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

NCT04277221 | Unknown Phase 3 DMC

• 1 other identifier: ADCTA-SSI-G1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 7

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.

Conditions

Glioblastoma Multiforme

Keywords

Recurrent Glioblastoma Multiforme; Immunotherapy; Dendritic Cell

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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)

• Progression-free Survival (PFS)

  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.

• Progression-free Survival at 6 months (PFS6)

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

• 1 and 2-year Survival Rate

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

Study Arms (2)

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

Biological: Autologous Dendritic Cell/Tumor Antigen, ADCTA

Standard therapy (control group)

ACTIVE COMPARATOR

* No study treatment * Bevacizumab as standard therapy

Biological: Autologous Dendritic Cell/Tumor Antigen, ADCTA

Interventions

Autologous Dendritic Cell/Tumor Antigen, ADCTA BIOLOGICAL

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.

Standard therapy (control group); Standard therapy with ADCTA vaccine (study group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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;

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Safe Save Medical Cell Sciences & Technology Co.,Ltd.: lead

Study Sites (7)

Chang Gung Memorial Hospital, Chiayi branch

Chiayi City, 613, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Kaohsiung branch

Kaohsiung City, 833, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Keelung branch

Keelung, 204, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, 710, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Linkou branch

Taoyuan, 333, Taiwan

RECRUITING

Related Publications (2)

• 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.

  PMID: 21715171 RESULT

• 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.

  PMID: 32691060 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Peng-Wei Hsu, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Kuang Yang, PhD

CONTACT

+886-3-5506696; wkyang@safesavecell.com.tw

Weber Liu, MS

CONTACT

+886-3-5506696; wbliu@safesavecell.com.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 20, 2020
• Study Start: September 19, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7)