[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-all-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-all-adult":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100616977","early-phase-1-clinical-study-of-lv009-injection-for-the-treatment-of-relapsedrefractory-cd19-positive-hematologic-and-lymphoid-malignancies-100616977",false,"NCT07312630","Clinical Study of LV009 Injection for the Treatment of Relapsed\u002FRefractory CD19-Positive Hematologic and Lymphoid Malignancies","Inclusion Criteria:\n\n* Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions\n* Expected survival time exceeds 12 weeks\n* ECOG performance status 0-2\n* Meets the NCCN guidelines' criteria for recurrence\u002Frefractory disease and is diagnosed with CD19-positive hematologic malignancies, including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)\n* Liver and kidney function, as well as cardiopulmonary function, meet requirements.\n* Absolute lymphocyte count ≥ 0.5 × 10⁹\u002FL; platelet count ≥ 50 × 10⁹\u002FL; CD3-positive T cells ≥ 150 cells\u002FμL.\n* Subjects must have a body temperature ≤ 38°C (excluding tumor fever) within 24 hours prior to study drug infusion and must not have significant active infection.\n* Within 5 days prior to the study drug infusion, subjects must not receive therapeutic doses of corticosteroids (\\>5 mg\u002Fday of prednisone or other equivalent doses of corticosteroids) or other immunosuppressive agents.\n\nExclusion Criteria:\n\n* Patients deemed by the investigator to require long-term use of immunosuppressive agents during screening should be excluded.\n* Patients who have experienced a cerebrovascular accident or seizure within the six months prior to signing the informed consent form must be excluded.\n* Patients with malignant tumors other than the study disease must be excluded (only patients with carcinoma in situ may be considered for inclusion).\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer outside normal reference range; Hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis positive. (Patients meeting any criterion in this section must be excluded.)\n* Patients with severe cardiac conditions must be excluded, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), and severe arrhythmias.\n* Patients judged by the investigator to have unstable systemic diseases must be excluded, including but not limited to those with severe liver, kidney, or metabolic diseases requiring medication.\n* Patients with chronic progressive neurological diseases should be excluded.\n* Patients who have not recovered from acute toxic effects following prior treatment must be excluded.\n* Patients with active infections requiring systemic treatment or uncontrolled infections should be excluded (patients with mild urogenital tract infections and upper respiratory tract infections may be considered for inclusion).","ALL","18 Years","70 Years",{"count":19,"type":20},19,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed\u002Frefractory CD19-positive hematologic malignancies.",[26,27],"Non-Hodgkin Lymphoma (NHL)","Acute Lymphoblastic Leukemia (ALL), Adult",[29,30],"CD19","CAR-T","RECRUITING","2025-12-16",{"date":34,"type":35},"2025-12-31","ACTUAL",{"date":37,"type":35},"2025-09-25",{"date":39,"type":20},"2027-12-12",{"name":41,"class":42},"PersonGen BioTherapeutics (Suzhou) Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":67,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":43},"100546708","early-phase-1-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-before-standard-desensitization-and-allogeneic-peripheral-blood-stem-cell-transplantation-in-adult-patients-at-high-risk-for-primary-graft-failure-secondary-to-donor-specific-antibodies-100546708","NCT06398457","Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies","A Pilot Study of Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies","Inclusion Criteria:\n\n1. Participates must meet all other institutional criteria for the planned reduced intensity conditioning allogeneic peripheral blood stem cell transplant (RIC alloHSCT) as defined in Johns Hopkins BMT Policy; all potential non-cord blood donor sources are included: matched related, haploidentical, matched unrelated, mismatched unrelated.\n2. Participants must be ≥18 years of age.\n3. Participants must have adequate organ function for undergoing RIC allogeneic peripheral blood stem cell transplant, and for undergoing a clinical trial.\n\n   a. Hematologic. i. White blood cell (WBC). ANC ≥ 500\u002Fmm3 (growth factor support allowed). ii. Hemoglobin. No specific cut-off. (PRBC transfusion allowed). iii. Platelets. Platelets ≥ 10,000\u002Fmm3 (platelet transfusion allowed). b. Liver. Bilirubin ≤ 3.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \\\u003C 5x Upper limit of normal (ULN) c. Renal. Serum creatinine ≤ 2.0 mg\u002FdL. d. Cardiac. Left ventricular ejection fraction ≥ 35%. e. Pulmonary. FEV1 ≥ 50%.\n4. Subjects are eligible if there are high levels of Donor Specific Antibody levels based on protocol specific scoring system regardless of prior attempts at standard desensitization.\n5. Participants must have a no other readily available suitable alternative donor.\n6. All potential Participants must be pre-approved by BMT faculty consensus.\n7. Participants must have adequate willingness to participate in a clinical trial.\n\nExclusion Criteria:\n\n1. Previous exposure to Daratumumab-SC or other anti-CD38 therapy\n\n   1. Exposure to Daratumumab-SC or other anti-CD38 therapies (unless a re-treatment study)\n   2. Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.\n   3. Focal radiation therapy within 14 days prior to beginning of planned RIC allogeneic peripheral blood stem cell transplant regimen with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma\n2. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \\\u003C 50% of predicted normal.\n3. Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.\n4. Known hypersensitivity or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients\n5. Diagnosis of multiple myeloma or Amyloid light-chain (AL) amyloidosis\n6. A planned myeloablative alloBMT or the planned use of bone marrow or cord blood as a stem cell source\n7. History of HIV infection at any time in past.\n8. Seropositive for hepatitis B (HBV) (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\] positive, or antibodies to hepatitis B surface and\u002For core antigens \\[antiHBs or antiHBc, respectively\\] with hepatitis B virus \\[HBV\\]- DNA quantitation positive). Patients who are positive for antiHBs and\u002For antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result during screening. Patients with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. Those who are PCR positive will be excluded.\n9. Seropositive for hepatitis C (except in the setting of a sustained virologic response (SVR), defined as aviremia at least 12 weeks after completion of antiviral therapy)\n10. Clinically significant cardiac disease, including:\n\n    1. Myocardial infarction within 6 months before RIC alloHSCT or unstable or uncontrolled disease\u002Fcondition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)\n    2. Uncontrolled cardiac arrhythmia",{"count":52,"type":20},8,[23],"This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a stem cell transplant.",[56,57,58,59,27,60,61,62,63,64,65,66],"Hematologic Malignancy","Bone Marrow Transplant Rejection","Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes (MDS)","Multiple Myeloma","Aplastic Anemia","Lymphoma","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Chronic Myeloid Leukemia","Myelofibrosis",[68,69,70,71,72],"DSA","donor specific antibodies","desensitization","BMT","allogeneic stem cell transplant",{"date":74,"type":35},"2025-09-26",{"date":76,"type":35},"2024-09-19",{"date":78,"type":20},"2027-03",{"name":80,"class":81},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER"]