Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients

A Multi-center, Single Arm, Open-label Phase 1/2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients

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.

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)