NCT06805305招募中2 期
Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma
Diakonos Oncology Corporation24 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年3月17日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 24
- 主要终点
- Overall survival (time in months from randomization until death for each participant)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age 18 years or older
- •Presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be potentially resectable and deemed to be a good candidate for post-operative standard of care temozolomide and radiation therapy.
- •Surgical objective is for gross total resection (GTR)/near-total resection (NTR) de-fined as ≥ 95% of contrast enhancing (CE) tumor removed plus ≤ 1 cm3 residual CE tumor. Patients with subtotal resection will still be eligible if at least 70% of the CE tumor is resected.
- •Eligibility will be confirmed after surgery when diagnosis of glioblastoma IDH-wt confirmed prior to randomization. Randomization can occur with only IDH1 immunohistochemistry and when additional molecular testing is available, if glioblastoma IDH-wt is not confirmed, the participant will be deemed a screen failure and replaced.
- •Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated.
- •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.
- •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.
- •Adequate kidney, liver, bone marrow function, and immune function, as follows:
- •Hemoglobin ≥ 8.0 gm/dL
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Platelet count ≥ 75,000/mm3
- •Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gault for-mula:
- •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
- •Karnofsky Performance Score ≥ 70
排除标准
- •Infratentorial, recurrent, leptomeningeal or extracranial disease.
- •Patients who are pregnant or breastfeeding.
- •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.
- •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 viral hepatitis, autoimmune hepatitis. *autoimmune disorders include but are not limited to rheumatoid arthritis, psoriasis and inflammatory bowel disease and immunosuppressive medications include DMARDs like methotrexate, TNF inhibitors, IL-6 receptor blockers, CD80/86 inhibitors, anti-CD20 and JAK inhibitors
- •Treatment with another investigational drug or other experimental intervention within the last 30 days.
研究组 & 干预措施
DOC1021 + pIFN + SOC
Experimental
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
干预措施: DOC1021 (Biological)
DOC1021 + pIFN + SOC
Experimental
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
干预措施: Tumor resection (Procedure)
SOC
Active Comparator
Standard of Care treatment alone
干预措施: Tumor resection (Procedure)
SOC
Active Comparator
Standard of Care treatment alone
干预措施: SOC cranial radiation (Radiation)
SOC
Active Comparator
Standard of Care treatment alone
干预措施: Temodar (Temozolomide) (Drug)
DOC1021 + pIFN + SOC
Experimental
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
干预措施: SOC cranial radiation (Radiation)
DOC1021 + pIFN + SOC
Experimental
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
干预措施: Temodar (Temozolomide) (Drug)
结局指标
主要结局
Overall survival (time in months from randomization until death for each participant)
时间窗: 5 years
Overall survival (time in months from randomization until death for each participant)
时间窗: 5 years
次要结局
- Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date(1 years)
- Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date(2 years)
- Number of Participants with Adverse Events as Assessed by CTCAE v5.0(3 years)
- Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants(3 years)
- Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date(1 years)
- Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date(2 years)
- Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date(3 years)
- Number of Participants with Adverse Events as Assessed by CTCAE v5.0(3 years)
- Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants(3 years)
研究者
研究点 (24)
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相关资讯
Diakonos Oncology to Present First-in-Class DOC1021 Dendritic Cell Therapy Data at Major Cancer Conferences- Diakonos Oncology will present clinical data on DOC1021 (dubodencel), a first-in-class patient-derived double-loaded dendritic cell therapy, at AACR and AAN conferences in April 2026.
- The AACR presentation will feature updated data from the ongoing Phase 1 pancreatic cancer study, while AAN will showcase first results from the expanded access glioblastoma program.
- DOC1021 combines tumor lysate and amplified tumor-derived mRNA to leverage a patient's full complement of tumor antigens for robust immune responses against malignancy.
- The therapy has received FDA Fast Track designation for both glioblastoma and pancreatic cancer programs, along with Orphan Drug Designation for glioblastoma treatment.6 months agoDiakonos Oncology's DOC1021 Clears First Safety Review in Phase 2 Glioblastoma Trial- Independent Data Safety Monitoring Board recommends continuation of Phase 2 DOC-GBM2 trial without modification after finding no safety concerns in the first six months of treatment.
- DOC1021 is a first-in-class patient-derived double-loaded dendritic cell therapy that combines tumor lysate and amplified tumor-derived mRNA to target the complete cancer antigen pool.
- The therapy's safety profile in the Phase 2 study remains consistent with prior Phase 1 data, providing confidence for continued development in newly diagnosed glioblastoma patients.
- Diakonos has received FDA Fast Track and Orphan Drug designations for DOC1021 in glioblastoma, with additional trials planned for pancreatic cancer and melanoma.7 months agoDiakonos Oncology Secures $7 Million CPRIT Grant to Advance DOC1021 Dendritic Cell Therapy in Refractory Melanoma- Diakonos Oncology received a $7 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), selected as one of only nine awardees from 164 applicants.
- The funding will support a Phase 1/2 clinical trial of DOC1021, a first-in-class double-loaded dendritic cell therapy, in patients with refractory melanoma beginning January 2026.
- DOC1021 combines tumor lysate and amplified tumor-derived mRNA to create a personalized immunotherapy that mimics viral infection to trigger powerful immune responses.
- The therapy addresses a critical unmet need for patients with refractory melanoma who no longer respond to immune checkpoint inhibitors and have limited treatment options.9 months agoDiakonos Oncology's DOC1021 Shows Promising Survival Signal in Phase 1 Pancreatic Cancer Trial- Diakonos Oncology presented Phase 1 data showing five of seven pancreatic cancer patients treated with DOC1021 remain alive with survival times ranging from 12.9 to 45.3 months.
- The patient-derived dendritic cell therapy was well tolerated with no dose-limiting toxicities observed and only mild flu-like symptoms as the most common adverse events.
- DOC1021 demonstrated favorable biomarker signatures including CD127 upregulation on circulating T-cells and Granzyme B upregulation in CD8+ cells, suggesting enhanced immune activity.
- The company has received FDA Fast Track designation for both pancreatic cancer and glioblastoma programs and is enrolling a second patient group for modified treatment sequencing.10 months ago