Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma

NCT03400917 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: CL-GBM-P01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

Brief Summary

This is a single-arm, open-label phase II clinical trial in which approximately 55 patients with newly diagnosed glioblastoma (GBM) will be enrolled with the intent to receive an autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1).

Conditions

Newly Diagnosed Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint: Overall Survival

  Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1

  3 years

Study Arms (1)

AV-GBM-1

EXPERIMENTAL

Autologous dendritic cells loaded with tumor associated antigens from a short-term cell culture of autologous tumor cells. AV-GBM-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.

Biological: AV-GBM-1

Interventions

AV-GBM-1 BIOLOGICAL

Investigational treatment with AV-GBM-1

AV-GBM-1

Eligibility Criteria

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

You may qualify if:

• Karnofsky Performance Score of 70-100%
• Histology confirmed to be GBM (Grade IV WHO, glioblastoma, gliosarcoma)
• Successful establishment of an autologous cancer cell line by AIVITA Biomedical, Inc.
• Collection of a satisfactory leukapheresis product
• About to begin concurrent CT/RT
• Given written informed consent to participate in the study

You may not qualify if:

• Known to have active hepatitis B or C or HIV
• Karnofsky Performance Score of \< 70%
• Known underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
• Diagnosis of any other invasive cancer or other disease process which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than GBM
• Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
• Known autoimmune disease, immunodeficiency, or disease process that involves the chronic use of immunosuppressive therapy.
• Received another investigational drug within 28 days of the first dose or are planning to receive another investigational drug while receiving this investigational treatment.
• Known hypersensitivity to GM-CSF
• Pregnancy

Sponsors & Collaborators

• Aivita Biomedical, Inc.: lead

Study Sites (8)

Scripps Health

La Jolla, California, 92037, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92037, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Rutgers Cancer Institute

New Brunswick, New Jersey, 08903, United States

Location

Related Publications (1)

• Bota DA, Taylor TH, Piccioni DE, Duma CM, LaRocca RV, Kesari S, Carrillo JA, Abedi M, Aiken RD, Hsu FPK, Kong XT, Hsieh C, Bota PG, Nistor GI, Keirstead HS, Dillman RO. Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment. J Exp Clin Cancer Res. 2022 Dec 14;41(1):344. doi: 10.1186/s13046-022-02552-6.

  PMID: 36517865 DERIVED

Study Officials

• Robert O Dillman, MD

  Aivita Biomedical, Inc.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: June 20, 2018
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2023
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

US (8)