[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphobkastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphobkastic-leukemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,72,101,126,152,182],{"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":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100631643","phase-1-a-phase-12-study-of-t-cell-expressing-a-novel-cd19-chimeric-antigen-receptor-shb-02-cd19-in-patients-with-cd19-expressing-b-cell-malignancies-100631643",false,"NCT07503353","A Phase 1\u002F2 Study of T-cell Expressing a Novel CD19 Chimeric-Antigen Receptor (SHB-02-CD19) in Patients With CD19-expressing B-cell Malignancies","Inclusion Criteria:\n\n* Patient must have a CD19-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy and not eligible for current commercial CD19 CAR T cells per Israeli MOH health basket:\n\n  1. Relapse following standard relapse protocol (2nd relapse)\n  2. Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy.\n  3. Patients who have histologically confirmed large B-cell lymphoma, according to the World Health Organization 2016 classification criteria, that are refractory to first-line treatment or that have relapsed from complete remission no more than 12 months after the completion of first-line chemo-immunotherapy including an anti-CD20 monoclonal antibody and anthracycline-containing regimen.\n  4. Very high risk 1st relapse of ALL, defined as (a) relapse within 18 months of initial diagnosis; (b) relapse with the following cytogenetic abnormalities: KMT2a-R, TCF3::HLF, TCF3::PBX1, TP53-alterations.\n* Age 1-80 years\n* For ALL, CD19 expression shown by flow cytometry or immunohistochemistry on at least 70% of leukemic blasts.\n* Adequate CD3 count (above 120 CD3+ cells per microliter blood)\n* Clinical performance status: Patients \\> 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy.\n* Females of child-bearing potential must have a negative pregnancy test\n* Cardiac function: LV ejection fraction \\>45% or shortening fraction \\>28%\n* At least 60 days after autologous or allogeneic BMT\n* No prior CD19 CAR T cell administered\n* Prior therapy:\n\n  1. Patients should be off steroids for at least 2 weeks prior to apheresis\n  2. Patients should be off systemic anti-neoplastic treatment for 2 weeks prior to apheresis, with the exception of intrathecal chemotherapy. Patients who received prior clofarabine and fludarabine should have a wash out period of 3 months prior to apheresis.\n  3. Patients should have recovered from all toxicities attributed to prior therapy. Cytopenias that are considered disease related rather than therapy related are exempt from this exclusion.\n  4. Radiation therapy should be completed at least 3 weeks prior to apheresis.\n\nExclusion Criteria:\n\n* Hyperleukocytosis (WBC\\>50,000) or rapidly progressive disease that in the judgment of the PI can compromise the ability of the patient to complete the study\n* Pregnant or breast-feeding females\n* Hepatic dysfunction, defined as bilirubin \\> x2 upper normal limit (except when explained by hemolysis or Gilbert) or SGOT \\> x2.5 upper normal limit.\n* Active HIV infection, HBV or HCV infection which is identified by positive PCR of viral sequences. Patients who are positive for HCV Abs, HBsAg and\u002For positive to HBcAbs total, will be evaluated by PCR of viral sequences. If PCR is positive, the patient will be excluded.","ALL","1 Year","80 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a phase I\u002FII trial of SHB-02-CD19, T-cell expressing an anti-CD19 Chimeric-Antigen-Receptor (CAR) in patients with CD19 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed\u002Frefractory B-cell malignancies.",[27,28,29],"B Cell Malignancies","Acute Lymphobkastic Leukemia","Non-Hodgekin Lymphoma (NHL-both Follicular & Diffuse Large Cell)",[15,31,32,33,34],"DLBCL","NHL","CAR-T","CD-19","NOT_YET_RECRUITING","2026-03-25",{"date":38,"type":39},"2026-03-31","ACTUAL",{"date":41,"type":20},"2026-06",{"date":43,"type":20},"2030-01",{"name":45,"class":46},"Sheba Medical Center","OTHER_GOV",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100562245","a-study-to-determine-number-of-patients-who-develop-high-ammonia-levels-after-receiving-recombinant-erwinia-asparaginase-100562245","NCT06600659","A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase","A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase","Inclusion Criteria:\n\n* Followed by pediatric hematology\u002Foncology\n* Receiving recombinant Erwinia asparaginase for treatment of malignancy\n\nExclusion Criteria:\n\n* Patients \\\u003C 1 year of age\n* Patients who have previously received recombinant Erwinia asparaginase