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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
⁃ 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
Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Ah hyun Lim
ah.lim@ticaros.com
82+1029985238
Backup
admin
admin@ticaros.com
Time Frame
Start Date: 2023-08-03
Estimated Completion Date: 2028-03-10
Participants
Target number of participants: 98
Treatments
Experimental: TC011
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011.
Related Therapeutic Areas
Sponsors
Leads: TICAROS Co., Ltd.