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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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 - 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 2.
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: 1.
White blood cell (WBC) count ≥ 2,000/mm^3; 2. Absolute neutrophil count (ANC) ≥ 1,000/mm^3; 3. Platelets ≥ 100,000/mm^3; 4. Hemoglobin (Hgb) ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable.); 5. Blood Urea Nitrogen (BUN) < 30 mg/dL; 6. Creatinine < 2 mg/dL; 7. Renal function: calculated creatinine clearance ≥ 30 mL/min; 8. Hepatic function: Total bilirubin ≤ 3 times upper limit of normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN; 9. 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

    Exclusion Criteria:

    1.
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 2.
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: 1.
Subject with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness; 2. Subjects with acute hepatitis C or B infection; 3. Severe hepatic impairment (Child-Pugh category C or higher); 4. Electrocardiogram (ECG) with evidence of acute cardiac ischemia prior to randomization; 5. Transmural myocardial infarction or ischemia prior to enrollment; 6. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04277221
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Safe Save Medical Cell Sciences & Technology Co.,Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Peng-Wei Hsu, MD
Principal Investigator Affiliation Chang Gung Memorial Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Standard therapy with ADCTA vaccine (study group)

- 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

Active Comparator: Standard therapy (control group)

No study treatment Bevacizumab as standard therapy

Interventions

Biological: - Autologous Dendritic Cell/Tumor Antigen, ADCTA

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chiayi City, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital, Chiayi branch

Chiayi City, , 613

Site Contact

Jen-Tsung Yang, MD/PhD

wkyang@safesavecell.com.tw

+886-5-3621000

Kaohsiung City, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital, Kaohsiung branch

Kaohsiung City, , 833

Site Contact

Jih-Tsun Ho, MD/PhD

wkyang@safesavecell.com.tw

+886-7-7317123

Keelung, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital, Keelung branch

Keelung, , 204

Site Contact

Pin-Yuan Chen, MD/PhD

wkyang@safesavecell.com.tw

+886-2-24313131

Taichung Veterans General Hospital, Taichung City, Taiwan

Status

Recruiting

Address

Taichung Veterans General Hospital

Taichung City, , 407

Site Contact

Chiung-Chyi Shen, MD/PhD

wkyang@safesavecell.com.tw

+886-5-23592525

National Cheng Kung University Hospital, Tainan City, Taiwan

Status

Recruiting

Address

National Cheng Kung University Hospital

Tainan City, , 704

Site Contact

E-Jian Lee, MD/PhD

wkyang@safesavecell.com.tw

+886-6-2353535

Chi Mei Medical Center, Tainan City, Taiwan

Status

Recruiting

Address

Chi Mei Medical Center

Tainan City, , 710

Site Contact

Chin-Hong Chang, MD

wkyang@safesavecell.com.tw

+886-6-2812811

Taoyuan City, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital, Linkou branch

Taoyuan City, , 333

Site Contact

Peng-Wei Hsu, MD

wkyang@safesavecell.com.tw

+886-3-3281200

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