Clinical trial · Expanded Access
TVI-Brain-1 in Expanded Access Patient
Expanded Access Use Of Tvi-Brain-1 For Treatment Of Recurrent Grade 4 Astrocytoma (Glioblastoma Multiforme; GBM)
- 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)
TVI-Brain-1 is being offered as a potential treatment option to a Named Patient (Emergency Use Authorization IND) for recurrent glioblastoma as there is no effective systemic treatment available for this disease or patient. TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.
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 |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TVI-Brain 1 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Recurrent glioblastoma diagnosis confirmed * Age \> 18 * Informed consent * Diagnosis of grade IV glioma with progression following standard treatment. * Must be able to tolerate surgery to provide tumor tissue for vaccine. * Must be able to produce viable vaccine from tumor tissue. * Karnofsky Performance Status must be 70 or greater. * Negative HIV test. * Negative for hepatitis B and C virus. * Respiratory reserve must be reasonable. * Sufficient renal function. * Satisfactory blood counts. * Negative pregnancy test for women of childbearing potential. Exclusion Criteria: * Surgically removed cancer reveals that it is not grade IV glioma. * Concomitant life-threatening disease. * Active autoimmune disease. * Currently receiving chemotherapy or biological therapy for the treatment of cancer. * Currently receiving immunosuppressive drugs for any reason. * Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months. * Prior treatment with Gliadel wafers. * Corticosteroids beyond peri-operative period. * Psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
References
Publications (2)
- BACKGROUNDSloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9. doi: 10.3171/foc.2000.9.6.10. PMID 16817692
- BACKGROUNDRosenberg SA, Packard BS, Aebersold PM, Solomon D, Topalian SL, Toy ST, Simon P, Lotze MT, Yang JC, Seipp CA, et al. Use of tumor-infiltrating lymphocytes and interleukin-2 in the immunotherapy of patients with metastatic melanoma. A preliminary report. N Engl J Med. 1988 Dec 22;319(25):1676-80. doi: 10.1056/NEJM198812223192527. PMID 3264384