[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-b-cell-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-b-cell-non-hodgkin-lymphoma":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,65,93,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100590674","phase-1-a-clinical-trial-of-b019-injection-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkins-lymphoma-100590674",false,"NCT06970496","A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.","A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.","Inclusion Criteria:\n\n1. Subjects who can fully understand this trial and voluntarily sign the informed consent form (ICF) before any research-related procedures;\n2. Histologically confirmed B-cell non-Hodgkin's lymphoma (B-NHL) with specified pathological subtypes;\n3. Histologically confirmed CD19 and\u002For CD22 positivity;\n4. Expected survival time exceeding 12 weeks;\n5. ECOG performance status 0-1 (Ia) or 0-2 (Ib);\n6. At least one measurable lesion in two dimensions according to the Lugano 2014 criteria;\n7. Bone marrow, liver, kidney, and cardiac-pulmonary functions meeting the specified requirements; 8 Subjects who were evaluated by the researchers as tolerant to the collection of peripheral blood mononuclear cells (PBMC); 9 Subjects who were evaluated by the researchers as having no contraindications for lymphodepleting chemotherapy.\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma; However, secondary CNS lymphoma without clinical symptoms can be enrolled after being determined by the researchers；\n2. Use of the prescribed drugs or treatments within the specified time before the collection of PBMC;\n3. Prior allogeneic hematopoietic stem cell transplantation;\n4. Systemic intravenous infusion treatment or uncontrollable bacterial, fungal or viral infection within 2 weeks before signing the ICF;\n5. A history of deep vein thrombosis or pulmonary embolism or anticoagulant therapy within 6 months before signing the ICF;\n6. A clinically significant history of severe heart disease within 6 months before signing the ICF;\n7. Terminal organ damage or autoimmune diseases requiring systemic immunosuppressive\u002Fsystemic treatments within 2 years before signing the ICF; Or have graft-versus-host disease;\n8. Prescribed malignant tumors within 5 years before signing the ICF;\n9. Intestinal obstruction caused by tumor compression or vascular compression requiring emergency treatment; gastrointestinal involvement with a risk of bleeding assessed by the researchers;\n10. Clinically significant CNS diseases in the past or at the time of screening;\n11. A history of severe allergic reactions to the drugs or excipients that were definitely needed in this study. Or have a history of allergic reactions to tocilizumab;\n12. Any indwelling tubes or drainage tubes in the bodies, the use of dedicated central venous access catheters is permitted;\n13. Pregnant or breastfeeding women; or male or female subjects who are unwilling to use contraception from the time of signing the ICF until 1 year after receiving B019 injection cell infusion or until CAR is detectable in peripheral blood.;\n14. The subjects who have participated in other clinical studies within the past 1 month, or whose last medication use for the last clinical study is still within the 5 half-life periods of the current drug at the time of screening;\n15. Other circumstances that the researchers consider unsuitable for participating in this study.","ALL","18 Years","70 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of the study is to evaluate the safety、tolerability and preliminary efficacy of B019 in subjects with relapsed or refractory B-cell non-Hodgkin's lymphoma.",[27],"Relapsed or Refractory B Cell Non Hodgkin Lymphoma","NOT_YET_RECRUITING","2026-08-13",{"date":31,"type":32},"2026-08-14","ACTUAL",{"date":34,"type":21},"2026-08-31",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.","INDUSTRY",7,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100559558","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-yk012-100559558","NCT06565689","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012","A Multi-center, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits.\n2. Males or females aged ≥ 18 to ≤ 65 years.\n3. Participants with an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1.\n4. Participants with an estimated survival time of more than 12 weeks.\n5. Participants with relapsed or refractory B-NHL. These patients' disease history must meet the following World Health Organization (WHO) diagnostic subtypes of B-NHL : follicular lymphoma (FL), MALT lymphoma, lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), grey zone lymphoma, Burkitt lymphoma.\n6. Participants have previously received rituximab Treatment (unless rituximab is intolerant) and at least second-line therapy.\n7. Participants with at least one evaluable tumor lesion per the Lugano 2014 criteria, i.e., a lymph node lesion \\> 15 mm in long diameter or an extranodal lesion \\> 10 mm in long diameter according to computed tomography (CT) cross-sectional imaging.\n8. Adverse reactions caused by previous treatment have recovered to below level 1 assessed by NCI CTCAE v5.0 before screening (except hair loss).\n9. Participants with essentially normal function of hematology, liver, and kidney function.\n10. Female participants of childbearing potential must have a negative blood pregnancy test and agree to use reliable methods of contraception (hormonal or barrier methods or sexual abstinence) with their partner throughout the study period and until 3 months after the last dose.