Clinical Trials

Focusing on the patient

Glioblastoma Multiforme (GBM)

GBM has a devastating outcome. Where the median 5-year survival is around 5%, long-term responses are rare. The medical need for these patients is very high and improvements to the standard of care are critical. While anti-PD-1/PD-L1 checkpoint inhibitors have had striking success in other indications, GBM generally remains resistant to this approach. Additional study is needed to confirm any additional benefits.

Unfortunately, response rates to the checkpoint blockade in the treatment of GBM are very poor. About 5% of patients respond to this approach when used as a monotherapy.

Dr. John Sampson, M.D., Ph.D.

Watch Dr. Sampson discuss the promise of cancer immunotherapy and the challenge of this approach in brain cancer.

GBM and CMV

Cytomegalovirus (CMV), a common virus which infects over 50% of adults by the age of 40, and Glioblastoma Multiforme (GBM) are purported to be associated. Although there is some debate with regard to both the presence and role that CMV plays in GBM, there are publications which support the association:

As a result, Drs. Sampson and Mitchell developed approaches which capitalize on this association:

Dr. Duane Mitchell, M.D., Ph.D.

Watch Dr. Mitchell talk about the relationship between CMV and GBM, and the ATTAC-II clinical trial.

Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (ATTAC-II)

The vaccine used in this clinical trial leverages ITI’s investigational lysosomal targeting technology in the context of cell therapy.  The patients’ dendritic cells are removed, vaccinated in the trial’s experimental study arms against a structural protein of a cytomegalovirus, purported to correlate with the incidence of GBM, then returned to the patient.

General Protocol

  • Autologous dendritic cell (DC) vaccine loading with pp65-LAMP
  • mRNA electroporation into DCs
  • Administered after completion of standard of care consisting of maximal resection, followed by one round or concurrent radiotherapy and temozolomide
  • The vaccine is administered at the completion of each subsequent round of RT and TMZ for up to ten doses

Official Title:
A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma

Summary:
The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.

Description:
Dendritic cells (DC) are involved in activating, or turning-on, your body’s immune system. Your immune system helps guard your body from germs, viruses, and other threats. Although dendritic cells are very strong, the number of them in the body is not high enough to cause a powerful immune response; therefore, more DC are made in a laboratory with cells collected from an individual’s blood.

In this study, we will make a vaccine that we hope will educate immune cells to target the pp65 antigen, a type of immune marker in GBM, thus resulting in what we call the pp65 DC vaccine. Use of a vaccine that activates your immune system is a type of immunotherapy. It is hoped that by giving the pp65 DC vaccine as a shot under the skin, the immune system will be activated to attack tumor cells in the brain while leaving normal cells alone.

To see if the pp65 DC vaccine is effective for the treatment of GBM, subjects will be assigned to different treatment groups. Two groups of subjects will receive the pp65 DC vaccine and one group will receive a placebo (note that placebo means temozolomide chemotherapy, without the DC therapy).

ClinicalTrials.gov Identifier: NCT02465268

More information about this trial can be found here.

The Patient at the Center

Immunomic Therapeutics is a biotech company committed to patients. We are a patient advocacy company that understands that patient enrollment in clinical trials is critical to advancements in medicine and patient treatment. To demonstrate our dedication to patients and our understanding of the importance of clinical trials, we have created a patient travel fund in support of patients who meet the ATTAC-II clinical trial enrollment criteria, enroll in the trial, and live more than 100 miles away from a trial site.

Dr. Bill Hearl, Ph.D.

Watch Dr. Hearl talk about the Immunomic Therapeutics travel fund and the company’s focus on patient advocacy.

Patient Resources

The patient resources section is intended to provide a list of brain tumor organizations and other information sources dedicated to brain tumor education, research and support.