[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Diakonos Oncology Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100615092","phase-1-doc1021-dendritic-cell-immunotherapy-for-refractory-melanoma-100615092",false,"NCT07288112","DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma","Clinical Study of DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and avail-ability for the duration of the study\n3. Age 18 years or older\n4. 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\n5. Willing and able to withhold anti-PD-1 treatment from the time of enrollment through \\~6 weeks after the first DOC1021 administration\n6. One or more lesions available for biopsy or resection to yield at least 50 mg (e.g., 5 core biopsies) and preferably 100 mg of tumor for generating DOC1021 and at least 1 measurable target tumor lesion evaluable after DOC1021 by RECIST version 1.1.\n7. Brain metastases allowed if stable after prior treatment\n8. Ability to receive filgrastim (e.g. Neupogen), leukapheresis and perinodal injections of DOC1021 near regional nodes + weekly pIFN x 4 weeks.\n9. 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.\n10. Adequate kidney, liver, bone marrow function, and immune function, as follows:\n\n    1. Hemoglobin ≥ 8.0 gm\u002FdL (use of transfusion or other intervention to achieve is acceptable)\n    2. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n    3. Platelet count ≥ 75,000\u002Fmm3\n    4. Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin using Cockcroft and Gault formula:\n\n    i. For males = (140 - age\\[years\\]) x (body weight \\[kg\\]) \u002F (72 x serum creatinine \\[mg\u002FdL\\]) 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)\n11. Eastern Cooperative Group (ECOG) Performance Score 0 or 1\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breastfeeding.\n2. 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.\n3. 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\u002Fhypothyroidism, 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\u002F86 inhibitors, anti-CD20 and JAK inhibitors)\n4. 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.\n5. Treatment with another investigational drug or other experimental intervention within the last 30 days.","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.\n\nThe study consists of two components: an initial phase I safety study to confirm safety\u002Ftolerability of the treatment regimen, and, subsequently, a single-arm phase II cohort to assess efficacy of the treatment regimen.\n\nAll participants will:\n\n* Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection\n* Receive two doses of DOC1021 under image guidance 2 weeks apart\n* Receive subcutaneous pIFN injections weekly for a total of 4 doses in parallel with the DOC1021 injections\n* 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\n* Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive optional treatment with anti-PD1 agents",[27],"Refractory Melanoma",[29,30,31],"Dendritic Cell Vaccine","Immunotherapy","Tumor Vaccine","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2026-04-06",{"date":40,"type":20},"2033-01",{"name":42,"class":43},"Diakonos Oncology Corporation","INDUSTRY",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100577977","phase-2-doc1021-dendritic-cell-immunotherapy-for-treatment-of-newly-diagnosed-adult-glioblastoma-gbm-100577977","NCT06805305","DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)","Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Age 18 years or older\n4. 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.\n\n   1. Surgical objective is for gross total resection (GTR)\u002Fnear-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.\n   2. 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.\n   3. Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated.\n5. 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.\n6. 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.\n7. Adequate kidney, liver, bone marrow function, and immune function, as follows:\n\n   1. Hemoglobin ≥ 8.0 gm\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n   3. Platelet count ≥ 75,000\u002Fmm3\n   4. Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin using Cockcroft and Gault for-mula:\n\n   i. For males = (140 - age\\[years\\]) x (body weight \\[kg\\]) \u002F (72 x serum creatinine \\[mg\u002FdL\\]) 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\n8. Karnofsky Performance Score ≥ 70\n\nExclusion Criteria:\n\n1. Infratentorial, recurrent, leptomeningeal or extracranial disease.\n2. Patients who are pregnant or breastfeeding.\n3. 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.\n4. 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\u002Fhypothyroidism, 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\u002F86 inhibitors, anti-CD20 and JAK inhibitors\n5. Treatment with another investigational drug or other experimental intervention within the last 30 days.",{"count":53,"type":20},180,[24],"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.\n\nParticipants in the DOC1021 + pIFN + SOC arm will:\n\n* Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection\n* Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses\n* Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections\n\nBoth arms of the trial will:\n\n\\- 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",[57],"Glioblastoma (GBM)",[29,30,59],"Tumor vaccine",{"date":35,"type":36},{"date":62,"type":36},"2025-03-17",{"date":64,"type":20},"2032-03",{"name":42,"class":43},18,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":5},"100374566","phase-1-th-1-dendritic-cell-immunotherapy-plus-standard-chemotherapy-for-pancreatic-adenocarcinoma-100374566","NCT04157127","Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma","Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)","DECIST","Inclusion Criteria\n\nAn individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female, aged 18 years and older\n3. Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +\u002F- radiation prior to resection.\n4. Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:\n\n   1. Hemoglobin ≥ 8.0 gm\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n   3. Platelet count ≥ 75,000 \u002Fmm3\n   4. Total bilirubin ≤ 1.5 times upper limit of normal (ULN),\n   5. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN\n5. ECOG performance status ≤ 2.\n6. For women of childbearing potential (WOCBP): use of highly effective contraception must be discussed with participants. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and continue for at least 12 weeks after her last vaccination.\n7. WOCBP must have a negative serum pregnancy prior to vaccination\n8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination.\n9. Patient must agree to not donate blood for up to 90 days after last vaccination.\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unresectable or metastatic (stage IV) pancreatic cancer.\n2. Patients with known HIV and a positive viral load.\n3. Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C RNA viral load negative will not be excluded.\n4. Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g. patient with psoriatic arthritis are excluded) are eligible provided all of the following conditions are met:\n\n   1. Rash that covers less than 10 % of body surface area.\n   2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n   3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n5. Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator.\n6. Female patients who are pregnant, breastfeeding, or of childbearing potential without a negative pregnancy test within 28 days (or decline contraception requirements as outlined above). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.\n7. Patients unwilling or unable to comply with the protocol or provide informed consent.\n8. Any severe or uncontrolled medical condition or other condition that could affect participation in this study (in the opinion of the investigator), including but not limited to hyper\u002Fhypothyroidism, active systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.\n9. Requires chronic treatment with a systemic steroid (⩾10 mg\u002Fday of prednisone equivalent) or with any systemic immunosuppressive agent.",{"count":66,"type":20},[23],"This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC.",[79,80,81],"Pancreatic Adenocarcinoma","Pancreatic Cancer","Pancreatic Adenosquamous Carcinoma",[30,83,84],"Adjuvant therapy","Cell Therapy","2025-05-21",{"date":87,"type":36},"2025-05-25",{"date":89,"type":36},"2020-08-03",{"date":91,"type":20},"2027-12",{"name":42,"class":43},""]