A Phase 2 interventional study of autologous dendritic cells in GBM, sponsored by Ever Supreme Bio Technology Co., Ltd.. Recruiting at 3 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Ever Supreme Bio Technology Co., Ltd. · Phase 2, Interventional, and Treatment
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
The patients with primary glioblastoma multiforme (GBM) have high mortality and morbidity. Even with best conventional therapy (surgery, radiation, and chemotherapy), the most of median survivals are less than 2 years. The one-year progression-free survival (PFS) is less than 20%. Recently, the immune therapy is a new promising therapy for GBM from the evidences of published experimental data and clinical trials.
However, the outcomes of immune therapy are still equivocal. The critical point of immune therapy is strongly influenced by tumor microenvironment. Up to now, for example, immune checkpoint inhibitor such as programmed cell death protein ligand 1 (PD-L1) and programmed cell death protein 1 (PD-1) was found to induce exhaustion of CD8 T cell by of PD-1/PD-L1 reaction. Unfortunately, GBM cells always have high PD-L1 expression. It means the higher PD-1 level of T-cell indicates the higher immune suppression by GBM tumor cells.
In the investigators preclinical study, the best murine survival was found to be the combination outcome of dendritic cell (DC) with anti-PD-1 therapy which was better than that of DC therapy only. From previously ADCV-treated patients, the median of PD-1/CD8 was 0.21. When the PD-1/CD8 ratio less than 0.21, this patient is defined as with low PD-1 level.
From the investigators previous experience, patients with low PD-1/CD8 ratio had far better 2-year overall survival (OS) than patients with high PD-1/CD8 ratio in ADCV treatment. On the other hand, it showed that OS and PFS had significant reverse correlation with PD-1 level of Tcell during DC immunotherapy. Considering the needs and benefit of patients, the new autologous dendritic cell vaccine (ADCV01) is proposed to be added on conventional therapy in low PD-1 expressed GBM patients and evaluate its safety and efficacy.
In this study, only newly diagnosed primary GBM (wild-type Isocitrate Dehydrogenase 1, IDH-1) patients will be enrolled in this clinical trial. In addition to fulfilling all inclusion criteria without matching any of the exclusion criteria, patients will undergo tumor resection and less than 25% of residual tumor size, followed by being subjected to histological analysis. Examinations of molecular diagnostics including IDH-1 for confirmation of IDH-1 wild-type GBM according to the 2016 WHO Classification of Tumors of the Central Nervous System, and cut-off criteria for expression levels of PD-1 and CD8 (PD-1/CD8 ratio less than 0.21) will be screened for the eligibility to participate in this study and MGMT status will also be determined.
After tumor resection, all eligible patients will receive standard radiotherapy (RT) plus Temozolomide (Temodal, TMZ), followed by adjuvant treatment of TMZ. Patients assigned to the investigational group will receive ADCV01 administration as an add-on treatment after operation in this study.
This study aims to treat eligible patients with ADCV01 as an add-on immunotherapy along with post-surgery GBM treatment and compare the treatment to the conventional therapy (RT plus standard TMZ chemotherapy) alone on the basis of PFS in an unbalanced allocation (investigational group : control group = 2:1). After tumor resection, patients assigned to the control group will receive RT plus TMZ, followed by the scheduled evaluation visits. For patients assigned to the investigational drug group, a standard of 10 doses of ADCV01 (2±0.5 × 10\^7 cell/dose) in addition to conventional therapy will be administered.
The assessment of tumor response is based on [Update Response Assessment Criteria for High-Grade Gliomas, Response Assessment in Neuro-Oncology (RANO)] assessed by the on-site investigator and Blinded Independent Central Review (BICR) independently. If needed, the repeat operation for decompressive craniotomy evaluated by the on-site neurosurgeon for relief of increased intracerebral pressure (IICP), or for lifesaving will be allowed in both groups. However, in this study, the reoperation for recurrent tumor will be allowed.
RT will be given if feasible considering the total RT accumulatively given is not enough when tumor recurs (total dose 60 Gy). Gamma knife will not be used for recurrent tumor in this study which is different application from previous research.
