RecruitingPhase 1Phase 2NCT07473167

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

Sponsor

TICAROS Co., Ltd.

Enrollment

98 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)Primary Mediastinal Large B-cell Lymphoma (PMBCL)Relapsed Large B-cell Lymphoma Refractory Large B-cell Lymphoma Transformed Follicular Lymphoma (tFL)High-grade B-cell Lymphoma (HGBL)

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

Min Age: 19 Years

Inclusion Criteria9

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 Criteria13

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)

Interventions

DRUGTC011

Anti-CD19 Chimeric Antigen Receptor T cell

Locations(1)

Seoul National University Hospital

Seoul, Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07473167

Related Trials

A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

NCT0718855839 locations

A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma

NCT064860513 locations