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Targeted Survivin DC Cell Injection for the Treatment of GBM

NCT06524063 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Survivin-loaded dendritic cell injection

The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes.

Sponsors & Collaborators

  • Beijing Tricision Biotherapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-12-01
Completion
2027-10-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524063 on ClinicalTrials.gov