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Glioblastoma MultiformePhase 3NCT04277221

ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)

A Phase 3 study testing Autologous Dendritic Cell/Tumor Antigen, ADCTA in people with Glioblastoma Multiforme, run by Safe Save Medical Cell Sciences & Technology Co.,Ltd. at 7 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
Autologous Dendritic Cell/Tumor Antigen, ADCTA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
7 sitesTaiwan
Study dates
19 Sep 2019to 31 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Specimen collection screening
  • Karnofsky performance status (KPS) ≥ 60 at assessment prior to surgery
  • ≥ 18 and ≤ 70 years of age
  • Subject has been diagnosed with GBM and has undergone resection surgery followed by standard brain RT + concurrent temozolomide and adjuvant temozolomide, and progression occurred. The foregoing progression is defined as when patients with primary GBM experience an image or clinical deterioration after receiving standard of care.
  • Contrast-enhanced MRI suspects recurrent GBM
  • Supratentorial tumor
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  • Must voluntarily sign and date informed consent form for specimen acquisition and future use, for study screening, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures
  • Study screening
  • Karnofsky performance status (KPS) ≥ 60 at randomization
  • Submission of fresh tumor
  • Post-operation contrast-enhanced MRI scan must be done after surgical resection, with the intent for cyto-reduction ≥ 80% of the contrast-enhancing tumor mass
  • Histologically confirmed WHO grade IV glioma by pathology tissue screening
  • Subjects receiving bevacizumab as standard of care for given indication
  • Subject has adequate bone marrow, renal, and hepatic function prior to randomization as follow:
  • White blood cell (WBC) count ≥ 2,000/mm^3;
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
  • Platelets ≥ 100,000/mm^3;
  • Hemoglobin (Hgb) ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable.);
  • Blood Urea Nitrogen (BUN) < 30 mg/dL;
  • Creatinine < 2 mg/dL;
  • Renal function: calculated creatinine clearance ≥ 30 mL/min;
  • Hepatic function: Total bilirubin ≤ 3 times upper limit of normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN;
  • Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 times ULN unless therapeutically warranted.
  • Subjects with recurrent GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process
  • Must voluntarily sign and date informed consent form, for study participation, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures

Who cannot join

  • Specimen collection screening
  • Multifocal GBM
  • Prior invasive malignancy (except for non-melanomatous skin cancer; carcinoma in situ of breast, oral cavity or cervix) unless disease free for ≥ 2 years
  • Subject has used bevacizumab or immune checkpoint blockade to treat GBM
  • Lactating or pregnant female
  • Positive viral serology for HIV or syphilis at time of screening
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  • Study screening
  • Subjects having a biopsy only at surgery or tumor cell insufficiency at preparation
  • Inability to undergo contrast-enhanced MRI scans
  • Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia)
  • Inability to stop or decrease the use of corticosteroid doses to 4 mg/day prior to randomization
  • Tumor progression documented according to modified RANO criteria prior to randomization (approximately 5 weeks after surgery)
  • Severe, active comorbidity, defined as follow:
  • Subject with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness;
  • Subjects with acute hepatitis C or B infection;
  • Severe hepatic impairment (Child-Pugh category C or higher);
  • Electrocardiogram (ECG) with evidence of acute cardiac ischemia prior to randomization;
  • Transmural myocardial infarction or ischemia prior to enrollment;
  • Any other major medical illnesses or psychiatric impairments that in the Investigator's opinion will prevent administration or completion of protocol therapy
  • Subject used Gliadel wafer implant in surgery during screening process

Trial locations and contacts

7 sites in 1 country.

