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

NCT07473167 · TICAROS Co., Ltd.
In plain English

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Official title
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
About this study
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 criteria
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)
Study design
Enrollment target: 98 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-08-03
Estimated completion: 2028-03-10
Last updated: 2026-03-16
Interventions
Drug: TC011
Primary outcomes
  • Phase1: Occurrence of Dose-Limiting Toxicities (DLTs) (Up to 4 weeks after TC011 infusion)
  • Phase1: Determination of Maximum Tolerated Dose (MTD) (up to 4weeks after TC011 infusion)
  • Phase1: Determination of Recommended Phase 2 Dose (RP2D) (Up to 12 weeks after TC011 infusion)
Sponsor
TICAROS Co., Ltd. · industry
Contacts & investigators
ContactAh hyun Lim · contact · ah.lim@ticaros.com · 82+1029985238
Contactadmin · contact · admin@ticaros.com
All locations (1)
Seoul National University HospitalRecruiting
Seoul, Seoul, South Korea