NCT07288112招募中1 期
Clinical Study of DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
Diakonos Oncology Corporation8 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年4月6日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Phase I: To evaluate the number of dose limiting toxicities reported
研究概览
简要总结
The goal of this clinical trial is to learn if DOC1021 + pIFN will be safe and will lead to tumor responses in patients with refractory melanoma. DOC1021 is a dendritic cell immunotherapy derived from a patient's own blood cells and loaded with antigens from the patient's tumor in the form of tumor lysate and mRNA. The goal is to stimulate a T cell immune response that eliminates tumor cells.
The study consists of two components: an initial phase I safety study to confirm safety/tolerability of the treatment regimen, and, subsequently, a single-arm phase II cohort to assess efficacy of the treatment regimen.
All participants will:
- Undergo a leukapheresis collection (take filgrastim subcutaneously x 5 doses, if clinically necessary, leading up to collection)
- Receive two doses of DOC1021 under image guidance 2 weeks apart
- Receive subcutaneous pIFN injections weekly for a total of 4 doses in parallel with the DOC1021 injections
- Undergo an optional image-guided perinodal DOC1021 booster injection approximately 6 months after the first DOC1021 dose along with additional subcutaneous pIFN injections at time of the booster and the subsequent week for a total of 2 pIFN doses
- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive optional treatment with anti-PD1 agents
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 avail-ability for the duration of the study
- •Age 18 years or older
- •Patients diagnosed with unresectable or metastatic melanoma and progressed following ≥1 prior systemic therapy including anti-PD-1 (i.e., refractory to anti-PD-1). Refractory defined as primary or secondary resistance as per SITC guidelines, except that confirmatory scan not required if clinical progression requiring surgery or radiation to relieve symptoms
- •Willing and able to withhold anti-PD-1 treatment from the time of enrollment through at least 6 weeks after the first DOC1021 administration
- •One or more lesions available for biopsy or resection expected to yield at least 50 mg and preferably 100 mg of tumor for generating DOC1021 and at least 1 measurable target tumor lesion evaluable after DOC1021 by RECIST version 1.
- •Brain metastases allowed if stable after prior treatment
- •Ability to receive leukapheresis (with filgrastim if clinically indicated) and perinodal injections of DOC1021 near regional nodes + weekly pIFN x 4 weeks (i.e., sufficient clinical stability and anticipated life expectancy to complete the treatment period and allow time for an immune response to develop).
- •Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as deter-mined 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 (use of transfusion or other intervention to achieve is acceptable)
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Platelet count ≥ 75,000/mm3
- •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 ≤ 3 times ULN f. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 3 times the ULN (or ≤ 5.0 × ULN if liver metastases)
- •Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
排除标准
- •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 dis-ease, systemic autoimmune disorders requiring immunosuppression*, 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)
- •Residual immune-related toxicities from prior immunotherapy > Grade 1 severity. However, patients who experienced prior endocrine toxicity are eligible if well-controlled on replacement therapy.
- •Treatment with another investigational drug or other experimental intervention within the last 30 days.
研究组 & 干预措施
Experimental: DOC1021 + pIFN
Experimental
DOC1021 administered by injection near active tumor lesion lymph nodes + pIFN
干预措施: Tumor resection (Procedure)
Experimental: DOC1021 + pIFN
Experimental
DOC1021 administered by injection near active tumor lesion lymph nodes + pIFN
干预措施: pIFN (peginterferon alfa-2a) (Drug)
Experimental: DOC1021 + pIFN
Experimental
DOC1021 administered by injection near active tumor lesion lymph nodes + pIFN
干预措施: DOC1021 (Biological)
结局指标
主要结局
Phase I: To evaluate the number of dose limiting toxicities reported
时间窗: From time of first DOC1021 dose administration to 6 weeks later
Phase II: To evaluate the objective response rate (ORR) as the proportion of patients with a confirmed complete response (CR) or partial response (PR) to treatment, as per RECIST 1.1 criteria
时间窗: 5 years
次要结局
- Time in months from date of study enrollment to disease progression by RECIST 1.1 criteria or death from any cause(5 years)
- Overall survival (time in months from the date of study enrollment until death for from any cause)(5 years)
- Time in months from the first documentation of complete or partial response to disease progression by RECIST 1.1 criteria or death, whichever occurs first.(5 years)
- Time in months from date of study enrollment to disease progression by RECIST 1.1 criteria or death from any cause(3 years)
- The proportion of participants with complete response, partial response, or stable disease out of the total eligible and evaluable participants.(5 years)
- Number of participants with adverse events as assessed by CTCAE v5.0(3 years)
- To evaluate the objective response rate (ORR) as the proportion of patients with a confirmed complete response (CR) or partial response (PR) to treatment, as per immune-related response criteria (iRECIST)(5 years)
研究者
研究点 (8)
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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 ago