A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

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

Qualifiers

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

Treatments tested in this trial

  • B019

Treatment groups

48 Participants
are divided into 1 treatment group