[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,66,104,126],{"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},"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",false,"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)","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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.",[27],"Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","RECRUITING","2026-06-24",{"date":31,"type":32},"2026-06-26","ACTUAL",{"date":34,"type":32},"2021-03-16",{"date":36,"type":21},"2029-03-30",{"name":38,"class":39},"MSD R&D (China) Co., Ltd.","INDUSTRY",15,{"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":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100590674","phase-1-a-clinical-trial-of-b019-injection-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkins-lymphoma-100590674","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.","70 Years",{"count":50,"type":21},48,[24],"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.",[54],"Relapsed or Refractory B Cell Non Hodgkin Lymphoma","NOT_YET_RECRUITING","2026-04-29",{"date":58,"type":32},"2026-05-05",{"date":60,"type":21},"2026-08-31",{"date":62,"type":21},"2027-12-31",{"name":64,"class":39},"Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.",7,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":73,"maxAge":17,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"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":75,"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).",[79,80],"Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia","Relapsed or Refractory B Cell Non-Hodgkin Lymphoma",[82,83,84,85,86,87,88,89,90,91,92,93],"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":96,"type":32},"2026-03-02",{"date":98,"type":32},"2023-11-16",{"date":100,"type":21},"2027-11",{"name":102,"class":39},"Autolus Limited",8,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"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":50,"type":21},[24],"This study aims to provide a basis for further clinical development of YK012.",[27],"2026-02-04",{"date":118,"type":32},"2026-02-05",{"date":120,"type":32},"2023-05-09",{"date":122,"type":21},"2026-12-31",{"name":124,"class":39},"Excyte Biopharma Ltd",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":125},"100539183","phase-2-pemigatinib-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphomas-100539183","NCT06300528","Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas","PERFORM: A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* ECOG Performance Status ≤ 2.\n* Histologically confirmed MCL or MZL, including EMZL\u002FMALT lymphoma, SMZL, and NMZL.\n\n  --Patients with gastric MALT lymphoma and those who are H. Pylori positive need to have failed a trial of H. Pylori eradication and are either ineligible, have refused, or have failed gastric radiation therapy.\n* Have received at least two prior lines of systemic therapy and do not have FDA approved available therapies or have refused them.\n* Prior autologous hematopoietic cell transplantation (auto-HCT) and CAR-T cell therapy are eligible.\n\n  * Patients with prior auto-HCT may be eligible if treatment completed after at least 3 months prior to first treatment\n  * Patients with CAR T-cell therapy may be eligible if treatment completed after at least 1 month prior to first treatment\n* Subject must have an indication for systemic treatment.\n* Radiographically measurable disease by computed tomography (CT) scan, defined as at least one lesion \\>1.5 cm in size or assessable disease in the opinion of the investigator.\n* Life expectancy \\>3 months, in the opinion of the investigator.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3 (≥1.0 x 10\\^9\u002FL) independent of G-CSF support (i.e., no G-CSF within the past 3 days), unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case ANC of 750 cells\u002Fmm3 (0.75 x 10\\^9\u002FL) is permissible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.\n    * Platelet count ≥ 75,000\u002Fmm3 (≥75 x 10\\^9\u002FL) independent of transfusion support (i.e., no transfusion within the past 3 days) unless there is documented bone marrow involvement in which case platelet count of 50,000 cells\u002Fmm3 (0.5 x 10\\^9\u002FL) is permissible. Patients must be responsive to transfusion support if given for thrombocytopenia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.\n    * Hemoglobin ≥ 8 g\u002FdL independent of transfusion support (i.e., no transfusion within the past 3 days) unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case hemoglobin of 7 g\u002FdL is permissible. Patients must be responsive to transfusion support if given for anemia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN). or \\\u003C2.5 x ULN with document liver involvement and\u002F or Gilbert's disease\n    * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN ----Subjects with liver involvement will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.\n    * Renal:\n\n      ----Estimated creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft-Gault formula.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    ---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n\n    ---Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n\n    ---Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.3.1.\n* Ability to swallow oral tablets.\n* Recovery to baseline or ≤ Grade 2 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy per the treating investigator.\n* Patients or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.\n\nExclusion Criteria:\n\n* Prior receipt of FGFR inhibitor.\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.\n* Concurrent anticancer therapy except as listed in section 6.7.2 for prostate and breast cancer.\n* Prior systemic anti-cancer therapy or any investigational therapy within the timeframes listed below:\n\n  * Cytotoxic chemotherapy within 4 weeks prior to treatment.\n  * Monoclonal antibody within 3 weeks prior to treatment\n  * BTK inhibitor within 2 weeks prior to treatment. ---Note: The wash out interval is based on the last day of the prior therapy to the start of the study drug (C1D1).\n* Prior radiotherapy within 4 weeks prior to the first dose of study treatment.\n\n  --Note: Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have radiation pneumonitis. A 2-week washout is permitted for palliative radiation to non-CNS disease.\n* Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.\n* Active second malignancy which is expected to impact study participation, in the opinion of the investigator.\n* Known CNS involvement.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  --Cardiovascular disorders:\n  * Congestive heart failure New York Heart Association Class III or IV or serious cardiac arrhythmias.\n  * Unstable angina pectoris or acute coronary syndrome within the past 2 months prior to study enrolment\n  * History of myocardial infarction (MI) within 3 months prior to enrollment.\n  * QTcF prolongation defined as a QTcF \\> 470 ms\n\n    * Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n    * Correction for underlying bundle branch block (BBB) allowed.\n    * Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker.\n    * Left ventricular ejection fraction \\\u003C 40% in the 12 months prior to study enrollment\n    * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], etc.)\n* Known HIV infection.\n* Active hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.\n\n  --Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with SMZL who have chronic HCV will need to have undergone antiviral treatment to participate.\n* History and\u002For current evidence of ectopic mineralization\u002Fcalcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage\u002Ftendon calcification.\n* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination\n* Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Moderate CYP3A4 inhibitors are not prohibited but should be avoided.\n* Subject with history of hypovitaminosis D requiring supraphysiologic dose (such as 50,000 IU of vitamin D3) to replenish the deficiency. Subjects receiving vitamin D food supplements are allowed.\n* Current evidence of clinically significant corneal (including but not limited to bullous\u002Fband keratopathy, corneal abrasion, inflammation\u002Fulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to macular\u002Fretinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.7.4. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.",{"count":134,"type":21},27,[136],"PHASE2","The purpose of this clinical trial is to learn if the study drug pemigatinib is effective in treating patients with relapsed or refractory B-cell non-Hodgkin lymphomas.",[139,140,141],"Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","2025-11-25",{"date":144,"type":32},"2025-12-03",{"date":146,"type":32},"2025-10-03",{"date":148,"type":21},"2030-12",{"name":150,"class":151},"University of Utah","OTHER"]