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

• ClinicalTrials.gov Identifier: NCT03400917
• Recruitment Status: Active, not recruiting
• First Posted: January 17, 2018
• Last Update Posted: December 16, 2021
• Sponsor: Aivita Biomedical, Inc.
• Information provided by (Responsible Party): Aivita Biomedical, Inc.

Tracking Information

• First Submitted Date: January 10, 2018
• First Posted Date: January 17, 2018
• Last Update Posted Date: December 16, 2021
• Actual Study Start Date: June 20, 2018
• Actual Primary Completion Date: December 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2018)

Primary Efficacy Endpoint: Overall Survival [ Time Frame: 3 years ]

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma
• Official Title: Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma
• 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).

Detailed Description

This is a single-arm, open-label phase II clinical trial in which approximately 55 patients will be enrolled with the intent to receive AV-GBM-1. Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

The primary endpoint of this trial is overall survival (OS), death from any cause measured from the date of study enrollment for treatment with AV-GBM-1. Secondary endpoints will include (1) PFS measured from date of enrollment, (2) OS/PFS measured from date of diagnosis and (3) OS/PFS from date of enrollment based on KPS, age, and extent of surgical resection. Tertiary endpoints will include (1) OS/PFS from date of first injection and (2) OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.

Patient Population: Patients 18 years or older with newly diagnosed glioblastoma [World Health Organization (WHO) Grade IV glioma, Grade IV anaplastic astrocytoma, glioblastoma or gliosarcoma, glioblastoma multiforme (GBM)] who have recovered from surgery, for whom an autologous tumor cell culture and leukapheresis product are available, who have a KPS of > 70, and who are about to begin concurrent CT/RT.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Newly Diagnosed Glioblastoma

Intervention

Biological: AV-GBM-1

Investigational treatment with AV-GBM-1

Study Arms

Experimental: AV-GBM-1

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.

Intervention: Biological: AV-GBM-1

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 10, 2018): 55
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2023
• Actual Primary Completion Date: December 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03400917
• Other Study ID Numbers: CL-GBM-P01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Aivita Biomedical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Aivita Biomedical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Robert O Dillman, MD; Aivita Biomedical, Inc.

• PRS Account: Aivita Biomedical, Inc.
• Verification Date: December 2021