\n11. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Participants who meet any of the following exclusion criteria will not be included in this study:\n\n   Treatment with biologic targeted therapy or anti-tumor immunotherapy within 4 weeks prior to the first dose of YK012; Participants who have received chemotherapy within 4 weeks prior to the first dose of YK012; Participants who have received small molecule targeted agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of YK012; Participants who have received other investigational agents within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of YK012; Participants who have received radical\u002Fextensive radiotherapy within 4 weeks prior to the first dose of YK012, or local palliative radiotherapy within 2 weeks prior to the first dose of YK012, or acute toxicity induced by previous radiotherapy have not recovered to grade ≤1; Participants who have received autologous HSCT within 12 weeks prior to the first dose of YK012; Participants who have received allogeneic HSCT or organ transplant; Participants who have received chimeric antigen receptor T cell (CAR-T) immunotherapy.\n2. History of malignancy other than B-cell NHL within 5 years prior to study entry, except for local cancers that have been clearly cured or have been free of disease for at least 5 consecutive years.\n3. Participants with clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the Investigator.\n4. a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; b) Evidence for presence of inflammatory lesions and\u002For vasculitis on cerebral MRI.\n5. Participants with a history or evidence of serious cardiovascular disease, including but not limited to:\n\n   Acute coronary; Coronary angioplasty or stent implantation within 6 months prior to first dose of YK012; Clinically significant unstable arrhythmias (e.g., atrial fibrillation) , however, whose atrial fibrillation have been controlled for over 30 days prior to the first dose of YK012 were allowed to be enrolled; Severe cardiac rhythm abnormalities; Grade III or higher congestive heart failure as defined by the New York Heart Association (NYHA) standards; Cardiac valve morphological abnormalities recorded by ECHO (≥ grade 2), those participants with grade 1 cardiac valve morphological abnormalities (such as mild regurgitation\u002Fstenosis) were allowed to be enrolled, but participants with moderate valve thickening were excluded; Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\\\u003C50% if there is no lower limit at the research center; QTcF ≥ 470 msec (female) or ≥ 450 msec (male)； Implantable defibrillator; Participants with clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and\u002For DBP≥100 mm Hg).\n6. Known allergy to monoclonal antibody drugs or immunoglobulin.\n7. Participants who have undergone any major organ surgery or significant trauma within 4 weeks prior to the first dose of YK012, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered before the first dose of the YK012.\n8. Regular dose of systemic corticosteroids during the 4 weeks prior to initiation of study drug or anticipated need of corticosteroids exceeding prednisone 20 mg\u002Fday or equivalent during the trial, or any other systemic immunosuppressive therapy within 4 weeks prior to study entry.\n9. The results of serological testing for the virus are clinically significant as judged by the investigator.\n10. Participants with uncontrolled active infections currently require systemic anti-infective therapy, except for local treatment.\n11. Participants with uncontrollable space effusion (e.g. pleural effusion, abdominal effusion, pericardial effusion, etc.), as judged by the Investigator.\n12. Pregnant or lactating women.\n13. Participants with mental disorders or poor protocol compliance.\n14. Participants who have used live attenuated vaccines within 4 weeks prior to the first dose of YK012.\n15. Participants with any other condition or circumstance that would, in the discretion of the Investigator, make the subject unsuitable for participation in this clinical study.","65 Years",{"count":20,"type":21},[24],"This study aims to provide a basis for further clinical development of YK012.",[53],"Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","RECRUITING","2026-07-16",{"date":57,"type":32},"2026-07-17",{"date":59,"type":32},"2023-05-09",{"date":61,"type":21},"2028-12",{"name":63,"class":39},"Excyte Biopharma Ltd",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":90,"locationsCount":64},"100646121","real-world-study-of-bispecific-antibody-in-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-100646121","NCT07695896","Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age \\>= 18 years at the start of treatment\n* Histologically confirmed B-cell non-Hodgkin lymphoma\n* Relapsed or refractory disease after at least one prior line of systemic therapy\n* Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation\n* Signed informed consent for the investigational treatment\n\nExclusion Criteria:\n\n* Currently participating in, or planning to participate in, any interventional clinical trial\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study",{"count":73,"type":21},200,"OBSERVATIONAL","B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R\u002FR). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population.