None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : 1) Drug: Immuncell-LC(Activated T lymphocyte)
2) Dose: 1.0 × 10? to 2.0 × 10¹° cells / 200 mL
3) Number of administrations: 11 (five administrations at 1-week int
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients (or their legal guardians/representatives) who have received a comprehensive explanation of the study's purpose, procedures, and the characteristics of ImmunCell-LC and have voluntarily provided written informed consent 2) Patients aged 19 years or older at the time of screening 3) Patients with histopathologically confirmed IDH-wildtype glioblastoma (Grade 4) according to the WHO Classification of Tumours of the Central Nervous System, 5th edition (WHO CNS-5) 4) Patients who have undergone surgical resection (gross total resection or partial resection) for glioblastoma at least 2 weeks (14 days) prior to study initiation 5) Patients with a life expectancy of at least 3 months, as determined by the investigator 6) Patients with a Karnofsky Performance Status (KPS) score of = 60 7) Patients with adequate hematologic, renal, and hepatic functions, as determined by the investigator based on laboratory test results
Exclusion criteria
Exclusion criteria: 1) Patients with severe cardiopulmonary dysfunction, as determined by the investigator 2) Patients with a confirmed diagnosis of acquired immunodeficiency syndrome (AIDS) or a history of autoimmune diseases that may be exacerbated by immunotherapy (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, juvenile-onset insulin-dependent diabetes mellitus, T-cell lymphoma), or a history of severe allergic reactions 3) Patients receiving active treatment for another malignancy at the time of study initiation 4) Patients for whom autologous blood collection required for the manufacture of ImmunCell-LC is not feasible, as determined by the investigator 5) Pregnant or breastfeeding women 6) Women of childbearing potential and men who are unwilling to use adequate contraception from screening until completion of the follow-up period after the final administration of ImmunCell-LC and/or temozolomide 7) Patients who have participated in another interventional clinical trial within 4 weeks prior to study initiation (excluding non-interventional/observational studies) 8) Patients deemed unsuitable or unable to participate in the study by the investigator due to insufficient recovery from surgical resection or related therapies 9) Patients considered unsuitable for study participation by the investigator due to uncontrolled comorbidities or medical conditions requiring active treatment 10) Patients with confirmed active hepatitis B or hepatitis C virus infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival(OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS);Deterioration-free survival(DFS);Adverse Event | — |
Countries
Korea, Republic of
Contacts
Public ContactTae Hoon Roh
Yonsei University Health System, Severance Hospital
Outcome results
None listed