A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's L… (NCT06970496) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.
China48 participantsStarted 2026-08-31
Plain-language summary
The purpose of the study is to evaluate the safety、tolerability and preliminary efficacy of B019 in subjects with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subjects who can fully understand this trial and voluntarily sign the informed consent form (ICF) before any research-related procedures;
✓. At least one measurable lesion in two dimensions according to the Lugano 2014 criteria;
✓. Bone marrow, liver, kidney, and cardiac-pulmonary functions meeting the specified requirements; 8 Subjects who were evaluated by the researchers as tolerant to the collection of peripheral blood mononuclear cells (PBMC); 9 Subjects who were evaluated by the researchers as having no contraindications for lymphodepleting chemotherapy.
Exclusion criteria
✕. Primary central nervous system (CNS) lymphoma; However, secondary CNS lymphoma without clinical symptoms can be enrolled after being determined by the researchers；
✕. Use of the prescribed drugs or treatments within the specified time before the collection of PBMC;
✕. A history of deep vein thrombosis or pulmonary embolism or anticoagulant therapy within 6 months before signing the ICF;
✕. A clinically significant history of severe heart disease within 6 months before signing the ICF;
✕. Terminal organ damage or autoimmune diseases requiring systemic immunosuppressive/systemic treatments within 2 years before signing the ICF; Or have graft-versus-host disease;
✕. Prescribed malignant tumors within 5 years before signing the ICF;