Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
NCT ID: NCT05685004
Last Updated: 2025-07-01
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2023-09-15
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of Care
Subjects will have standard surgery which will be followed approximately 5 weeks later by combined radiotherapy and chemotherapy consisting of temozolomide 75 mg/m2 dosed once daily beginning on the first day of radiotherapy and continuing until the final day of radiotherapy. Subjects will receive adjuvant temozolomide, and proceed with post therapy surveillance.
Standard of Care
Surgery for tumor removal or debulking to minimize tumor burden
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.
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 .
Interventional TVI-Brain-1 Autologous Vaccine and activated autologous blood-derived t cells
TVI-Brain-1 immunotherapy is integrated with radiation and temozolomide in the test group in the following manner: 1) Subjects undergo surgical resection of their cancer and are tapered off steroids. 2) Subjects receive the first vaccination of TVI-Brain-1 as soon as the laboratory prepared vaccine is available for use (approximately 7 - 14 days following surgery). 3) Subjects receive a second vaccination 7-10 days later. 4) Subjects are leukapheresed to obtain immune T cells for ex vivo-activation. 5) Subjects' T cells are stored frozen until after chemoradiotherapy is completed. 6) Following chemoradiotherapy Subjects are infused with activated effector T cells followed by a 10-day course of low-dose interleukin 2 (IL-2). 7) Subjects then proceed with post therapy surveillance.
TVI-Brain-1
Attenuated autologous cancer cells and activated autologous blood-derived t cells
Standard of Care
Surgery for tumor removal or debulking to minimize tumor burden
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.
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 .
Interventions
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TVI-Brain-1
Attenuated autologous cancer cells and activated autologous blood-derived t cells
Standard of Care
Surgery for tumor removal or debulking to minimize tumor burden
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.
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 .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines
* The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department
* Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits
* not currently receiving glucocorticoids and have been off glucocorticoids for at least 24 hours prior to vaccination as well as when they receive the T cell infusion.
* Patient function assessment (Karnofsky score is \> 60)
* a life expectancy of \> 12 weeks.
* Hemoglobin is \> 10 g/dL (may be transfused)
* White blood cell count is \> 3,000 cells/microliter (mcL) of blood.
* Platelet count is \> 100,000 platelets per mcL of blood (transfusion independent)
* Lymphocyte count is \> 1,000 cells/mcL of blood.
Exclusion Criteria
* a second malignancy that is not in remission as determined by the clinical investigator. Exception: squamous or basal cell carcinoma of the skin.
* requirement for treatment with glucocorticoids to control brain swelling
* presence of active autoimmune disease that is currently being actively treated.
* psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
* Current pregnancy or a plan to become pregnant within 1-year following the study.
18 Years
80 Years
ALL
No
Sponsors
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TVAX Biomedical
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Aguiar, APRN
Role: STUDY_DIRECTOR
TVAX Biomedical, Inc
Locations
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Center for Neurosciences
Tucson, Arizona, United States
Cedar-Sanai Medical Center
Los Angeles, California, United States
University of Southern California Keck School of Medicine
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Aaron Mammoser
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Capital Health
Pennington, New Jersey, United States
Providence St. Vincent
Portland, Oregon, United States
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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TVI-AST-008
Identifier Type: -
Identifier Source: org_study_id
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