within the past two weeks",{"count":56,"type":20},10,"OBSERVATIONAL","This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.",[60,28],"Hematopoietic and Lymphatic System Neoplasm","RECRUITING","2026-02-04",{"date":64,"type":39},"2026-02-06",{"date":66,"type":39},"2023-11-02",{"date":68,"type":20},"2026-12-01",{"name":70,"class":71},"Mayo Clinic","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":15,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100620387","evaluation-of-the-efficacy-of-ponatinib-in-ph-all-in-the-real-world-100620387","NCT07356960","Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world","Retrospective, Observational, Study on the Evaluation of the Real-world Outcome of Philadelphia-positive Acute Lymphoblastic Leukaemia Patients Treated With Ponatinib as First-line Treatment Under the Italian Law 648\u002F96 (PONA4ALL Ph+)","PONA4ALL Ph+","Inclusion Criteria:\n\n1. Patient is \\> 18 years old;\n2. Patient was treated in first-line with ponatinib monotherapy or in association with chemotherapy or immunotherapy;\n3. Patient received ponatinib under the regulations of Law 648\u002F96;\n4. \\- Patient is alive and have at least 18 months of retrospective observation available from the start of ponatinib treatment, OR\n\n   \\- has died\u002Flost to follow-up at any time after treatment initiation, regardless of the length of available follow-up;\n5. Signed informed consent, if applicable.\n\nExclusion Criteria:\n\n* None","18 Years",{"count":82,"type":20},103,"The goal of this retrospective observational study is to learn about the efficacy of ponatinib in Philadelphia-positive ALL (Ph+ ALL) patients in a real-world setting. The main goal of the study is to assess the rate of complete molecular response (CMR) induced by ponatinib in patients treated under the regulations of Law 648\u002F96, outside clinical trials.\n\nPatients who were treated with ponatinib as part of their regular medical care and completed the follow-up period will be included in the study.",[28,85],"Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",[87,88,89,90,91],"ponatinib","real-world","philadelphia-positive acute lymphoblastic leukemia","Ph+ ALL","adult","2026-01-12",{"date":94,"type":39},"2026-01-21",{"date":96,"type":20},"2026-04-02",{"date":98,"type":20},"2029-06-30",{"name":100,"class":71},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":15,"minAge":80,"maxAge":4,"enrollmentInfo":109,"targetDuration":16,"studyType":57,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100612781","efficacy-of-dose-adjusted-regimen-on-survival-in-frail-adults-with-acute-lymphoblastic-leukemia-100612781","NCT07258043","Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia","Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia","EPOCH","Inclusion Criteria:\n\n* Diagnosed with acute lymphoblastic leukemia (ALL) according to the World Health Organization (WHO) criteria\n* Older than 18 years old\n* ECOG Performance Status Scale \\>1 or the Karnofsky Performance Status (KPS) \\\u003C80%.\n* Comorbidities: diabetes mellitus, arterial hypertension, thrombotic events, endocrine disorders, or any condition that hinders the administration of full-dose chemotherapy.\n* Toxicity prior to a standard chemotherapy regimen.\n* Both genders\n* Over 18 years of age\n* No upper age limit\n* Signed informed consent\n\nExclusion Criteria:\n\n´- Patients refractory to induction treatment\n\n* Patients who have previously received a low-intensity regimen due to comorbidities\n* Biphenotypic leukemia\n* CNS involvement at diagnosis requiring radiotherapy\n* Patients whose survival is expected to be less than 48 hours due to leukemiarelated complications\n* Patients with a history of ischemic or hemorrhagic stroke or severe neurological deterioration\n* Pregnant patients",{"count":110,"type":20},45,"Acute lymphoblastic leukemia (ALL) is characterized by the abnormal proliferation of immature precursor cells, disrupting normal hematopoiesis and causing severe anemia and thrombocytopenia due to genetic mutations. Conventional treatment with intensive chemotherapy is limited for elderly patients or those with comorbidities, adversely affecting their survival. In Mexico, alongside a higher incidence, treatment-related complications are more frequent, particularly with drugs such as asparaginase or anthracyclines, which limits therapeutic efficacy. The transition to infusion-based therapies promises to reduce these complications, improve treatment tolerance, and optimize clinical outcomes, marking a significant advancement in the management of this disease. Modifying treatment regimens toward infusion therapies has the potential to