← Back to Search

Personalized Immunotherapy for Glioblastoma

Phase 2 & 3

Recruiting

Led By Michael Salacz, MD

Research Sponsored by TVAX Biomedical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study an immunotherapy combining a cancer-patient's own cells and standard treatment to fight glioblastoma. Immune cells will be harvested from the patient, stimulated and expanded, then infused back.

Who is the study for?

This trial is for adults with newly diagnosed MGMT unmethylated glioblastoma who haven't been treated before. They need enough tumor tissue from surgery to make a vaccine, normal kidney and liver function, no current steroid use, good physical function (Karnofsky score > 60), expected to live more than 12 weeks, and specific blood cell counts within the required range. Pregnant individuals or those planning pregnancy within a year are excluded.

What is being tested?

The study tests TVI-Brain-1 immunotherapy combined with standard care versus standard care alone in treating glioblastoma. It involves creating a personalized vaccine from the patient's cancer cells to boost immune response and infusing expanded T cells back into the patient.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, skin reactions at injection sites; complications from T cell infusion like chills or shortness of breath; and typical chemotherapy/radiotherapy side effects like nausea or hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survival

Secondary study objectives

Progression-free survival

Other study objectives

Immunogenicity

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Other genetic and immunologic parameters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional TVI-Brain-1 Autologous Vaccine and activated autologous blood-derived t cellsExperimental Treatment4 Interventions

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.

Group II: Standard of CareActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TVI-Brain-1

2011

Completed Phase 2

~20

Standard of Care

2017

Completed Phase 4

~4420