Overview
The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.
Description
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
Eligibility
Inclusion Criteria:
- Subjects voluntarily participate in clinical studies;
- ECOG score 0-1 points;
- Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and inert lymphoma transformed into diffuse large B-cell lymphoma; CD19 and/or CD20 positivity;
- At least one measurable tumor lesion determined according to Lugano's criteria: the longest diameter of intranodal lesions>1.5cm, and the longest diameter of extranodal lesions>1.0cm.
Exclusion Criteria:
- Received other chimeric antigen receptor therapy or gene modified cell therapy before screening;
- Subjects who were undergoing systemic steroid therapy during screening and were determined by the researchers to require long-term use of systemic steroid therapy during the treatment period (excluding inhalation or local use);
- Any unstable heart disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), and severe arrhythmia.