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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05685004
Other study ID # TVI-AST-008
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 15, 2023
Est. completion date March 2026

Study information

Verified date April 2024
Source TVAX Biomedical
Contact Jean Aguiar
Phone 1 913 492 2221
Email info@tvaxbiomedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.


Description:

This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The general procedures include the collection and testing of cancer tissue samples after surgery and chemoradiation therapy (radiation and temozolomide). For the patients randomized into the investigational study treatment group, they will also receive two vaccinations created from their own cancer cells, undergo leukapheresis to collect immune T-cells from their blood, and transfer of those activated effector T-cells after chemoradiation therapy. All patients are followed with MRIs at follow-up visits.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
TVI-Brain-1
Attenuated autologous cancer cells and activated autologous blood-derived t cells
Procedure:
Standard of Care
Surgery for tumor removal or debulking to minimize tumor burden
Radiation:
Radiotherapy
Conformal radiotherapy consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks.
Drug:
Temozolomide
All Subjects receive 75 mg/m2 of temozolomide daily beginning on the first day of radiotherapy and continuing until the completion of radiotherapy. Standard of care Subjects will also receive adjuvant temozolomide .

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas
United States Cedar-Sanai Medical Center Los Angeles California
United States University of Southern California Keck School of Medicine Los Angeles California
United States Capital Health Newark New Jersey
United States Advent Health Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
TVAX Biomedical

Country where clinical trial is conducted

United States, 

References & Publications (5)

Holladay FP, Heitz T, Chen YL, Chiga M, Wood GW. Successful treatment of a malignant rat glioma with cytotoxic T lymphocytes. Neurosurgery. 1992 Sep;31(3):528-33. doi: 10.1227/00006123-199209000-00015. — View Citation

Holladay FP, Heitz T, Wood GW. Antitumor activity against established intracerebral gliomas exhibited by cytotoxic T lymphocytes, but not by lymphokine-activated killer cells. J Neurosurg. 1992 Nov;77(5):757-62. doi: 10.3171/jns.1992.77.5.0757. — View Citation

Plautz GE, Touhalisky JE, Shu S. Treatment of murine gliomas by adoptive transfer of ex vivo activated tumor-draining lymph node cells. Cell Immunol. 1997 Jun 15;178(2):101-7. doi: 10.1006/cimm.1997.1140. — View Citation

Sloan 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. — View Citation

Wood GW, Turner T, Wang YY, Holladay FP. Immune rejection of intracerebral gliomas using lymphocytes from glioma-bearing rats. J Immunother. 1999 Nov;22(6):497-505. doi: 10.1097/00002371-199911000-00004. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Assessment of changes in patient through Physical Examination Through study completion, an average of 2 years
Other Immunogenicity Delayed-type hypersensitivity (DTH) skin testing using attenuated autologous cancer cells will be performed to assess the immunogenicity of the Subject's cancer. Assessed at 24 hours after each vaccine administration
Other Other genetic and immunologic parameters The study is also designed to determine whether a wide variety of genetic and immunologic parameters that are monitored during and following treatment correlate with clinical outcomes Assessed at 24 hours after each vaccine administration
Primary Survival All Subjects will be evaluated and contacted to evaluate their status From date of randomization until the date of death from any cause assessed up to 24 months after randomization.
Secondary Progression-free survival Time to progression is evaluated by review and analysis of serial MRI's taken at specific Time to progression is evaluated by review and analysis of serial MRI's taken at specific timepoints From date of randomization until the date of first documented progression assessed up to 24 months after randomization
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