significantly reduce adverse complications, enhance treatment tolerance, and ultimately improve clinical outcomes for patients who cannot benefit from conventional intensive regimens. This approach not only aims to optimize treatment effectiveness but also to minimize associated risks, thus representing an important advancement in the management of acute lymphoblastic leukemia in clinical settings such as those in Mexico",[28,113,114],"Leukemia","Overall Survival",[116,107],"acute lymphoblastic leukemia","2025-11-26",{"date":119,"type":39},"2025-12-02",{"date":121,"type":39},"2025-07-23",{"date":123,"type":20},"2026-07-26",{"name":125,"class":46},"Hospital General de Mexico",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":80,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100611797","to-evaluate-the-safety-tolerability-and-preliminary-antitumor-activity-of-str-p004-100611797","NCT07245251","To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004","An Early-Phase Clinical Study Evaluating the Safety and Clinical Efficacy of STR-P004 in Subjects With Relapsed\u002FRefractory CD19-Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\nSubjects with relapsed\u002Frefractory CD19-positive B-cell acute lymphoblastic leukemia who currently have poor prognosis treatment options:\n\n1. Patients voluntarily sign the informed consent form;\n2. Age between 18 and 65 years, regardless of gender;\n3. Diagnosed with B-cell acute lymphoblastic leukemia and meeting any of the following conditions:\n\n   * (1) Relapse: Relapse within 12 months after first remission following standard treatment;\n   * (2) Refractory:\n\n     1. No remission after ≥6 weeks of induction therapy or two courses of induction therapy;\n     2. Relapse after ≥2 complete remissions (CR) or CR with incomplete hematologic recovery (CRi);\n     3. First relapse after chemotherapy, with no remission after at least one salvage therapy;\n   * d) Relapse after autologous or allogeneic hematopoietic stem cell transplantation;\n4. Within 3 months before screening, bone marrow or peripheral blood tests show leukemia cells expressing CD19;\n5. For Ph+ ALL patients, treatment failure with at least two tyrosine kinase inhibitors (TKIs) (including at least one second-generation TKI) or intolerance to TKI therapy; if the patient has a T315I mutation, TKI salvage therapy is not required;\n6. During screening, the proportion of bone marrow blasts and immature lymphocytes is ≥5%;\n7. Hemoglobin ≥60 g\u002FL, platelets ≥30 × 10\\^9\u002FL;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n9. Adequate organ function, meeting the following criteria:\n\n   * Aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) ≤3 × ULN;\n   * Total serum bilirubin ≤2 × ULN, unless combined with Gilbert's syndrome; patients with Gilbert's syndrome may be included if total serum bilirubin ≤3.0 × ULN and direct bilirubin ≤1.5 × ULN;\n   * Serum creatinine ≤2.0 × ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft and Gault formula);\n   * Minimum lung reserve: defined as ≤ grade 1 dyspnea and oxygen saturation \\>91% without oxygen supplementation;\n   * International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (APTT) ≤1.5 × ULN;\n10. Women of childbearing potential must have a negative blood\u002Furine pregnancy test during screening and within 3 days before dosing. Any patient with reproductive potential must agree to use effective contraception throughout the study and for at least 2 years after the last dose of study treatment. As judged by the investigator, patients are considered to have reproductive potential if they are biologically capable of having children and have normal sexual activity. Female patients without reproductive potential (i.e., meeting at least one of the following criteria): hysterectomy, bilateral oophorectomy, bilateral tubal ligation, medically confirmed ovarian failure, or medically confirmed menopause (≥12 consecutive months of amenorrhea).\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria cannot be enrolled:\n\n1. Active central nervous system (CNS) leukemia (patients with CNS disease symptoms must undergo lumbar puncture to exclude CNS leukemia);\n2. Isolated extramedullary relapse;\n3. Prior CAR-T therapy or other genetically modified cell therapy within 6 months before screening;\n4. Chemotherapy within 2 weeks before dosing, except for the following:\n\n1\\.