Actively Recruiting
Evaluate the Efficacy and Safety of 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
394 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 75 years at tumor resection surgery
- Newly diagnosed single primary glioblastoma (WHO grade IV) outside brainstem or cerebellum
- Undergoing craniotomy tumor removal with tumor cells preserved for ADCV01 production
- Tumor resection using neuro-navigation without intracranial implantation therapies
- Only one GBM tumor present
- Able to understand and sign informed consent
- Expected life expectancy greater than 12 weeks
- Stable vital signs and Karnofsky Performance Status (KPS) of at least 70
- Adequate kidney function: serum creatinine less than 1.8 mg/dL and creatinine clearance over 30 mL/min
- Adequate liver function: AST, ALT, ALP no more than 3 times upper limit of normal and total bilirubin under 3 mg/dL
- Prothrombin time and activated partial thromboplastin time no more than 1.5 times upper limit of normal
- Adequate blood cell counts: neutrophils at least 1,000 cells/µL, platelets at least 100,000/µL, white blood cells at least 2,000 cells/µL, hemoglobin at least 8 g/dL
- Use of effective birth control or sexual abstinence before and during the study if of child-bearing potential
- Agree to comply with study treatment plan
- Tumor confirmed as IDH-1 wild-type GBM and low PD-1/CD8 ratio less than 0.21
- Residual tumor less than 25% of original size on MRI within 2 days after surgery
You will not qualify if you...
- More than one GBM tumor
- Participation in other investigational studies within 4 weeks prior to pre-screening
- Known or suspected allergy to ADCV01 or its ingredients
- History of severe allergic reactions to dacarbazine, temozolomide, or bevacizumab
- Acute infection or cardiovascular disease, including recent myocardial infarction or uncontrolled hypertension
- Significant immune system disorders or HIV infection
- Active autoimmune diseases or certain rheumatic conditions
- Psoriasis requiring systemic therapy or conditions likely to recur with external triggers
- Certain infectious diseases including active hepatitis B or C, syphilis, or transmissible spongiform encephalopathies
- History of bleeding or clotting disorders
- Medical, social, or psychological issues interfering with study compliance
- Pregnant or breastfeeding women
- Unable to undergo MRI
- History of other malignancies not stable for 5 years
- GBM tumors with high PD-1/CD8 ratio (0.21 or higher) or mutant IDH-1
- Residual tumor volume greater than 25% of pre-operative tumor size
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
W
Wen-Liang Huang
CONTACT
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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