[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AVM Biotechnology Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100387821","phase-1-the-opal-study-avm0703-for-treatment-of-lymphoid-malignancies-100387821",false,"NCT04329728","The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies","An Open Label, Phase 1\u002F2 Study Evaluating Immunomodulatory AVM0703 in Patients With Lymphoid Malignancies (OPAL Study)","OPAL","Inclusion Criteria:\n\n* 1\\. Age ≥12 years and weight ≥40 kg;\n\n  2\\. Histologically confirmed diagnosis per 2016 World Health Organization (WHO) classification of lymphoid neoplasms160 and per the 2016 WHO classification of acute leukemia161 of the following indications:\n  * DLBCL, including arising from follicular lymphoma;\n  * High-grade B-cell lymphoma;\n  * MCL;\n  * Primary mediastinal large B-cell lymphoma;\n  * Primary DLBCL of the CNS;\n  * Burkitt or Burkitt-like lymphoma\u002Fleukemia;\n  * CLL\u002FSLL; or\n  * B-lymphoblastic leukemia\u002Flymphoma, T-lymphoblastic leukemia\u002Flymphoma, acute leukemia\u002Flymphoma, acute leukemias of ambiguous lineage, or NK cell lymphoblastic leukemia\u002Flymphoma;\n\n    3\\. Patients must have relapsed or refractory (R\u002FR) disease with prior therapies defined below:\n  * DLBCL and high-grade B-cell lymphoma:\n\n    e) R\u002FR after autologous hematopoietic cell transplant (HCT); or f) R\u002FR after chimeric antigen receptor T-cell (CAR T) therapy; or g) Patients not eligible for autologous HCT or CAR T therapy; or h) R\u002FR after ≥2 lines of therapy including anti-CD20 antibody and failed, intolerant or ineligible for polatuzamab vedotin, or for whom no standard therapy is available.\n  * MCL:\n\n    c) R\u002FR after autologous HCT; or d) Patients not eligible for autologous HCT must have failed acalabrutinib or be R\u002FR after ≥2 lines of therapy including at least 1 of the following: a Bruton's tyrosine kinase (BTK) inhibitor, bortezomib, or lenalidomide; or for whom no standard therapy is available;\n  * Primary mediastinal large B-cell lymphoma: R\u002FR after ≥1 line of therapy and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;\n  * Primary DLBCL of the CNS: R\u002FR after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;\n  * Burkitt or Burkitt-like lymphoma\u002Fleukemia: R\u002FR after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;\n  * CLL\u002FSLL: patients who have active disease requiring treatment and who are deemed at high-risk for disease progression by the investigator or have high risk features per the iwCLL criteria, such as primary resistance to first-line chemo(immune)therapy, or progression of disease \\\u003C3 years after fludarabine-based chemo(immune)therapy, or leukemia cells with del(17p)\u002FTP53 mutation, must be:\n\n    d) R\u002FR after autologous or allogeneic HCT; or e) Patients not eligible for HCT; or f) R\u002FR after ≥2 lines of therapy including at least 1 of the following: a BTK inhibitor, venetoclax, idelalisib, or duvelisib, or for whom no standard therapy is available;\n  * Acute lymphoblastic leukemia (ALL):\n\n    c) R\u002FR after allogeneic HCT and for whom no standard therapy is available; or d) Patients not eligible for allogeneic HCT must be R\u002FR according to the following disease specific specifications:\n  * B-cell lymphoblastic leukemia\u002Flymphoma: ≥2 lines of therapy including approved CAR T cell therapies, inotuzumab ozogamicin, or blinatumomab, or for whom no standard therapy is available;\n  * T-cell lymphoblastic leukemia\u002Flymphoma: ≥2 lines of therapy including nelarabine, or for whom no standard therapy is available;\n  * NK cell leukemia\u002Flymphoma: ≥1 line of therapy or for whom no standard therapy is available;\n  * All other diagnoses: R\u002FR after autologous or allogeneic HCT; or R\u002FR after at least one line of therapy, or for whom no standard therapy is available.