Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 1/2
Where in South Korea
- Seoul National University HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TICAROS Co., Ltd.
- Trial code
- NCT07473167
- Record updated
- 16 March 2026
- Original description
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.Read full original descriptionShow less
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: 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: Unresolved ≥Grade 2 toxicities from prior therapy; Major surgery requiring general anesthesia within 4 weeks; 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; Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants); Malignancy within 2 years except specified exceptions; Significant cardiac disease within 6 months; Active HBV, HCV, HIV, syphilis; Rapidly progressing disease per investigator; Active or uncontrolled infection; Hypersensitivity to study drug components; CNS involvement by lymphoma; Pregnancy or breastfeeding.