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Cancer Vaccine

Dendritic Cell Vaccine for Glioblastoma

Phase 1
Waitlist Available
Led By Ashley Ghiaseddin, MD
Research Sponsored by University of Florida
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 leukapheresis to investigational product release date or up to 6 weeks
Awards & highlights

Study Summary

This trial is looking at whether it's possible to generate an investigational vaccine for patients with brain cancer who have already started chemotherapy.

Who is the study for?
Adults over 18 with newly diagnosed Glioblastoma who've finished radiation and are on Temozolomide therapy can join. They need a Karnofsky score of at least 70, stable steroid doses, good organ function, and no severe illnesses or prior invasive cancers (except skin cancer) in the last 3 years. Women must not be pregnant and participants must use contraception.Check my eligibility
What is being tested?
The trial is testing a personalized vaccine made from patients' own immune cells loaded with CMV RNA to treat Glioblastoma. It's for those who have completed initial treatment and are now on maintenance chemotherapy.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation, flu-like symptoms due to GM-CSF, fatigue, injection site reactions, and potential complications from drawing blood to make the vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~leukapheresis to investigational product release date or up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and leukapheresis to investigational product release date or up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to generate CMV pp65 RNA-pulsed DCs in patients receiving adjuvant temozolomide chemotherapy after radiotherapy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous DCs derived from PBMC loaded with RNAExperimental Treatment1 Intervention
Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,699 Total Patients Enrolled
10 Trials studying Glioblastoma
477 Patients Enrolled for Glioblastoma
Immunomic Therapeutics, Inc.Industry Sponsor
8 Previous Clinical Trials
470 Total Patients Enrolled
2 Trials studying Glioblastoma
185 Patients Enrolled for Glioblastoma
Ashley Ghiaseddin, MDPrincipal InvestigatorUniversity of Florida
3 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Glioblastoma
58 Patients Enrolled for Glioblastoma

Media Library

Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04963413 — Phase 1
Glioblastoma Research Study Groups: Autologous DCs derived from PBMC loaded with RNA
Glioblastoma Clinical Trial 2023: Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF Highlights & Side Effects. Trial Name: NCT04963413 — Phase 1
Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963413 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible to enroll in this experiment at the present moment?

"Affirmative. According to the information provided on clinicaltrials.gov, this clinical trial is currently seeking participants and was launched in January 13th 2022 with a recent update posted on April 29th of the same year. A total of 10 subjects need to be enrolled at 1 medical centre."

Answered by AI

Who is eligible to enroll in this research endeavor?

"To be eligible for this trial, participants must have glioblastoma and within the ages of 18 to 90. The study is currently recruiting a maximum of 10 patients."

Answered by AI

How many participants has this trial recruited thus far?

"Affirmative. Clinicaltrials.gov reports that this medical trial, initially published on January 13th 2022, is presently recruiting patients. 10 subjects are needed from a single healthcare centre for the study to be completed successfully."

Answered by AI

Has the FDA sanctioned Autologous DCs which are sourced from PBMC and loaded with RNA coding for human CMV matrix protein pp65-flLAMP alongside GM-CSF?

"The safety of Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF is only assumed to be minimal due to its being a Phase 1 trial and there being limited data available on both efficacy and safety."

Answered by AI

Is this research endeavor accepting participants aged 25 or older?

"According to the requirements for admission, participants must be between 18 and 90 years old in order to take part."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.
2022. "RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04963413.
~2 spots leftby Apr 2025
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