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Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment) - 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:

  • - another concomitant life-threatening disease (not including glioblastoma multiforme) - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05685004
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 TVAX Biomedical
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jean Aguiar, APRN
Principal Investigator Affiliation TVAX Biomedical, Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme of Brain
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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.

Experimental: 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.

Interventions

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 .

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedar-Sanai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedar-Sanai Medical Center

Los Angeles, California, 90048

Site Contact

John Yu, MD

info@tvaxbiomedical.com

310-423-7900

Los Angeles, California

Status

Recruiting

Address

University of Southern California Keck School of Medicine

Los Angeles, California, 90048

Site Contact

Francis Chow, MD

chow@usc.edu

323-442-1100

Advent Health, Orlando, Florida

Status

Recruiting

Address

Advent Health

Orlando, Florida, 32801

Site Contact

Sherif Makar, MD

info@tvaxbiomedical.com

407-303-2770

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66061

Site Contact

Tolga Tuncer, MD

ttuncer@kumc.edu

913-588-1227

Capital Health, Newark, New Jersey

Status

Recruiting

Address

Capital Health

Newark, New Jersey, 08638

Site Contact

Michael Salacz, M.D.

MSalacz@capitalhealth.org

609-394-6000

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