Wen-Kuang Yang, PhD contact

+886-3-5506696

wkyang@safesavecell.com.tw

Weber Liu, MS contact

+886-3-5506696

wbliu@safesavecell.com.tw

7 sites in 1 country

Taiwan7 sites, 7 recruiting

  • Chang Gung Memorial Hospital, Chiayi branch

    Chiayi City, 613

    Jen-Tsung Yang, MD/PhD, +886-5-3621000

    Jen-Tsung Yang, MD/PhD

    Recruiting

  • Chang Gung Memorial Hospital, Kaohsiung branch

    Kaohsiung City, 833

    Jih-Tsun Ho, MD/PhD, +886-7-7317123

    Jih-Tsun Ho, MD/PhD

    Recruiting

  • Chang Gung Memorial Hospital, Keelung branch

    Keelung, 204

    Pin-Yuan Chen, MD/PhD, +886-2-24313131

    Pin-Yuan Chen, MD/PhD

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Chiung-Chyi Shen, MD/PhD, +886-5-23592525

    Chiung-Chyi Shen, MD/PhD

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    E-Jian Lee, MD/PhD, +886-6-2353535

    E-Jian Lee, MD/PhD

    Recruiting

  • Chi Mei Medical Center

    Tainan, 710

    Chin-Hong Chang, MD, +886-6-2812811

    Chin-Hong Chang, MD

    Recruiting

  • Chang Gung Memorial Hospital, Linkou branch

    Taoyuan City, 333

    Peng-Wei Hsu, MD, +886-3-3281200

    Peng-Wei Hsu, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: Autologous Dendritic Cell / Tumor Antigen (ADCTA-SSI-G1) for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM): A Multi-center, Open-label, Randomized Phase III Clinical Trial

To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM.

Being tested
Autologous Dendritic Cell/Tumor Antigen, ADCTA
Keywords
Recurrent Glioblastoma Multiforme, Immunotherapy, Dendritic Cell
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Dendritic Cell/Tumor Antigen, ADCTABiological

    ADCTA is an individualized cell immunotherapy co-culturing autologous dendritic cells derived from peripheral blood mononuclear cells (PBMNCs) with autologous tumor cell as antigen in order to evoke specific immune response.

Study groups in NCT04277221
Study groupRoleWhat they receive
Standard therapy with ADCTA vaccine (study group)Experimental- ADCTA vaccine as study treatment Dose(s): Ten doses, including 2~4×10^7 cells for the 1st dose (double doses), and 1~2×10^7cells for the 2nd to 10th doses. Administrative route: The ADCTA vaccine will be injected in axillar or inguinal regions close to lymphnodes subcutaneously at clinic. Frequency: The primary immunization inoculation is followed by 3 vaccines bi-weekly and then 6 vaccines monthly inoculation, for a total of 10 doses. - Bevacizumab as standard therapy
Receives: Biological: Autologous Dendritic Cell/Tumor Antigen, ADCTA
Standard therapy (control group)Active comparator* No study treatment * Bevacizumab as standard therapy
Receives: Biological: Autologous Dendritic Cell/Tumor Antigen, ADCTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Measured: The duration will be calculated from the date of randomization until the date of death from any cause, assessed up to 60 months.

Secondary outcomes (3)

  1. Progression-free Survival (PFS)

    Measured: The duration will be calculated from the date of randomization until the date of first documented progression according to the modified RANO or date of death from any cause, whichever came first,assessed up to 60 months.

  2. Progression-free Survival at 6 months (PFS6)

    Measured: The duration will be calculated from the date of randomization to the date of the sixth month.

  3. 1 and 2-year Survival Rate

    Measured: The duration will be calculated from the date of randomization to the date of the first year and the second year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start19 Sep 2019
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277221
Sponsor's protocol ID
ADCTA-SSI-G1
Status last verified
Mar 2020
First submitted
14 Feb 2020
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chang CN, Huang YC, Yang DM, Kikuta K, Wei KJ, Kubota T, Yang WK. A phase I/II clinical trial investigating the adverse and therapeutic effects of a postoperative autologous dendritic cell tumor vaccine in patients with malignant glioma. J Clin Neurosci. 2011 Aug;18(8):1048-54. doi: 10.1016/j.jocn.2010.11.034. Epub 2011 Jun 28.

    PubMed 21715171

  • Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

    PubMed 32691060

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Autologous Dendritic Cell/Tumor Antigen, ADCTA in people with Glioblastoma Multiforme, run by Safe Save Medical Cell Sciences & Technology Co.,Ltd. at 7 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wen-Kuang Yang, PhD (+886-3-5506696, wkyang@safesavecell.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: The duration will be calculated from the date of randomization until the date of death from any cause, assessed up to 60 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277221, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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