Trials Today

Dendritic Cell Immunotherapy for Treatment of Adult GBM

Purpose

The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone. Participants in the DOC1021 + pIFN + SOC arm will: - Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection - Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses - Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections Both arms of the trial will: - Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation

Condition

Glioblastoma (GBM)

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age 18 years or older 4. Presumed diagnosis of GBM deemed to be potentially resectable and deemed to be a good candidate for postoperative standard of care temozolomide and radiation therapy. 1. The surgical objective is for gross total resection (GTR)/near-total resection (NTR) defined as greater than or equal to 95% of contrast enhancing (CE) tumor removed plus less than or equal to 1 cm3 residual CE tumor. Patients with subtotal resection will still be eligible if at least 70% of the CE tumor is resected. 2. Eligibility will be confirmed after surgery when diagnosis of GBM IDH-wt confirmed prior to randomization. 3. Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated. 5. Ability to receive filgrastim (e.g. Neupogen), leukapheresis and 3 bi-weekly injections of DOC1021 near deep cervical lymph nodes + weekly pIFN x 6 weeks. 6. Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as determined appropriate for the patient by the investigator) during study treatment. 7. Adequate kidney, liver, bone marrow function, and immune function, as follows: 1. Hemoglobin ≥ 8.0 gm/dL (use of transfusion or other intervention to achieve is acceptable) 2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 3. Platelet count ≥ 75,000/mm3 4. Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gault formula: i. For males = (140 - age[years]) x (body weight [kg]) / (72 x serum creatinine [mg/dL]) ii. For females = 0.85 x value from male formula e. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 2 times ULN f. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 3 times the ULN 8. Karnofsky Performance Score ≥ 70

Exclusion Criteria

Multifocal, deep midline, infratentorial, recurrent, leptomeningeal or extracranial disease. 2. Patients who are pregnant or breastfeeding. 3. Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with history of HCV adequately treated such that RNA viral load is negative also remain eligible. 4. Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator, including but not limited to uncontrolled or severe cardiac disease, systemic autoimmune disorders requiring immunosuppression in the past 2 years, autoimmune hyper/hypothyroidism, untreated vi-ral hepatitis, autoimmune hepatitis. 5. Treatment with another investigational drug or other experimental intervention within the last 30 days.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental DOC1021 + pIFN + SOC	DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment	Biological: DOC1021 Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method Procedure: Tumor resection SOC brain tumor resection Drug: Temodar (Temozolomide) SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation Radiation: SOC cranial radiation 60Gy radiation over 6 weeks in 2Gy fractions
Active Comparator SOC	Standard of Care treatment alone	Biological: DOC1021 Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method Procedure: Tumor resection SOC brain tumor resection Drug: Temodar (Temozolomide) SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation Radiation: SOC cranial radiation 60Gy radiation over 6 weeks in 2Gy fractions

Recruiting Locations

City of Hope
Duarte, California 91010

Contact:
Zorica Simic
6262758069
info@coh.org

More Details

NCT ID: NCT06805305
Status: Recruiting
Sponsor: Diakonos Oncology Corporation

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.