Actively Recruiting
Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
Led by TICAROS Co., Ltd. · Updated on 2026-03-16
98
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years old or older
- ECOG performance status 0 to 2
- Life expectancy of at least 12 weeks
- Histologically confirmed B-cell lymphoma according to WHO 2017 criteria
- Relapsed or refractory after 2 or more prior systemic chemotherapy treatments
- At least one measurable lesion with longest diameter of 1.5 cm or more
- Adequate organ and lung function
- Left ventricular ejection fraction (LVEF) of 40% or higher
- Able to undergo leukapheresis procedure
- For those able to bear children, agreement to use effective contraception for at least 6 months after TC011 infusion
You will not qualify if you...
- Unresolved grade 2 or higher toxicities from previous treatments
- Any malignancy within the past 2 years except for specified exceptions
- Significant heart disease within the past 6 months
- Lymphoma involvement in the central nervous system
- Active infections with hepatitis B, hepatitis C, HIV, or syphilis
- Rapidly progressing disease as judged by the investigator
- Major surgery requiring general anesthesia within the past 4 weeks
- Active or uncontrolled infections
- Prior treatment with anti-CD19 agents, adoptive T-cell therapy, gene therapy, or allogeneic hematopoietic stem cell transplant
- Use of other investigational agents or immunosuppressants within protocol-specified time frames
- Pregnancy or breastfeeding
- Known allergy to any components of the study drug
- Recent chemotherapy, steroids, or immunosuppressants that prevent leukapheresis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
Research Team
A
Ah hyun Lim
CONTACT
A
admin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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