Clinical trial · Interventional
Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AV-GBM-1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AV-GBM-1
- description
- 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.
- interventionNames
- Biological: AV-GBM-1
Primary outcomes (1)
- measure
- Primary Efficacy Endpoint: Overall Survival
- timeFrame
- 3 years
- description
- Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBota 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