[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06805305":3,"trial-entities:NCT06805305":348,"trial-summary:NCT06805305":352},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":54,"secondary_outcomes":58,"sex":75,"minimum_age":76,"maximum_age":17,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":82,"locations":85,"central_contacts":340,"overall_officials":341,"references":342,"see_also_links":347},"NCT06805305","DOC-GBM2","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","RECRUITING","2032-03","2026-06","2026-07-01","2025-03-17","Diakonos Oncology Corporation","INDUSTRY",true,"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",null,[19],"Glioblastoma (GBM)",[21,22,23],"Dendritic Cell Vaccine","Immunotherapy","Tumor vaccine","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},180,"ESTIMATED",[32,38,44,49],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BIOLOGICAL","DOC1021","Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method",[37],"DOC1021 + pIFN + SOC",{"type":39,"name":40,"description":41,"armGroupLabels":42},"PROCEDURE","Tumor resection","SOC brain tumor resection",[37,43],"SOC",{"type":45,"name":46,"description":47,"armGroupLabels":48},"DRUG","Temodar (Temozolomide)","SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation",[37,43],{"type":50,"name":51,"description":52,"armGroupLabels":53},"RADIATION","SOC cranial radiation","60Gy radiation over 6 weeks in 2Gy fractions",[37,43],[55],{"measure":56,"timeFrame":57},"Overall survival (time in months from randomization until death for each participant)","5 years",[59,63,67,71,73],{"measure":60,"description":61,"timeFrame":62},"Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date","One-year survival","1 years",{"measure":64,"description":65,"timeFrame":66},"Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date","2-year survival rate","2 years",{"measure":68,"description":69,"timeFrame":70},"Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date","3-year survival","3 years",{"measure":72,"timeFrame":70},"Number of Participants with Adverse Events as Assessed by CTCAE v5.0",{"measure":74,"timeFrame":70},"Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants","ALL","18 Years",false,{"inclusion":79,"exclusion":80,"raw_text":81},[],[],"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.",[83,84],"ADULT","OLDER_ADULT",[86,96,113,127,141,156,169,184,198,212,226,241,255,270,285,300,315,326],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"Banner MD Anderson Cancer Center","ACTIVE_NOT_RECRUITING","Gilbert","Arizona","85234","United States",{"lat":94,"lon":95},33.35283,-111.78903,{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":92,"contacts":101,"geoPoint":110},"City of Hope","Duarte","California","91010",[102,107],{"name":103,"role":104,"phone":105,"email":106},"Zorica Simic","CONTACT","6262758069","info@coh.org",{"name":108,"role":109},"Jana Portnow, MD","PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},34.13945,-117.97729,{"facility":114,"status":8,"city":115,"state":99,"zip":116,"country":92,"contacts":117,"geoPoint":124},"HOAG","Newport Beach","92663",[118,122],{"name":119,"role":104,"phone":120,"email":121},"Julie Nguyen","949-764-4577","julie.nguyen@hoag.org",{"name":123,"role":109},"Simon Khagi, MD",{"lat":125,"lon":126},33.61891,-117.92895,{"facility":128,"status":8,"city":129,"state":99,"zip":130,"country":92,"contacts":131,"geoPoint":138},"UCSF","San Francisco","94143",[132,136],{"name":133,"role":104,"phone":134,"email":135},"Stephanie Lewis","415-353-2193","NeuroOncNewPatientCoord@ucsf.edu",{"name":137,"role":109},"Thomas