Predictors of Response to Autologous Dendritic Cell Therapy in Glioblastoma Multiforme.
Chia-Ing Jan, Wan-Chen Tsai, Horng-Jyh Harn...
https://pubmed.ncbi.nlm.nih.gov/29910795Actively Recruiting
Phase 2
Age: 20Years - 75Years
All Genders
ID04115761
A Phase II, Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Autologous Dendritic Cell Vaccination (ADCV01) As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients
Led by Ever Supreme Bio Technology Co., Ltd. · Updated on 2024-09-19
24
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of autologous dendritic cell vaccination (ADCV01) as an additional treatment for patients newly diagnosed with primary glioblastoma multiforme (GBM), a severe brain tumor with high mortality and limited survival even after standard therapies. The study focuses on patients with a specific immune profile characterized by low PD-1/CD8 ratio, which may influence treatment response. This is a phase II, open-label, randomized trial designed to compare the add-on immunotherapy with conventional treatment alone. Participants will be divided into two groups: one receiving the standard care of surgery, radiotherapy, and chemotherapy with Temozolomide (TMZ), and the other receiving the same standard care plus 10 doses of ADCV01. ADCV01 is made from the patient's own dendritic cells stimulated by their tumor antigens and administered via injections into lymph nodes at varying intervals over several months. The control group will receive only the conventional treatment. Both groups will be monitored closely, and if GBM recurs, treatments may shift to anti-angiogenic therapy (Avastin). Throughout the study, patients will undergo regular tumor assessments using MRI scans and clinical evaluations based on established criteria for brain tumors. Researchers will measure progression-free survival at one year as the primary outcome, alongside safety and response evaluations. Additional assessments include blood tests, neurological exams, and monitoring of vital signs and immune markers. The total participation duration varies, with ongoing follow-up to assess treatment effects and disease progression until the study's end in late 2026.
CONDITIONS
Brief Title
Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients
Who Can Participate
Age: 20Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 20 to 75 years at the time of brain tumor resection surgery
- Newly diagnosed single primary WHO grade IV glioblastoma outside the brainstem or cerebellum
- Scheduled for craniotomy tumor excision and willing to preserve tumor cells for ADCV01 production
- Undergoing tumor resection without intracranial implantation therapies
- Able to understand and sign informed consent and aware of the investigational nature
- Expected life expectancy greater than 12 weeks
- Stable vital signs and Karnofsky Performance Status (KPS) of 70 or higher
- Adequate kidney, liver, and blood clotting functions as specified
- Adequate hematopoietic function before treatment
- Use of medically acceptable birth control methods for those with child-bearing potential
- Compliance with the clinical protocol treatment plan
- Resected tumor confirmed as IDH-1 wild-type glioblastoma with low PD-1/CD8 ratio (<0.21)
- Residual tumor less than 25% of pre-operative size on MRI within 2 days post-operation
You will not qualify if you...
- More than one glioblastoma tumor
- Participation in other investigational studies within 4 weeks prior to screening
- Known hypersensitivity to ADCV01 or its components
- History of severe allergic reactions to dacarbazine, temozolomide, or bevacizumab
- Acute infectious or cardiovascular diseases, recent heart attack, or uncontrolled hypertension
- Significant immune system compromise unrelated to corticosteroid use, HIV infection, or requiring immune-suppressive treatments
- Active rheumatic, collagen vascular, autoimmune, or certain neurologic autoimmune disorders
- Psoriasis requiring systemic therapy or conditions likely to recur with external triggers
- Certain infections or risk of transmissible spongiform encephalopathies
- History of bleeding or clotting disorders
- Medical, social, or psychological factors affecting study compliance
- Pregnancy, lactation, or planning pregnancy
- Inability to undergo MRI
- History of unstable malignancies other than glioma within the past 5 years
- High PD-1/CD8 ratio (≥0.21) or mutant IDH-1 tumor status
- Residual tumor volume exceeding 25% of pre-operative tumor size after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Approximately 6 months or until completion of 10 ADCV01 doses and chemotherapy cycles
Participants undergo tumor resection, then receive standard radiotherapy plus chemotherapy. Those in the investigational group also receive 10 doses of ADCV01 as an add-on treatment administered weekly, bi-weekly, and then every 4 weeks.
Weekly visits for the first 4 ADCV01 doses, bi-weekly visits for the next 2 doses, and monthly visits for the last 4 doses; chemotherapy and radiotherapy visits as scheduled
Follow-up
Duration - Up to 12 months or until disease progression
Participants are monitored with scheduled evaluations approximately every 8 weeks to assess tumor response and progression.
Visits approximately every 8 weeks
Trial Site Locations
Total: 3 locations
1
Taichung Veterans General Hospital
Taichung, Non-US, Taiwan, 407
Actively Recruiting
2
Chang-Gung Memorial Hospital at Lin-Ko
Taoyuan, Non-US, Taiwan, 333
Actively Recruiting
3
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
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Research Team
W
Wen-Liang Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Progression-free survival as a surrogate endpoint for overall survival in glioblastoma: a literature-based meta-analysis from 91 trials.
Kelong Han, Melanie Ren, Wolfgang Wick...
https://pubmed.ncbi.nlm.nih.gov/24335699Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma.
Roger Stupp, Warren P Mason, Martin J van den Bent...
https://pubmed.ncbi.nlm.nih.gov/15758009