Regardless of receiving re-operation or not in both groups, TMZ treatment will be shifted to anti-angiogenic therapy (AVASTIN®) 10 mg/kg/2weeks for 6 doses after patients have recurrence of GBM. Pseudo-progression may lead to either premature termination of therapy or unnecessary debulking surgeries. Therefore, adjuvant TMZ is recommended to be continued for a minimum of 3 cycles (along with ADCV01 treatment in the first 3 months of the adjuvant TMZ period), after which other imaging techniques (e.g., Gdenhancing MRI and proton magnetic resonance spectroscopy) should be used to ascertain progression. TMZ is not continuously used whenever recurrence. On this end, the treatment course is complete.
If the recurrent GBM in patients assigned to the investigational group is occurred before completing 10 doses of ADCV01 treatments, the patient will be treated by the remaining ADCV01 and complete the originally scheduled treatment.
In this phase II study, 24 eligible primary GBM patients who are with low PD-1/CD8 ratio will be recruited. There will be 16 patients with combination of ADCV01 and conventional therapy, and 8 patients with conventional therapy only. In this trial, the treatment efficacy of ADCV01 measured by one-year PFS rate will be evaluated at the end of phase II study. Because PFS was surrogate endpoint of overall survival in GBM by literature-based meta-analysis from 91 clinical trials, the 1-year PFS rate will be the primary endpoint of GBM clinical trial.
This study is designed with open-label and randomized parallel group. To date, 34 clinical trials of DC for GBM published up to 2017 in ClinicalTrials.gov, there are 5/34 trials designed by double blinded method and 2/34 trials by single blinded and most of 27/34 trials by open-label (please see ref. ClinicalTrials.gov). The other reason for open-label is that the apheresis for control patients is an invasive procedure. GBM is a not easily curable disease; patients with MGMT methylation have a better survival than with unmethylation. In this trial, MGMT status will be evaluated in all tumor specimens for further subgroup analysis.
Ever Supreme Bio Technology Co., Ltd. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stage I (Pre-screening)
Patients with adequate renal function at the pre-screening visit:
serum creatinine \< 1.8 mg/dL; > 30 mL/min
Patients with adequate liver function at the pre-screening visit:
, ALT, and ALP ≤ 3× (ULN); and total \< 3 mg/dL
Patients with adequate hematopoietic function at the prescreening and before administration of study medication
All male and female patients with (between puberty and 2 years after menopause) must be practicing sexual abstinence and be willing to continue to use a medically acceptable form of for at least 1 month prior to screening (that period will extend to 3 months for oral contraceptive use). The patients should use appropriate contraceptive method(s) as shown below, until at least 6 months after the last dose of ADCV01 administration.
(d.1+d.2 or d.1+d.3, or d.2+d.3): d.1 Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception. d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Patients agree to be in compliance with treatment plan as planned in the clinical protocol.
Stage II (Screening/Randomization) In addition to fulfill the criteria in Stage I, following criteria should be met to be eligible for remaining in the study.
Exclusion Criteria:
Stage I (Pre-screening)
Patient not suitable to participate the trial as judged by the investigator. Stage II (Screening/Randomization)
The patient will be no longer eligible to participate the study if he/she met any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ADCV01 is autologous dendritic cells (DCs) stimulated by the patients' own tumor antigens. The total 10 doses (1 mL/dose; 2±0.5 × 10\^7 cell/dose) of ADCV01 will be administered to patients assigned to the investigational group. The ADCV01 will be administered to the bilateral subaxillary subcutaneous regional lymph nodes (half of volume about 0.5 mL of ADCV01) once weekly for the first 4 doses, and the following 2 treatments will be administered bi-weekly. The last 4 treatments will be administered every 4 weeks.
Biological: autologous dendritic cells
the conventional treatment (RT and chemotherapy) will be given after tumor resection, followed by subsequent evaluations by an approximately 8-week interval.
Biological: autologous dendritic cells
The total 10 doses (1 mL/dose; 2±0.5 × 10\^7 cell/dose) of ADCV01 will be administered to patients assigned to the investigational group. The ADCV01 will be administered to the bilateral subaxillary subcutaneous regional lymph nodes (half of volume about 0.5 mL of ADCV01) once weekly for the first 4 doses, and the following 2 treatments will be administered bi-weekly. The last 4 treatments will be administered every 4 weeks.
One-year progression-free survival (PFS) rate
The PFS is defined as the time from randomization until the tumor objective progression or death, whichever occurs first.
Time frame: the percentage of patients surviving 1 year after randomization without objective tumor progression or death.
Plan to share: No
Started Jun 2019 (actual). Primary completion is estimated for Dec 2027, 102 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Ever Supreme Bio Technology Co., Ltd.