RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.

NCT04963413 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: IRB202002778OCR39689
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

In prior trials of CMV RNA-pulsed dendritic cell vaccines, there has been a narrow window between surgery and initiation of chemoradiation to enroll patients and perform leukapheresis (to obtain cells needed to generate investigational vaccine). Patients who had started chemoradiation were not eligible to participate. In this study, the investigators propose to conduct a pilot study to evaluate the ability to generate pp65 full-length LAMP RNA-pulsed DCs in patients who have completed standard external beam radiation and concomitant temozolomide who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.

Conditions

Glioblastoma

Keywords

Immunotherapy; Vaccine Therapy; Immune system; Dendritic Cell; High grade brain tumor

Outcome Measures

Primary Outcomes (1)

• Ability to generate CMV pp65 RNA-pulsed DCs in patients receiving adjuvant temozolomide chemotherapy after radiotherapy.

  Proportion of patients who are able to generate at least 3 CMV pp65 RNA-pulsed DCs vaccines

  Leukapheresis to investigational product release date or up to 6 weeks

Study Arms (1)

Autologous DCs derived from PBMC loaded with RNA

EXPERIMENTAL

Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF

Biological: Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF

Interventions

Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF BIOLOGICAL

Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF

Autologous DCs derived from PBMC loaded with RNA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Confirmed diagnosis of de novo Glioblastoma (WHO Grade IV glioma) by histopathology or molecular studies. (Secondary GBM not eligible).
• The tumor must have a supratentorial component.
• Patient have completed standard external beam radiation with concomitant temozolomide.
• (Minimum dose for concomitant radiotherapy is 40 Gy)
• Patient must be receiving adjuvant therapy with Temozolomide at time of enrollment.
• Karnofsky Performance Status (KPS) ≥ 70.
• Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the legally authorized representative.
• For females of childbearing potential, negative serum pregnancy test at enrollment.
• Women of childbearing potential (WOCBP) must be willing to use acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
• Refer to Appendix B for definition of WOCBP and guidance on acceptable contraceptive methods.
• Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.
• Refer to Appendix B for guidance on acceptable contraceptive methods.
• For patients receiving steroids, daily dose must be \< 4 mg.
• Adequate Bone marrow and organ function as defined below:

You may not qualify if:

• Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
• Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
• Recurrent disease
• Multifocal gliomas defined as distinct tumors that do not have overlapping T2/FLAIR signal.
• HIV, Hepatitis B, or Hepatitis C seropositive.
• Known active infection (requiring treatment by antiviral or antibiotic) at time of enrollment
• Immunosuppressive disease.
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization.
• Transmural myocardial infarction within the last 6 months.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
• Patients with autoimmune disease requiring medical management with systemic immunosuppressants.
• Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.

Sponsors & Collaborators

• University of Florida: lead
• Immunomic Therapeutics, Inc.: collaborator

Study Sites (1)

University of Florida Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ashley Ghiaseddin, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 15, 2021
• Study Start: January 13, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)