Targeted Survivin DC Cell Injection for the Treatment of GBM
NCT Number: NCT06524063
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Glioblastoma
Interventions: DRUG: Survivin-loaded dendritic cell injection
Sponsor: Beijing Tricision Biotherapeutics Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-10-01

Summary:
Primary Objective: To evaluate the safety and tolerability of targeted Survivin DC cell injection for postoperative treatment of newly diagnosed primary glioblastoma multiforme. Secondary Objectives: Utilize progression-free survival (PFS) and overall survival (OS) to preliminarily assess the effectiveness of targeted Survivin DC cell injection for postoperative treatment of newly diagnosed primary glioblastoma multiforme in China. Evaluate the immunological effects of targeted Survivin DC cell injection. Explore the impact of targeted Survivin DC cell injection on human DC cell activity and in vivo processes.

Patients will undergo a combined treatment of radiotherapy and temozolomide (TMZ) for a duration of 6 weeks, with concurrent chemotherapy. After completing this phase, there will be a 4-week interval (28 days) before entering multiple cycles of adjuvant TMZ chemotherapy. Each cycle will last 28 days, involving daily oral administration of temozolomide at a dose of 150-200mg/m2 for 5 consecutive days, followed by a 23-day drug-free period. This entire cycle will be repeated every 28 days. Nine days after completing the standard 6-week concurrent chemoradiotherapy, targeted Survivin DC cell injections will be administered. The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes. Four hours before the administration, the injection sites will be pre-treated with lidocaine cream. The injection procedures will be conducted sequentially, starting with ID injection. After completing the ID injection, a 30-minute observation will be conducted. If no adverse reactions are observed, IV infusion will be initiated. Both IV infusion and ID injection will be performed on the same side. Intradermal Injection: Draw 1ml of cell suspension with a 1ml syringe, and the remaining cell product will be stored at 2-8℃. Administer the drug immediately after preparation. Intravenous Infusion: Before administration, infuse 20ml of normal saline through IV.Extract 25ml of normal saline, dilute the remaining cell product (5ml), and administer it through IV infusion. Control the room temperature during infusion and complete it within 30 minutes. After administration, inject 50ml of normal saline into the cell bag to ensure all cell products are returned to the patient's body.

Primary Outcome Measures: Dose Limiting Toxicity, The following adverse events that occurred within 28 days after the first dose to the third dose, as judged by the investigator, to be related to the study drug, 28 days
Secondary Outcome Measures: Progression Free Survival Progression Free Survival, The time from the date of first dose to the occurrence of disease progression or death due to any cause, 2 years|Overall Survival, The time from the date of first dose to death due to any cause in the subject, 2 years|Immune effect, Anti-Sauvignon antibody test;, 84 days|Cytokine, Cytokine (IL-6, IL-8, IL-10, TNF-α, IFN-γ, TGF-β) detection;, 56 days|Specific T cell responses, Specific T cell responses (Survivin-specific CD4+/CD8+ T cell responses), 84 days|DC cell activity and in vivo processes, The quantitative detection of the content of Survivin fusion gene in blood RNA was limited to the quantitative detection of the transcription level of Survivin fusion gene in patients., 35 days