\n\n* Pre-treatment chemotherapy as specified in the protocol;\n* TKI and hydroxyurea must be discontinued 72 hours before cell infusion;\n* 6-mercaptopurine, 6-thioguanine, methotrexate (standard dose), cytarabine (standard dose), vincristine, and asparaginase must be discontinued 1 week before cell infusion;\n* Intrathecal chemotherapy for CNS leukemia prophylaxis must be discontinued 1 week before cell infusion; 2. Systemic corticosteroid therapy discontinued for less than 72 hours before dosing, except for physiological replacement doses (e.g., prednisone \\\u003C10 mg\u002Fday or equivalent); 3. Acute graft-versus-host disease (GVHD) within 4 weeks before screening or moderate to severe chronic GVHD; systemic medication for GVHD within 4 weeks before dosing; 4. Active systemic autoimmune disease under treatment; 5. Any of the following:\n* Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive;\n* Hepatitis B e antibody (HBe-Ab) positive with HBV-DNA copy number above the lower limit of quantification;\n* Hepatitis C antibody (HCV-Ab) positive;\n* Anti-Treponema pallidum antibody (TP-Ab) positive;\n* Human immunodeficiency virus (HIV) antibody positive;\n* EBV-DNA or CMV-DNA copy number above the lower limit of quantification; 6. History or presence of other malignancies within 5 years before screening, except for those with low risk of recurrence as judged by the investigator after curative treatment and follow-up for more than 5 years; 7. Any of the following cardiac conditions:\n* Left ventricular ejection fraction (LVEF) ≤45% (ECHO);\n* New York Heart Association (NYHA) class III or IV congestive heart failure;\n* Severe arrhythmia requiring treatment or clinically significant conduction abnormalities on ECG, including QTc interval ≥480 ms (QTcB = QT\u002FRR\\^(1\u002F2));\n* Uncontrolled hypertension (systolic pressure ≥140 mmHg and\u002For diastolic pressure ≥90 mmHg) or pulmonary hypertension despite standard treatment;\n* Unstable angina;\n* Myocardial infarction or coronary artery bypass graft\u002Fstent surgery within 6 months before dosing;\n* Clinically significant valvular disease;\n* Other cardiac diseases deemed unsuitable for enrollment by the investigator; 8. Clinically significant pleural effusion at screening; 9. History of epilepsy, cerebral ischemia\u002Fhemorrhage, cerebellar disease, or other active CNS diseases; 10. History of deep vein thrombosis or pulmonary embolism within 6 months before screening; 11. Known history of hypersensitivity to any component of the study drug; 12. Live vaccination within 6 weeks before screening; 13. Active infection at screening; 14. Expected lifespan less than 3 months; 15. Participation in another interventional clinical study within 3 months before screening involving investigational drugs not yet marketed, or within 5 half-lives for marketed drugs; or intention to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the study; 16. Other conditions deemed unsuitable for participation by the investigator.","65 Years",{"count":135,"type":20},11,[137],"NA","This is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of STR-P004 in subjects with relapsed\u002Frefractory CD19-positive acute lymphoblastic leukemia.",[28],[141,15],"STR-P004","2025-11-17",{"date":144,"type":39},"2025-11-24",{"date":146,"type":20},"2025-12-03",{"date":148,"type":20},"2026-12-30",{"name":150,"class":151},"Starna Therapeutics","INDUSTRY",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":15,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":47},"100596009","phase-2-efficacy-of-low-dose-venetoclax-with-itraconazole--tacl-for-rr-all-patients-100596009","NCT07039877","Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R\u002FR ALL Patients","Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed\u002FRefractory Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* B-cell or T-cell acute lymphoblastic leukemia.\n* Philadelphia chromosome negative\n* Relapsed disease after any line of treatment, defined as detection of disease activity at any time after remission\n* Refractory disease after first-line treatment, defined as: more than 5% blasts after completion of induction\u002Fconsolidation by flow cytometry\n* Not having included venetoclax in any prior regimen.\n* No prior organ damage, defined as the absence of any serious, life-threatening disease prior to the start of treatment.\n* Performance status defined by the ECOG scale between 0 and 2.\n\nExclusion Criteria:\n\n* Isolated CNS relapse.\n* Performance status defined by ECOG scale between 3 and 4.\n* CTCAE-classified sensory or motor neuropathy of grade 3 or higher.\n* History of hypersensitivity or intolerance to the drugs included in the regimen.