\n\nThis is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).",[53],[78,79,80,81,82,83],"B-cell non-Hodgkin lymphoma","Bispecific antibody","Glofitamab","CD20xCD3","Real-world study","Relapsed refractory","2026-07-06",{"date":86,"type":32},"2026-07-10",{"date":88,"type":21},"2026-07",{"date":61,"type":21},{"name":91,"class":92},"Yanyan Liu","OTHER_GOV",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100530638","phase-1-a-study-to-evaluate-mk-1045-cn201-in-participants-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-mk-1045-001cn201-101-100530638","NCT06189391","A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001\u002FCN201-101)","An Open-Label, Dose Escalation Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-1045 (CN201) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion\u002FExclusion Criteria:\n\nInclusion Criteria\n\nInclusion Criteria include, but are not limited to:\n\n* Has relapsed or refractory B-cell Non-Hodgkin's lymphoma (B-NHL) with disease history meeting the following World Health Organization (WHO) diagnostic subtypes of B-NHL that are CD19-positive in pathologic immunohistochemistry test: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) (Grade I to III), marginal zone lymphoma, lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocytic lymphoma, and transformed large B-cell lymphoma (During the dose-escalation phase, participants, excluding those treated with Chimeric antigen receptor T-cell (CAR-T) who cannot provide proof of pathologic immunohistochemistry CD19 positivity but have previous proof of CD20 positivity may be considered for enrollment after communication with the sponsor)\n\n  * Relapse is defined as the occurrence of progressive disease (PD) after complete response (CR) or partial response (PR) has been achieved after adequate treatment. Note: For DLBCL participants, relapse must occur after participants undergoing at least two lines of therapy; for other participants, they must undergo at least one line of therapy.\n  * Refractory is defined as a situation that there is no standard of care available or that it is not applicable to use standard of care at this stage, including: Participants who are unresponsive to standard of care (e.g., monotherapy or combination therapy containing anti-CD20 monoclonal antibody) and whose best response to standard therapy is PD or stable disease (SD); Participants who are not eligible for autologous hematopoietic stem cell transplantation (ASCT) and have relapsed PD after receiving ASCT; Participants who have failed on chimeric antigen receptor T cell (CAR-T) immunotherapy, but the first dose of the study intervention must be at least 3 months after discontinuation of CAR-T therapy, and CD19 positive expression is still present in tumor tissue.\n* Has at least one evaluable tumor lesion per the Lugano 2014 criteria, i.e., a lymph node lesion \\> 15 mm in long diameter or an extranodal lesion \\> 10 mm in long diameter according to computed tomography (CT) cross-sectional imaging or magnetic resonance imaging (MRI)\n* Has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2 and an estimated survival time of more than 3 months\n* Has essentially normal: bone marrow function; coagulation function; liver function; kidney function; lung function; and heart function\n\nExclusion Criteria\n\nExclusion Criteria include, but are not limited to:\n\n* Has any other non-Hodgkin lymphoma (NHL) not listed in inclusion criteria\n* Has been treated with anti-CD3\u002FCD19 bispecific antibody (BsAb) prior to first dose of study intervention\n* Has received chemotherapy, endocrine therapy, radiotherapy (palliative radiotherapy 2 weeks prior to the first administration of the investigational drug), or biologic therapy, and small molecule targeted agents within 2 weeks prior to the first administration of the investigational drug or within 5 half-lives of the drug, whichever is shorter\n* Has received anti-CD20 antibody or anti-CD19 antibody within 4 weeks prior to first use of the investigational drug\n* Has received anti-tumor immunotherapy or other unlisted clinical study intervention within 4 weeks prior to the first dose of study intervention, or within 5 half-lives of the drug, whichever is shorter\n* Has undergone any major organ surgery (excluding aspiration biopsy) or significant trauma within 4 weeks prior to the first dose of study intervention or those requiring elective surgeries during the study\n* Has received systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study intervention, excluding the following agents: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, and short-term, prophylactic use of corticosteroids (e.g. to prevent radio contrast agent induced allergic reactions)\n* Has used immunomodulatory agents, including but not limited to thymosin, interleukin-2 (IL-2), interferon (IFN) and anti-tumor Chinese patent drugs or Chinese herbal medicines within 14 days prior to the first dose of study intervention\n* Has had a live attenuated vaccines within 4 weeks prior to the first dose of study intervention\n* Has a central nervous system (CNS) infiltration\n* Has previous or concomitant CNS diseases, including epilepsy, severe brain injury, dementia, Parkinson's disease, cerebellar disorder, organic cerebellar syndrome, or mental diseases\n* Has prior or concomitant malignancies (except cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, prostatic intraepithelial neoplasia, and other tumors that have been clinically cured for 5 years as assessed by the investigator)\n* Has uncontrolled active infections currently requiring systemic anti-infective therapy within 3 days prior to