Trial Title:
Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
NCT ID:
NCT05685004
Condition:
Glioblastoma Multiforme of Brain
Conditions: Official terms:
Glioblastoma
Temozolomide
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Blinded over-read of sequential MRI assessments
Intervention:
Intervention type:
Biological
Intervention name:
TVI-Brain-1
Description:
Attenuated autologous cancer cells and activated autologous blood-derived t cells
Arm group label:
Interventional TVI-Brain-1 Autologous Vaccine and activated autologous blood-derived t cells
Intervention type:
Procedure
Intervention name:
Standard of Care
Description:
Surgery for tumor removal or debulking to minimize tumor burden
Arm group label:
Interventional TVI-Brain-1 Autologous Vaccine and activated autologous blood-derived t cells
Arm group label:
Standard of Care
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
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.
Arm group label:
Interventional TVI-Brain-1 Autologous Vaccine and activated autologous blood-derived t cells
Arm group label:
Standard of Care
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
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 .
Arm group label:
Interventional TVI-Brain-1 Autologous Vaccine and activated autologous blood-derived t cells
Arm group label:
Standard of Care
Other name:
Chemotherapy
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.
Detailed 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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Center for Neurosciences
Address:
City:
Tucson
Zip:
85718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Crystal Placencia
Phone:
520-529-5234
Email:
Cplacencia@neurotucson.com
Investigator:
Last name:
Michael Badruddoja, MD
Email:
Principal Investigator
Facility:
Name:
Cedar-Sanai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Yu, MD
Phone:
310-423-7900
Investigator:
Last name:
John Yu, MD
Email:
Principal Investigator
Facility:
Name:
University of Southern California Keck School of Medicine
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Tran, MD
Phone:
323-442-1100
Email:
dtran642@usc.edu
Contact backup:
Last name:
Francis Chow, MD
Phone:
323-442-1100
Email:
chow@usc.edu
Investigator:
Last name:
David Tran, MD
Email:
Principal Investigator
Facility:
Name:
Advent Health
Address:
City:
Orlando
Zip:
32801
Country:
United States
Status:
Withdrawn
Facility:
Name:
Aaron Mammoser
Address:
City:
Atlanta
Zip:
30309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aaron Mammoser, MD
Phone:
404-605-2050
Email:
Aaron.Mammoser@piedmont.org
Contact backup:
Last name:
Andrew Sloan, MD
Phone:
(404)605-2050
Email:
Andrew.Sloan@piedmont.org
Facility:
Name:
University of Kansas Medical Center
Address:
City:
Kansas City
Zip:
66061
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tolga Tuncer, MD
Phone:
913-588-1227
Email:
ttuncer@kumc.edu
Contact backup:
Last name:
Anna Davis
Phone:
913-588-0242
Email:
adavis43@kumc.edu
Investigator:
Last name:
Tolga Tuncer, MD
Email:
Principal Investigator
Facility:
Name:
Capital Health
Address:
City:
Pennington
Zip:
08534
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Salacz, M.D.
Phone:
609-537-5638
Email:
MSalacz@capitalhealth.org
Contact backup:
Last name:
Navid Redjal, M.D.
Phone:
609-537-5638
Email:
Nredjal@capitalhealth.org
Facility:
Name:
Providence St. Vincent
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prakash Ambady, MD
Phone:
503-216-1150
Investigator:
Last name:
Prakash Ambady, MD
Email:
Principal Investigator
Start date:
September 15, 2023
Completion date:
March 2027
Lead sponsor:
Agency:
TVAX Biomedical
Agency class:
Industry
Source:
TVAX Biomedical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05685004
