Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524063
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Targeted Survivin DC Cell Injection for the Treatment of GBM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Clinical Study of Targeted Survivin DC Cell Injection for the Treatment of Newly Diagnosed Primary Glioblastoma Multiforme GBM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 150-200mgm2 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 IVExtract 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 patients body
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 150-200mgm2 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 IVExtract 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 patients body
Detailed Description:
The trial was designed as an open-label dose-escalation trial This study is divided into two phases a dose escalation phase and an expansion cohort phase
Dose escalation phase This project is for 3 immunizations and the tolerability and efficacy of 3 immunizations are evaluated
Expansion cohort phase Based on the safety and efficacy data of the dose escalation phase combined with safety and immune effect indicators the dosage and sample size of the expansion cohort study were formulated their safety and efficacy were evaluated and the appropriate dose was recommended for subsequent clinical trials
The sample size of the dose escalation test was planned to be 918 cases and the number of cases in the expansion cohort study was estimated according to the data of the previous dose escalation test
A total of 3 dose groups were set up for Survivin DC cell injection which were 1107 DCs 2107 DCs and 3107 DCs and the preparation specification was 6ml Intradermal administration and intravenous administration are allocated according to a ratio of 15 1ml intradermally and 5ml intravenously
Dose escalation phase This project is for 3 immunizations and the tolerability and efficacy of 3 immunizations are evaluated
Expansion cohort phase Based on the safety and efficacy data of the dose escalation phase combined with safety and immune effect indicators the dosage and sample size of the expansion cohort study were formulated their safety and efficacy were evaluated and the appropriate dose was recommended for subsequent clinical trials
The sample size of the dose escalation test was planned to be 918 cases and the number of cases in the expansion cohort study was estimated according to the data of the previous dose escalation test
A total of 3 dose groups were set up for Survivin DC cell injection which were 1107 DCs 2107 DCs and 3107 DCs and the preparation specification was 6ml Intradermal administration and intravenous administration are allocated according to a ratio of 15 1ml intradermally and 5ml intravenously
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None