\n\n    4\\. Lansky (12 to 15 years of age) (Appendix G) or Karnofsky (≥16 years of age) (Appendix H) performance status ≥50;\n\n    5\\. Screening laboratory values that meet all of the following criteria:\n  * Absolute neutrophil count ≥0.05 × 109\u002FL;\n  * Platelet count ≥25 × 109\u002FL;\n  * Hemoglobin ≥6.5 g\u002FdL;\n  * • Aspartate aminotransferase or alanine aminotransferase ≥2.5 × ULN, unless due to the disease;\n  * Total bilirubin \\\u003C1.5 × ULN (if secondary to Gilbert's syndrome, \\\u003C3 × ULN is permitted), unless due to the disease; and\n  * Glomerular filtration rate ≥30 mL\u002Fmin ; except for patients on metformin at baseline GFR must be ≥45 mL\u002Fmin; GFR can be calculated by the Cockcroft-Gault formula Appendix C);\n\n    6\\. Minimum level of pulmonary reserve defined as \\\u003CGrade 2 dyspnea and pulse oximetry ≥92% on room air;\n\n    7\\. Females of childbearing potential must have a negative serum pregnancy test at screening. Females of childbearing potential and nonsterile males must agree to use medically effective methods of contraception from the time of informed consent\u002Fassent through 1 month after study drug infusion, which must, at a minimum, include a barrier method; and\n\n    8\\. The ability to understand and willingness to sign a written informed consent form (ICF) and the ability to adhere to the study schedule and prohibitions. Patients under the age of 18 years (or other age as defined by regional law or regulation) must be willing and able to provide written assent and have a parent(s) or guardian(s) willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to performance of any study-related procedure.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from participation in the study for Phase 2:\n\n  1. History of another malignancy, except for the following:\n\n     * Adequately treated local basal cell or squamous cell carcinoma of the skin;\n     * Adequately treated carcinoma in situ without evidence of disease;\n     * Adequately treated papillary, noninvasive bladder cancer; or\n     * Other cancer that has been in complete remission for ≥2 years. Patients with low-grade prostate cancer, on active surveillance, and not expected to clinically progress over 2 years are allowed;\n  2. Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start of AVM0703 administration, angina requiring therapy, symptomatic peripheral vascular disease, New York Heart Association Class III or IV congestive heart failure, left ventricular ejection fraction \\\u003C30%, left ventricular fractional shortening \\\u003C20%, or uncontrolled ≥Grade 3 hypertension (diastolic blood pressure \\>100 mmHg or systolic blood pressure \\>150 mmHg) despite antihypertensive therapy for patients ≥18 years of age, or uncontrolled stage 2 hypertension (diastolic blood pressure \\>90 mmHg or systolic blood pressure \\>140 mmHg) despite antihypertensive therapy for patients ≥12 years of age;\n  3. Significant screening electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation\u002Fflutter, second degree atrioventricular (AV) block type 2, third-degree AV block, ≥Grade 2 bradycardia, or heart rate corrected QT interval using Fridericia's formula \\>480 msec;\n  4. Known gastric or duodenal ulcer;\n  5. Uncontrolled type 1 or type 2 diabetes;\n  6. Known hypersensitivity or allergy to the study drug or any of its excipients;\n  7. Untreated ongoing bacterial, fungal, or viral infection (including upper respiratory tract infections) at the start of AVM0703 administration, including the following:\n\n     * Positive hepatitis B surface antigen and\u002For hepatitis B core antibody test plus a positive hepatitis B polymerase chain reaction (PCR) assay. Patients with a negative PCR assay are permitted with appropriate antiviral prophylaxis;\n     * Positive hepatitis C virus antibody (HCV Ab) test. Patients with a positive HCV Ab test are eligible if they are negative for hepatitis C virus by PCR;\n     * Positive human immunodeficiency virus (HIV) antibody test with detectable HIV load by PCR, or the patient is not able to tolerate antiretroviral therapy; or\n     * Positive tuberculosis test during screening; test must be positive and not indeterminate due to anergy; if the result is indeterminate due to anergy the patient must not have a history of recent exposure to tuberculosis. Patients in Phase 2 repeat dosing cohorts should not travel to any destination where they might be exposed to tuberculosis during their entire treatment period with AVM0703.