Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients

NCT04115761 | Recruiting Phase 2 DMC

• 1 other identifier: ES-CDCV01-A2201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

GBM

Outcome Measures

Primary Outcomes (1)

• 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.

  the percentage of patients surviving 1 year after randomization without objective tumor progression or death.

Study Arms (2)

Investigational Group

OTHER

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

Control Group

OTHER

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

Interventions

autologous dendritic cells BIOLOGICAL

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.

Control Group; Investigational Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage I (Pre-screening)
• Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery.
• Patients with newly diagnosed single, primary, WHO grade IV, glioblastoma (except for locating on brainstem or cerebellum) scheduled to undergo craniotomy tumor excision, and are willing to preserve the resected tumor cells enabling the production of ADCV01.
• Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer).
• Only one GBM tumor number.
• Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study.
• Patients have the expected life expectancy of \> 12 weeks at the pre-screening visit as judged by the investigator.
• Patients with stable vital sign and KPS ≥ 70 at the pre-screening visit.
• Patients with adequate renal function at the pre-screening visit:
• serum creatinine \< 1.8 mg/dL; creatinine clearance \> 30 mL/min
• Patients with adequate liver function at the pre-screening visit:
• AST, ALT, and ALP ≤ 3× upper limit of normal (ULN); and total bilirubin \< 3 mg/dL
• Patients with prothrombin time and activated partial thromboplastin time ≤ 1.5× ULN at the pre-screening visit
• Patients with adequate hematopoietic function at the prescreening and before administration of study medication
• Absolute neutrophil count (ANC) ≥ 1,000 cells/μL

You may not qualify if:

• Stage I (Pre-screening)
• Number of GBM is more than one
• Patient who has participated in other investigational studies within 4 weeks prior to pre-screening
• Patient with known or suspected hypersensitivity to ADCV01 or its excipients
• Patient who has a history of hypersensitivity reaction (e.g., urticarial, allergic reaction including anaphylaxis, toxic epidermal necrosis, and Stevens-Johnson syndrome) to dacarbazine (DTIC) or any components of medications of temozolomide and bevacizumab
• Patient has acute infectious disease or acute cardiovascular disease; clinically manifest myocardial insufficiency or history of myocardial infarction during the past 6 months prior to prescreening; or has active uncontrolled arterial hypertension as supported by medical history.
• Patient has clinically significant immuno-compromised condition (other than that related to the use of corticosteroids), is human immunodeficiency virus positive (anti-HIV and nucleic acid test) or medical condition requiring systemic immunesuppressive treatments.
• Patient with active rheumatic disease or other collagen vascular disease, or is with active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barre syndrome). Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition, only requiring hormone replacement therapy are permitted to enroll.
• Patients with psoriasis requiring systemic therapy, or conditions expected to recur in the presence of an external trigger
• Patient with syphilis, acute HBV, HCV (except hepatitis carriers), HTLV-I/II, CMV, or an increased risk (or has been diagnosed) for human transmissible spongiform encephalopathy (TSE); including Creutzfeldt-Jakob disease (CJD)
• Patient with history of coagulation disorder associated with bleeding or recurrent thrombotic events
• Patient with medical, social, or psychological factors interfering with compliance of the study
• Female patient who is lactating, pregnant, or planned to be pregnant
• Inability to undergo MRI for any reason
• History of malignancy other than glioma that is not stable in the past 5 years prior to pre-screening (informed consent form signing date)

Sponsors & Collaborators

• Ever Supreme Bio Technology Co., Ltd.: lead

Study Sites (3)

Taichung Veterans General Hospital

Taichung, Non-US, 407, Taiwan

RECRUITING

Chang-Gung Memorial Hospital at Lin-Ko

Taoyuan District, Non-US, 333, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Related Publications (3)

• Jan CI, Tsai WC, Harn HJ, Shyu WC, Liu MC, Lu HM, Chiu SC, Cho DY. Predictors of Response to Autologous Dendritic Cell Therapy in Glioblastoma Multiforme. Front Immunol. 2018 May 29;9:727. doi: 10.3389/fimmu.2018.00727. eCollection 2018.

  PMID: 29910795 BACKGROUND

• Han K, Ren M, Wick W, Abrey L, Das A, Jin J, Reardon DA. Progression-free survival as a surrogate endpoint for overall survival in glioblastoma: a literature-based meta-analysis from 91 trials. Neuro Oncol. 2014 May;16(5):696-706. doi: 10.1093/neuonc/not236. Epub 2013 Dec 12.

  PMID: 24335699 BACKGROUND

• Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

  PMID: 15758009 BACKGROUND

Study Officials

• Wen-Liang Huang

  Ever-Supreme Biotechnology

  STUDY DIRECTOR

Central Study Contacts

Wen-Liang Huang

CONTACT

0422052121; wlhuang@ever-supreme.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: June 6, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)