Study on Dendritic Cell Immunotherapy for Treating Adult Glioblastoma

Sponsor: Diakonos Oncology Corporation

Sponsor score: 0

ClinicalTrials ID:NCT06805305

This clinical trial is testing a new treatment that combines DOC1021 and pIFN with standard care to see if it can help adults with newly diagnosed glioblastoma live longer. The study will also check the safety of this new treatment approach.

Patient Parameters

Program Overview

The aim of this study is to find out if adding DOC1021 dendritic cell immunotherapy and pIFN to the usual treatment can improve survival in adults with newly diagnosed glioblastoma, a type of brain cancer. Participants will be divided into two groups: one will receive the new treatment along with standard care, and the other will receive standard care alone. The new treatment involves taking a medication called filgrastim, undergoing a procedure to collect white blood cells, and receiving injections of DOC1021 and pIFN. All participants will have regular clinic visits to monitor their health and receive standard treatments like surgery, chemotherapy, and radiation.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a new diagnosis of glioblastoma that can potentially be removed by surgery and be a good candidate for standard postoperative treatments like temozolomide and radiation.
  • Must be able to receive the study treatments, including filgrastim, leukapheresis, and injections of DOC1021 and pIFN.
  • Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study.
  • Must have good kidney, liver, bone marrow, and immune function, as shown by specific blood test results.
  • Must have a Karnofsky Performance Score of 70 or higher, indicating the ability to care for oneself and carry out normal activities.

Exclusion Criteria

  • Cannot have certain types of brain cancer, such as multifocal, deep midline, or recurrent disease.
  • Cannot be pregnant or breastfeeding.
  • Cannot have active HIV or hepatitis infections, unless well-controlled.
  • Cannot have severe or uncontrolled medical conditions that could affect participation, such as severe heart disease or autoimmune disorders requiring recent treatment.
  • Cannot have taken another experimental drug or treatment within the last 30 days.

Locations

FACILITYZIPCITYSTATE
City of Hope91010DuarteCalifornia

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