Clinical trial NCT06805305: Dendritic Cell Immunotherapy for Treatment of Adult GBM
Official title: Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioblastoma (GBM)
Keywords: Dendritic Cell Vaccine
Immunotherapy
Tumor vaccine
Lead sponsor: Diakonos Oncology Corporation
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. 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:

1. 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.

Primary outcomes:
measure: Time in months from initial diagnosis of new diagnosed GBM until death for each participant
timeFrame: 5 years
Secondary outcomes:
measure: Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
timeFrame: 1 years
measure: Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
timeFrame: 2 years
measure: Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
timeFrame: 3 years
measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: 3 years
measure: Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants
timeFrame: 3 years
Other outcomes:
measure: Health-related quality of life in all participants as assessed by EORTC Quality of Life Questionnaire Cancer QLC-C30 (Cancer 30-items) with QLQ-BN20 (Brain 20-items) module included.
timeFrame: 5 years
measure: Neuro-cognitive function in all participants as Assessed by the Neurologic Assessment in Neuro-Oncology (NANO) scale
timeFrame: 5 years
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Summit
country: United States
facility: Atlantic Health
state: New Jersey
Study officials:
References: