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TVI-Brain-1 in Expanded Access Patient | Clinical Trials | Clareo Health

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No Longer AvailableNCT05936216

TVI-Brain-1 in Expanded Access Patient

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 t...

Lead sponsor: TVAX Biomedical•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

TVAX Biomedical

The TVI-Brain-1 treatment involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated with the vaccine formulation. Third, the patient's blood will be filtered for killer T cell precursors which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated cells will be infused into the patient's bloodstream so that they will be able to attack the cancer.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 1, 2024Terms

Trial snapshot

StatusNO_LONGER_AVAILABLE

Phase—

Enrollment—

Start date—

Last updatedOct 1, 2024

Condition

Recurrent Glioblastoma

Locations shown

Providence St. Vincent Medical Center

Portland, Oregon

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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