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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04277221
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Safe Save Medical Cell Sciences & Technology Co.,Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Biological: Autologous Dendritic Cell/Tumor Antigen, ADCTA Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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.

Active Comparator: Standard therapy (control group)
  • No study treatment
  • Bevacizumab as standard therapy
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.




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 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) [ Time Frame: The duration will be calculated from the date of randomization to the date of the sixth month. ]
  3. 1 and 2-year Survival Rate [ Time Frame: The duration will be calculated from the date of randomization to the date of the first year and the second year. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277221


Contacts
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Contact: Wen-Kuang Yang, PhD +886-3-5506696 wkyang@safesavecell.com.tw
Contact: Weber Liu, MS +886-3-5506696 wbliu@safesavecell.com.tw

Locations
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Taiwan
Chang Gung Memorial Hospital, Chiayi branch Recruiting
Chiayi City, Taiwan, 613
Contact: Jen-Tsung Yang, MD/PhD    +886-5-3621000      
Principal Investigator: Jen-Tsung Yang, MD/PhD         
Chang Gung Memorial Hospital, Kaohsiung branch Recruiting
Kaohsiung City, Taiwan, 833
Contact: Jih-Tsun Ho, MD/PhD    +886-7-7317123      
Principal Investigator: Jih-Tsun Ho, MD/PhD         
Chang Gung Memorial Hospital, Keelung branch Recruiting
Keelung, Taiwan, 204
Contact: Pin-Yuan Chen, MD/PhD    +886-2-24313131      
Principal Investigator: Pin-Yuan Chen, MD/PhD         
Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 407
Contact: Chiung-Chyi Shen, MD/PhD    +886-5-23592525      
Principal Investigator: Chiung-Chyi Shen, MD/PhD         
Sub-Investigator: Wen-Yu Cheng, MD/PhD         
National Cheng Kung University Hospital Recruiting
Tainan City, Taiwan, 704
Contact: E-Jian Lee, MD/PhD    +886-6-2353535      
Principal Investigator: E-Jian Lee, MD/PhD         
Sub-Investigator: Tsai-Yun Chen, MD         
Sub-Investigator: Chia-Jui Yen, MD/PhD         
Chi Mei Medical Center Recruiting
Tainan City, Taiwan, 710
Contact: Chin-Hong Chang, MD    +886-6-2812811      
Principal Investigator: Chin-Hong Chang, MD         
Sub-Investigator: Yin-Hsun Feng, MD/PhD         
Chang Gung Memorial Hospital, Linkou branch Recruiting
Taoyuan City, Taiwan, 333
Contact: Peng-Wei Hsu, MD    +886-3-3281200      
Principal Investigator: Peng-Wei Hsu, MD         
Sub-Investigator: Kuo-Chen Wei, MD         
Sub-Investigator: Ying-Cheng Huang, MD/PhD         
Sub-Investigator: Pin-Yuan Chen, MD/PhD         
Sub-Investigator: Chi-Cheng Chuang, MD         
Sub-Investigator: Hong-Chieh Tsai, MD         
Sub-Investigator: Cheng-Chi Lee, MD/PhD         
Sub-Investigator: Ko-Ting Chen, MD         
Sub-Investigator: Chi-Ting Liau, MD         
Sub-Investigator: Cheng-Hong Toh, MD/PhD         
Sponsors and Collaborators
Safe Save Medical Cell Sciences & Technology Co.,Ltd.
Investigators
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Principal Investigator: Peng-Wei Hsu, MD Chang Gung Memorial Hospital
Publications of Results:
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Responsible Party: Safe Save Medical Cell Sciences & Technology Co.,Ltd.
ClinicalTrials.gov Identifier: NCT04277221    
Other Study ID Numbers: ADCTA-SSI-G1
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Safe Save Medical Cell Sciences & Technology Co.,Ltd.:
Recurrent Glioblastoma Multiforme
Immunotherapy
Dendritic Cell
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue