartate aminotransferase ≤ 2.0 x ULN, or ≤ 5.0 x ULN for hepatic invasion; Alanine aminotransferase ≤ 2.0 x ULN, or ≤ 5.0 x ULN in hepatic infestation; Total bilirubin ≤ 1.5 × ULN (except in Gilbert's syndrome or with hepatic or pancreatic invasion)
Cardiac function
Echocardiography: LVEF ≥ 45%
good major organ function, i.e., meeting the following criteria: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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