\n* Prior organ damage, defined as the presence of any serious, life-threatening illness prior to the start of treatment.","16 Years","45 Years",{"count":162,"type":20},12,[24],"Relapsed\u002Frefractory acute lymphoblastic leukemia remains a challenge in the context of limited access to immunotherapy in developing countries. With such poor 5-year overall survival rates of 10%, the investigators need strategies that surpass the complete response rate achieved in this setting, which does not exceed 60% effectiveness with different regimens, and to eventually transfer patients to hematopoietic stem cell transplantation.\n\nIn this context, the investigators are studyng if the use of venetoclax, a BCL2 inhibitor, with the use of a cytochrome p450 inhibitor such as itraconazole, alongside the TACL chemotherapy regimen, which is based on the combination of asparaginase, dexamethasone, bortezomib, vincristine, and mitoxantrone.",[28,166,167],"Acute Lymphoblastic Leukaemia Recurrent","Philadelphia Chromosome Negative ALL",[15,169,170,171,172],"relapsed ALL","Venetoclax","TACL","refractoy ALL","2025-09-29",{"date":175,"type":39},"2025-10-02",{"date":177,"type":39},"2025-01-02",{"date":179,"type":20},"2026-04-30",{"name":181,"class":71},"Hospital Universitario Dr. Jose E. Gonzalez",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":15,"minAge":80,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":47},"100605442","phase-1-this-is-a-phase-iii-interventional-open-label-treatment-study-designed-to-evaluate-the-safety-and-efficacy-of-anti-cd-1922-car--t-cells-immunotherapy-for-adults-with-relapsed-or-refractory-acute-lymphoblastic-leukemialymphoma-100605442","NCT07162571","This is a Phase I\u002FII Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19\u002F22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia\u002FLymphoma.","Phase I\u002FII Open-label Study Evaluating The Safety And Efficacy of Anti CD19\u002F22 CAR-T Cells Therapy Adults With R\u002F R Leukemia\u002F Lymphoma","MSTH-CAR002","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years.\n2. Willing and able to give written, informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.\n4. Relapsed or refractory lymphoblastic leukemia\u002Flymphoma.\n\n   \\- Chemotherapy-refractory disease after ≥1 lines of therapy\n\n   \\- Relapse after chemotherapy or after ASCT\u002FAllo-HSCT.\n5. Adequate organ system function including - Creatinine clearance ≥40 cc\u002Fmin.\n\n   \\- Serum alanine aminotransferase \u002F aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).\n\n   \\- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.\n\n   \\- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \\[ECHO\\] or\n\n   \\- Baseline oxygen saturation \\>92% on room air and ≤Grade 1 dyspnoea.\n6. Have no active GVHD (Grade 2-4)\n7. Adequate bone marrow (BM) function - Absolute neutrophil count ≥1.0 × 10\\^9\u002FL.\n\n   * Absolute lymphocyte count ≥0.3 × 10\\^9\u002FL (at enrolment and prior to leukapheresis).\n   * Haemoglobin ≥80 g\u002FL.\n   * Platelets ≥75 × 10\\^9\u002FL\n\n7\\. The expression of CD19 and\u002For CD22 on the tumor cells are reported as positive by either immunohistochemistry or flow cytometry\n\nExclusion Criteria:\n\n1. Females who are pregnant or lactating.\n2. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.\n3. Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).\n4. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.\n5. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.\n6. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 24 months.\n\n6\\. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.\n\n7\\. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).\n\n8\\. The following medications are excluded:\n\n* Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted.\n* Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion.\n* Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis.\n* Antibody therapy use including anti-CD20\u002F19\u002F22 therapy within 2 weeks prior to CAR-T cells infusion.\n* Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis.\n* Live vaccine ≤4 weeks prior to enrolment.\n* Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.\n\nPrior limited radiation therapy within 2 weeks of CAR-T cells infusion. 9. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine or tocilizumab.\n\n10\\. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.",{"count":191,"type":20},17,[23,24],"The purpose of this study is to estimate the safety and the efficacy of anti-CD19\u002F22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia\u002Flymphoma.",[28,195],"B Cell Lymphoma",[197,28,198,199],"CD19\u002F22 CAR-T cells","B Cell lymphoma","dual targeting CAR-T therapy","2025-09-06",{"date":202,"type":39},"2025-09-09",{"date":204,"type":20},"2026-01-01",{"date":206,"type":20},"2031-12",{"name":208,"class":46},"Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology"]