Nelson, MD",{"lat":139,"lon":140},37.77493,-122.41942,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":92,"contacts":146,"geoPoint":153},"Baptist MD Anderson Cancer Center","Jacksonville","Florida","32207",[147,151],{"name":148,"role":104,"phone":149,"email":150},"Andres Alvarez, MD","9042027713","CTOinterest@bmcjax.com",{"name":152,"role":109},"Robert Cavaliere, MD",{"lat":154,"lon":155},30.33218,-81.65565,{"facility":157,"status":8,"city":158,"state":159,"zip":160,"country":92,"contacts":161,"geoPoint":166},"Dana-Farber Cancer Institute","Boston","Massachusetts","02115",[162],{"name":163,"role":104,"phone":164,"email":165},"Indira Balmasheva","877-338-7425","researchintegrity@dfci.harvard.edu",{"lat":167,"lon":168},42.35843,-71.05977,{"facility":170,"status":8,"city":171,"state":172,"zip":173,"country":92,"contacts":174,"geoPoint":181},"Cooper University Health Care","Camden","New Jersey","08103",[175,179],{"name":176,"role":104,"phone":177,"email":178},"Sean Behnke","856-342-2362","Behnke-Sean@CooperHealth.edu",{"name":180,"role":109},"Alan Turtz, MD",{"lat":182,"lon":183},39.92595,-75.11962,{"facility":185,"status":8,"city":186,"state":172,"zip":187,"country":92,"contacts":188,"geoPoint":195},"Rutgers Cancer Institute","New Brunswick","08901",[189,193],{"name":190,"role":104,"phone":191,"email":192},"Xiaoru Chen","732-235-2465","xc194@cinj.rutgers.edu",{"name":194,"role":109},"Morana Vojnic, MD",{"lat":196,"lon":197},40.48622,-74.45182,{"facility":199,"status":8,"city":200,"state":172,"zip":201,"country":92,"contacts":202,"geoPoint":209},"Atlantic Health","Summit","07901",[203,207],{"name":204,"role":104,"phone":205,"email":206},"Morgan Finlay","9085225985","Morgan.finlay@atlantichealth.org",{"name":208,"role":109},"Robert Aiken, MD",{"lat":210,"lon":211},40.71562,-74.36468,{"facility":213,"status":8,"city":214,"state":214,"zip":215,"country":92,"contacts":216,"geoPoint":223},"Lenox Hill Hospital","New York","10075",[217,221],{"name":218,"role":104,"phone":219,"email":220},"Sara Massimo","212-434-4482","smassimo@northwell.edu",{"name":222,"role":104},"John Boockvar, MD",{"lat":224,"lon":225},40.71427,-74.00597,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":92,"contacts":231,"geoPoint":238},"UNC Lineberger Comprehensive Cancer Center","Chapel Hill","North Carolina","27599",[232,236],{"name":233,"role":104,"phone":234,"email":235},"Claire Kowalczyk","877-668-0683","cancerclinicaltrials@med.unc.edu",{"name":237,"role":109},"Dominique Higgins, MD",{"lat":239,"lon":240},35.9132,-79.05584,{"facility":242,"status":8,"city":243,"state":229,"zip":244,"country":92,"contacts":245,"geoPoint":252},"Wake Forest University Health Sciences","Winston-Salem","27157",[246,250],{"name":247,"role":104,"phone":248,"email":249},"Sara Cox","336-713-7748","sara.cox@advocatehealth.org",{"name":251,"role":109},"Roy E Strowd III, MD",{"lat":253,"lon":254},36.09986,-80.24422,{"facility":256,"status":8,"city":257,"state":258,"zip":259,"country":92,"contacts":260,"geoPoint":267},"The Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",[261,265],{"name":262,"role":104,"phone":263,"email":264},"Clinical Research Coordinator","800-293-5066","jamesline@osumc.edu",{"name":266,"role":109},"J. Bradley Elder, MD",{"lat":268,"lon":269},39.96118,-82.99879,{"facility":271,"status":8,"city":272,"state":273,"zip":274,"country":92,"contacts":275,"geoPoint":282},"UPMC Presbyterian Hospital","Pittsburgh","Pennsylvania","15213",[276,280],{"name":277,"role":104,"phone":278,"email":279},"Theodore Estep","878-261-6727","esteptj2@upmc.edu",{"name":281,"role":109},"Costas