\n  8. Received live vaccination within 8 weeks of screening;\n  9. Pregnant or breastfeeding;\n  10. Concurrent participation in another therapeutic clinical study (except AVM0703-001); or\n  11. Uncontrolled bipolar disorder or schizophrenia. Patients with a diagnosis, past or current, of bipolar disorder or schizophrenia or having a history of severe depression or substance abuse must be prophylactically treated with circadian physiologic hydrocortisone per section 5.5.3.3 CNS prophylaxis, without exception.","ALL","12 Years","95 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is an open-label, Phase 1\u002F2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.",[29],"Lymphoid Malignancies",[31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Diffuse large B-cell lymphoma (DLBCL)","B-cell lymphoma","Mantle cell lymphoma (MCL)","Primary mediastinal large B-cell Lymphoma","Primary DLBCL of the central nervous system (CNS)","Burkitt or Burkitt-like lymphoma\u002Fleukemia","Chronic lymphocytic leukemia (CLL)","Small lymphocytic leukemia (SLL)","B-cell leukemia\u002Flymphoma","T-cell leukemia\u002Flymphoma","Acute leukemias of ambiguous lineage","Natural Killer (NK) cell lymphoblastic leukemia\u002Flymphoma","Advanced or Aggressive lymphoma\u002Flymphoproliferative disease","Follicular Lymphoma","RECRUITING","2026-04-13",{"date":48,"type":49},"2026-04-15","ACTUAL",{"date":51,"type":49},"2020-11-06",{"date":53,"type":22},"2028-12-01",{"name":55,"class":56},"AVM Biotechnology Inc","INDUSTRY",11,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":4,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":88,"locationsCount":4},"100514124","expanded-access-to-immunomodulatory-avm0703-for-solid-tumor-and-blood-cancer-patients-100514124","NCT05974410","Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO. As of July 2024, 37 patients have been treated through this FDA-EAP including patients diagnosed with relapsed or recurring glioblastoma, inoperable\u002Fchemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell Non-Hodgkin's Lymphoma and metastatic pancreatic cancer. Drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"Glioblastoma","Squamous Cell Carcinoma","Hodgkin Lymphoma","Non-hodgkin Lymphoma","Breast Cancer","Prostate Cancer","Gastric Cancer","Ovarian Cancer","Acute Leukemia","Pancreatic Cancer","Spindle Cell Sarcoma","Cancer","Tumor, Solid","Tumor, Brain","Esophageal Andeocarcinoma","Mixed Phenotype AML","Desmoplastic Round Cell Sarcoma","AVAILABLE","2025-09-29",{"date":87,"type":49},"2025-10-02",{"name":55,"class":56},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100390606","phase-1-evaluating-avm0703-for-treatment-of-covid-19-or-influenza-mediated-ards-100390606","NCT04366115","Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS","A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome","AVM0703","Inclusion Criteria\n\nPatients who meet all of the following criteria will be eligible to participate in the study:\n\n1. Age ≥18 years;\n2. Must have laboratory confirmed COVID-19;\n3. Must have moderate or severe, immediately life-threatening COVID-19 or Influenza (A or B), as follows:\n\n   a. COVID-19 patients with ARDS (Berlin Criteria) as demonstrated by:\n\n   i. Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules;\n\n   ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and\n\n   iii. Impaired oxygenation defined as Moderate (partial pressure of oxygen \\[PaO2\\]:fraction of inspired oxygen \\[FiO2\\] ratio 100 mm Hg to \\\u003C200 mm Hg with positive end-expiratory airway pressure \\[PEEP\\] \\>5 cm H2O) or Severe (PaO2:FiO2 ratio \\\u003C100 mm Hg with PEEP\\>5 cm H2O) on more than 2 arterial blood gases at least 6 hours apart within a 24 hour period;\n\n   b. Influenza (A or B) patients with ARDS (Berlin Criteria) as demonstrated by:\n\n   i. Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules;\n\n   ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and\n\n   iii. Impaired oxygenation defined as Severe (PaO2:FiO2 ratio\\\u003C100 mm Hg with PEEP \\>5 cm H2O) on more than 2 arterial blood gases at least 6 hours apart within a 24 hour period;\n4. Requires invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) despite standard of care rescue measures (eg, prone positioning, and\u002For PEEP ladder, and\u002For inhaled pulmonary vasodilators, and\u002For recruitment maneuvers and\u002For neuromuscular blockade);\n5. Females of childbearing potential must have a negative serum pregnancy test at screening;\n6. Females of childbearing potential and nonsterile males must agree to use medically effective methods of contraception from the time of informed consent through 1 month after study drug infusion; and\n7. Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent\n\nExclusion Criteria\n\nPatients who meet any of the following criteria will be excluded from participation in the study:\n\n1. Moribund patient who, in the opinion of the Investigator, is not expected to survive at least 24 hours;\n2. Known hypersensitivity or allergy to the study drug or any of its excipients;\n3. D-dimer level \\>3 times above normal range;\n4. Known gastric or duodenal ulcer;\n5. Uncontrolled type 1 or type 2 diabetes, per judgment of the Investigator;\n6. Active and untreated bacterial, fungal, parasitic, or viral infection other than COVID-19 or Influenza (A or B). Patients with a history of a positive hepatitis B surface antigen and\u002For hepatitis B core antibody must have a negative hepatitis B polymerase chain reaction (PCR) assay result. Patients with history of a positive hepatitis C virus antibody test must have a negative hepatitis C PCR assay result;\n7. Positive testing for tuberculosis during screening;\n8. Known to have received a live vaccine within the previous 1 month;\n9. Immunocompromised patients, defined as those who have received a bone marrow or solid organ transplant on immunosuppressive therapy; or history of human immunodeficiency virus (HIV) infection who have not been taking anti retroviral therapy for at least 6 months before enrollment and\u002For with most recent CD4 count \\\u003C200 cells\u002FmL and\u002For most recent detectable viral load within the previous 6 months;\n10. Moderate to End-stage liver disease (Childs-Pugh Score \\>10);\n11. Dialysis-dependent due to underlying chronic renal disease. Note: patients who require dialysis for treatment of renal failure due to complications of COVID-19 or Influenza (A or B) infection are not excluded from enrollment;\n12. Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start of AVM0703 administration, including: angina requiring therapy, symptomatic peripheral vascular disease, New York Heart Association Class III or IV congestive heart failure, left ventricular ejection fraction \\\u003C30%, left ventricular fractional shortening \\\u003C20%, or uncontrolled Grade 3 hypertension (diastolic blood pressure \\[DBP\\] \\>100 mm Hg or systolic blood pressure \\[SBP\\] \\>150 mm Hg) despite antihypertensive therapy.\n\n    Note: patients with heart failure requiring medical support due solely to complications of COVID-19 infection are not excluded from enrollment;\n13. Significant screening 12-lead ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation\u002Fflutter, left bundle-branch block, second degree atrioventricular (AV) block type 2, third-degree AV block, Grade 2 bradycardia, or heart rate corrected QT interval using Fridericia's formula average of triplicate ECGs \\>450 ms;\n14. Manic-depressive disorder, schizophrenia, or a history of severe depression or substance abuse;\n15. Pregnant or breastfeeding;\n16. Concurrent enrollment in any other clinical study involving administration of a novel (ie, unapproved or not considered standard of care) investigational pharmacological agent(s). Concurrent enrollment in observational and device studies and studies involving administration of pharmacological agent(s) approved for other indications or considered emerging standard of care for treatment of COVID-19 (eg, hydroxychloroquine, remdesivir, low-dose dexamethasone), will be allowed if approved by the Sponsor;\n17. Treatment with standard of care or off-label treatments for COVID-19 (eg, remdesivir), not administered as part of a formal clinical study, where the first dose was initiated within 72 hours of study drug start; and\n18. Inability to obtain informed consent from the patient or legally authorized representative.","18 Years",{"count":99,"type":22},16,[25],"This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients.",[103,104,105],"ARDS","Covid19","Influenza, Human",[103,107,108],"COVID19","Influenza","NOT_YET_RECRUITING",{"date":87,"type":49},{"date":112,"type":22},"2026-12-01",{"date":114,"type":22},"2032-03-01",{"name":55,"class":56},""]