About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects who can fully understand this trial and voluntarily sign the informed consent form (ICF) before any research-related procedures;
Histologically confirmed B-cell non-Hodgkin's lymphoma (B-NHL) with specified pathological subtypes;
Histologically confirmed CD19 and/or CD22 positivity;
Expected survival time exceeding 12 weeks;
Disqualifiers
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;
Prior allogeneic hematopoietic stem cell transplantation;
Systemic intravenous infusion treatment or uncontrollable bacterial, fungal or viral infection within 2 weeks before signing the ICF;
Trial design
Single group
Treatments tested in this trial
B019
DrugB019: Intravenous infusion, 2.0×10\^6 cell/kg-8.0×10\^6 cell/kg
Treatment groups
Trial outcomes
Primary outcomes
Dose-limiting toxicity (DLT)
Measurement of DLT of B019 in all subjects
MTD(Maximum tolerated dose)
Maximum tolerated dose
Secondary outcomes
The overall response rate (ORR)
Tumor response will be evaluated according to the Lugano 2014 criteria.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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