Hadjipanayis, MS, MD, PhD",{"lat":283,"lon":284},40.44062,-79.99589,{"facility":286,"status":8,"city":287,"state":288,"zip":289,"country":92,"contacts":290,"geoPoint":297},"Vanderbilt-Ingram Cancer Center","Nashville","Tennessee","37203",[291,295],{"name":292,"role":104,"phone":293,"email":294},"VICC CTIP (Clinical Trials Info Program)","800-811-8480","cip@vumc.org",{"name":296,"role":109},"Ryan Merrell, MD",{"lat":298,"lon":299},36.16589,-86.78444,{"facility":301,"status":8,"city":302,"state":303,"zip":304,"country":92,"contacts":305,"geoPoint":312},"UTHealth Houston","Houston","Texas","77030",[306,310],{"name":307,"role":104,"phone":308,"email":309},"Austin Lu","7134868000","austin.lu@uth.tmc.edu",{"name":311,"role":109},"Nitin Tandon, MD",{"lat":313,"lon":314},29.76328,-95.36327,{"facility":316,"status":8,"city":302,"state":303,"zip":317,"country":92,"contacts":318,"geoPoint":325},"Baylor College of Medicine","77057",[319,323],{"name":320,"role":104,"phone":321,"email":322},"Glenn Wilson","713-798-2273","ggwilson@bcm.edu",{"name":324,"role":109},"Jacob Mandel, MD",{"lat":313,"lon":314},{"facility":327,"status":8,"city":328,"state":303,"zip":329,"country":92,"contacts":330,"geoPoint":337},"The University of Texas Health Science Center at San Antonio","San Antonio","78229",[331,335],{"name":332,"role":104,"phone":333,"email":334},"Leti Velten, RN","210-450-1921","Velten@uthscsa.edu",{"name":336,"role":109},"Andrew Brenner, MD, PhD",{"lat":338,"lon":339},29.42412,-98.49363,[],[],[343],{"pmid":344,"type":345,"citation":346},"41959823","DERIVED","Georges JF, Clay C, Amin S, Goralczyk A, Mossop C, Bilbao CJ, Valeri A, Ifrach J, Zaher M, Colman L, Kohler L, Schumann EH, Vu M, Burns BA, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste KJ, Bisht N, Vazquez-Perez J, Oyewole-Said D, Amanya SB, Rodriguez V, Kraushaar DC, Okoebor D, Bellayr I, Hartenbach J, Halpert MM, Duus EM, Aguilar LK, Hsu SH, Zhu JJ, Zvavanjanja RC, Bai Y, Kang SW, Jang HJ, Lee HS, Garg R, Esquenazi Y, Tandon N, Turtz A, Konduri V, Decker WK. Phase I Clinical Study of DOC1021 (dubodencel) for Adjuvant Immunotherapy of Glioblastoma. medRxiv [Preprint]. 2026 Apr 2:2026.03.28.26349013. doi: 10.64898\u002F2026.03.28.26349013.",[],{"nct_id":4,"conditions":349,"biomarkers":351},[350],"Glioblastoma",[],{"nct_id":4,"found":15,"summary":353,"prompt_version":363},{"design":354,"status":355,"heading":356,"summary":357,"follow_up":358,"word_count":359,"commitments":360,"compensation":361,"drugs_mentioned":362},"This interventional study plans to enroll 180 participants. It compares DOC1021 plus standard care to standard care alone.","completed","DOC1021 Immunotherapy for Newly Diagnosed Glioblastoma","This study is testing a new immunotherapy called DOC1021 for adults recently diagnosed with glioblastoma (a type of brain cancer). Researchers want to see if adding DOC1021 and pIFN (another treatment) to standard care improves how long patients live, and if it is safe. DOC1021 is a \"dendritic cell vaccine\" that uses your own immune cells to fight the cancer. You might be able to join if you are 18 or older, have newly diagnosed glioblastoma (specifically, IDH-wt type), and are a candidate for surgery. The study aims to enroll 180 participants. The main goal is to measure overall survival (how long patients live) over 5 years.","Participants' overall survival will be measured for up to 5 years after they join the study.",107,"If you are in the DOC1021 group, you will have a blood collection (leukapheresis), receive three DOC1021 injections every two weeks, and six weekly pIFN injections. All participants will have regular clinic visits to check quality of life and symptoms.","Not stated in the trial record.",[34],"v2"]