NCT07473167RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- 3 Aug 2023
- Primary completion date
- 11 Feb 2028
- Lead sponsor
- TICAROS Co., Ltd.
- NCT number
- NCT07473167
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 98
- From 3 Aug 2023 to the primary completion date, 11 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- CNS involvement by lymphoma
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.