Overview
This is a multi-center, phase I/II study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.
Eligibility
Inclusion Criteria:
Subjects must meet all criteria including:
- ≥19 years old, ECOG 0-2, life expectancy ≥12 weeks
- Histologically confirmed B-cell lymphoma (WHO 2017)
- Relapsed/refractory after ≥2 prior lines of systemic chemotherapy
- ≥1 measurable lesion (longest diameter ≥1.5 cm)
- Adequate organ, and pulmonary function
- LVEF ≥40%
- Able to undergo leukapheresis
- For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion
Exclusion Criteria:
- Unresolved ≥Grade 2 toxicities from prior therapy
- Malignancy within 2 years except specified exceptions
- Significant cardiac disease within 6 months
- CNS involvement by lymphoma
- Active HBV, HCV, HIV, syphilis
- Rapidly progressing disease per investigator
- Major surgery requiring general anesthesia within 4 weeks
- Active or uncontrolled infection
- Prior therapies such as anti-CD19 agents, adoptive T-cell therapy, gene therapy, allogeneic HSCT
- Use of other investigational agents, immunosuppressants within protocol-specified windows
- Pregnancy or breastfeeding
- Hypersensitivity to study drug components
- Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants)
