None listed
Conditions
Interventions
Genetic : A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2.5X10^5~ 2.5 x 10^6 CAR T cells/kg(Product name_TC011)/ tr
Sponsors
TiCARos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [PAHSE 1] • =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) • Subjects whose renal, liver, hematologic functions, and Pulmonary reserve are confirmed • LVEF(Left Ventricular Ejection Fraction) =40% • Able to undergo leukapheresis • For subjects of childbearing potential: agreement to use effective contraception for =6 months after TC011 infusion [PAHSE 2] • Histologically confirmed Diffuse large B-cell lymphoma (including transformed Follicular lymphoma), high grade B cell lymphoma (including double/triple hit high grade B cell lymphoma), or Primary mediastinal B-cell lymphoma • Relapsed/refractory after =2 regimens containing rituximab and anthracycline, and ineligible for or failed autologous stem-cell transpl
Exclusion criteria
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, oral anticoagulation therapy, • A person who has received or applied other investigational product or medical devices within 4 weeks of screening • Pregnancy or breastfeeding • Hypersensitivity to study drug components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Phase 1] Maximum tolerance dose, adverse events, Replication competent lentivirus | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, Complete Response (CR),Partial Response (PR) rates | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung il Go
Seoul National University Hospital
Outcome results
None listed