first dose\n* Has active hepatitis B and\u002For hepatitis C. Participants who are positive for antibodies to hepatitis C virus (HCV). Participants who are hepatitis B surface antigen (HBsAg) positive are not allowed to enroll in the dose-escalation period; however, those who were hepatitis B surface antigen (HBsAg)-positive but hepatitis B Virus deoxyribonucleic acid (HBV DNA)-negative and adherent to entecavir antiviral therapy and who agreed to regular monthly monitoring of HBV DNA are allowed to enroll in the dose-expansion period\n* Has a history of immunodeficiency, including testing positive for human immunodeficiency virus (HIV) antibody\n* Has a history of serious cardiovascular and cerebrovascular disease, including but not limited to: severe cardiac rhythm or conduction abnormalities; acute coronary syndrome, congestive heart failure, stroke, or other Grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to the first dose; ≥ Class II cardiac function as per New York Heart Association (NYHA) functional class or LVEF \\\u003C 50%; or clinically uncontrollable hypertension\n* Has previous or current interstitial lung disease\n* Has acute graft-versus-host disease (GVHD) or active chronic GVHD at present\n* Has active or history of autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) that may relapse, or participants who are at risks (e.g., organ transplant requiring immunosuppressive therapy). Participants with the following diseases are allowed to be further screened for enrollment: hypothyroidism managed with hormone replacement therapy only, and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia).\n* Has received immunotherapy with known Grade 3 or higher immune-related adverse events (irAEs)\n* Has non-hematologic adverse reactions from prior anti-tumor therapy have not recovered to Grade ≤ 1 as assessed by National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (excluding toxicities such as alopecia that are assessed by the investigator to have no safety risk)","75 Years",{"count":102,"type":21},100,[24],"Researchers are looking for new ways to treat people with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). B-cells are a type of white blood cells that make antibodies and help fight infections. Non-Hodgkin Lymphoma is a type of cancer in the lymphatic system causing enlarged lymph nodes and\u002For organs in belly or chest. Relapsed means a disease or condition comes back after treatment Refractory means a disease does not respond to treatment or stops responding to a treatment.\n\nMK-1045, the study medicine, is designed to treat relapsed or refractory B-NHL. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer.\n\nThis is the first study in which MK-1045 will be given to people. The goal of this study is to learn about:\n\n* The safety of MK-1045 and how well people tolerate it.\n* The highest dose of MK-1045 that is well tolerated.\n* How well MK-1045 works to treat relapsed or refractory B-NHL.",[53],"2026-06-24",{"date":108,"type":32},"2026-06-26",{"date":110,"type":32},"2021-03-16",{"date":112,"type":21},"2029-03-30",{"name":114,"class":39},"MSD R&D (China) Co., Ltd.",15,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":17,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100529418","phase-1-a-study-of-cd19-targeted-car-t-cell-therapy-in-pediatric-patients-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-b-all-and-aggressive-mature-b-cell-non-hodgkin-lymphoma-b-nhl-100529418","NCT06173518","A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)","A Single-Arm, Open-Label, Multicenter, Phase 1b\u002F2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed\u002FRefractory (R\u002FR) B Cell Acute Lymphoblastic Leukemia (B ALL) or R\u002FR Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).","INCLUSION CRITERIA:\n\n* \\\u003C 18 years old at screening\n* ≥ 6 kg body weight at screening\n\nPediatric patients with r\u002Fr B ALL\n\nr\u002Fr CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified).\n\n* Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10 year) performance status score ≥ 50%.\n* In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent.\n* Adequate renal, hepatic, pulmonary, and cardiac function.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis.\n* History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia.\n* Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.\n* Received prior (\\\u003C 3 months before obe cel infusion) stem cell transplantation.\n* Prior CD19 targeted therapy other than blinatumomab.\n* Experienced Grade ≥ 3 neurotoxicity following blinatumomab.","0 Years",{"count":125,"type":21},30,[24],"This is a Phase 1b\u002F2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r\u002Fr) B cell acute lymphoblastic leukemia (B ALL) and r\u002Fr B cell Non-Hodgkin lymphoma (B NHL).",[129,130],"Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia","Relapsed or Refractory B Cell Non-Hodgkin Lymphoma",[132,133,134,135,136,137,138,139,140,141,142,143],"B cell acute lymphoblastic leukemia","B cell Non-Hodgkin lymphoma","Relapsed B cell acute lymphoblastic leukemia","Relapsed B cell Non-Hodgkin lymphoma","Refractory B cell acute lymphoblastic leukemia","Refractory B cell Non-Hodgkin lymphoma","Aggressive mature B cell Non-Hodgkin lymphoma","Pediatric ALL","Pediatric NHL","Obecabtagene autoleucel","CD19-positive CAR T cell","Obe-cel","2026-02-26",{"date":146,"type":32},"2026-03-02",{"date":148,"type":32},"2023-11-16",{"date":150,"type":21},"2027-11",{"name":152,"class":39},"Autolus Limited",8]