[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-b-cell-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-b-cell-non-hodgkin-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,68,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100437025","phase-1-a-study-to-evaluate-the-safety-and-anti-cancer-activity-of-loncastuximab-tesirine-in-combination-with-other-anti-cancer-agents-in-participants-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-lotis-7-100437025",false,"NCT04970901","A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)","A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)","Inclusion Criteria:\n\n* Male or female participant aged 18 years or older\n* Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-NHL (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens in Part 1; and at least one systemic treatment regimen in Part 2\n\n  * LBCL:\n\nPart 2 Arm E enrollment focused on LBCL only\n\n* DLBCL, not otherwise specified (NOS)\n* Germinal Center B-cell type\n* Activated B-cell type\n* Transformed FL (note: patients with transformed FL must have received at least one line of systemic therapy post-transformation to be eligible)\n* HGBCL, with MYC and BCL2 and\u002For BCL6 rearrangements\n* HGBCL, NOS\n* FL Grade 3b\n\n  * Arm F and Part 1 Arm E:\n* All LBCL histologies listed above\n* FL (Grade 1-3a)\n* MZL\n\n  * For Arm C only:\n* All histologies listed above\n* DLBCL (including transformed diseases)\n* MCL\n* BL\n\n  * Life expectancy of at least 24 weeks according to Investigator's judgement\n  * Need of systemic treatment for any of the listed indications as assessed by the investigator, including indolent B-NHLs (e.g. FL and MZL)\n  * Measurable disease as defined by the 2014 Lugano Classification\n  * Availability of formalin-fixed paraffin-embedded tumor tissue block\n  * ECOG performance status 0 to 2\n  * Adequate organ function\n  * Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent the first dose until at least 7 months after the last dose of loncastuximab tesirine. Men must refrain from donating sperm during this same period. Arm E: WOCBP must agree to use contraceptive methods that result in a failure of less than 1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 18 months after pretreatment with obinutuzumab. Arm F: WOCBP must agree to use contraceptive methods that result in a failure of less than 1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable)\n  * Patients 80 years of age and older at the time of signing the informed consent must be deemed fit by Cumulative Illness Rating Scale - Geriatric (CIRS-G scale), defined as no score of 3-4 in any category AND \\\u003C 5 categories with a score of 2 excluding hematologic criteria\n\nExclusion Criteria:\n\n* Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human ADA to a CD19 antibody\n* Previous therapy with loncastuximab tesirine\n* Previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab (applied to relevant arm and\u002For cohort of the specific drug administered)\n\n  * Participants who received previous treatment of polatuzumab vedotin containing regimen will be excluded from Arm C\n  * Participants who received previous treatment of glofitamab containing regimen will be excluded from Arm E\n  * Participants who received previous treatment of mosunetuzumab containing regimen will be excluded from Arm F\n* Human immunodeficiency virus (HIV) seropositive\n* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load\n* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load\n* History of confirmed progressive multifocal leukoencephalopathy\n* History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or macrophage activation syndrome (MAS)\u002Fhemophagocytic lymphohistiocytosis (HLH)\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)\n* Breastfeeding or pregnant\n* Significant medical comorbidities\n* Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drugs (C1 D1), unless approved by the Sponsor\n* Live vaccine within 4 weeks prior to C1D1\n* Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) from acute non-hematologic toxicity (excluding alopecia) due to previous therapy prior to screening\n* Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary\n\nExtra Exclusion Criteria for Arms E (includes glofitamab) and F (includes mosunetuzumab) Note: as applicable, the arm-specific exclusion criteria may supersede the general ones, such as stem cell transplant.\n\n* Prior allogeneic stem cell transplant and solid organ transplant\n* Autologous stem cell transplant within 100 days prior to C1D1\n* History of central nervous system (CNS) lymphoma or leptomeningeal infiltration\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Known active infection, reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within four weeks prior to C1D1\n* Active or history of autoimmune disease or immune deficiency, motor neuropathy considered of autoimmune origin and other CNS autoimmune diseases, including but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with, with certain exceptions\n* Prior treatment with anti-cancer\u002Flymphoma targeted therapies (e.g., tyrosine kinase inhibitors, systemic immunotherapeutic\u002Fimmunostimulating agents, including, but not limited to, cluster of differentiation 137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death protein 1 (PD1), and anti-programmed death ligand 1 (PDL1) therapeutic antibodies, radio-immunoconjugates, ADCs, immune\u002Fcytokines and monoclonal antibodies) or treatment with systemic immunosuppressive medication (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to C1D1, or anticipation of need for systemic immunosuppressive medication during study treatment, with certain exceptions\n* Prior treatment with CAR-T-cell therapy within 100 days prior to C1D1; primary refractory patients (progressive or persistent disease within 30 days) to CAR-T-cell therapy are not eligible\n* Toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 with the exception of alopecia, endocrinopathy managed with replacement therapy and stable vitiligo\n* Any history of immune-related Grade ≥3 AE with the exception of endocrinopathy managed with replacement therapy\n* Ongoing corticosteroid use greater than 25 mg\u002Fday of prednisone or equivalent within 4 weeks prior and during study treatment\n* Administration of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment\n* Arm E only: Known history of hypersensitivity to obinutuzumab","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE) for the combinations.",[26,27,28],"B-Cell Non-Hodgkin Lymphoma","Relapsed B-Cell Non-Hodgkin Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma",[26,27,28,30],"Loncastuximab Tesirine","RECRUITING","2026-06-07",{"date":34,"type":35},"2026-06-09","ACTUAL",{"date":37,"type":35},"2022-06-17",{"date":39,"type":20},"2027-10-29",{"name":41,"class":42},"ADC Therapeutics S.A.","INDUSTRY",42,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100602619","phase-2-study-of-relapsed-refractory-b-cell-non--hodgkin-lymphoma-100602619","NCT07125872","Study of Relapsed\u002F Refractory B-cell Non- Hodgkin Lymphoma","Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination With Rituximab in Participants With Relapsed\u002F Refractory B-cell Non- Hodgkin Lymphoma","Inclusion Criteria:\n\n* 1- Age\\>18 years old 2- Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee( HRECC) or independent Ethics Committee( IEC) guidelines 3. Histologically or flow cytometry documented B-cell NHL, (excluding primary central nervous system \\[CNS\\] lymphoma, chronic lymphocytic leukemia \\[CLL\\], and Burkitt lymphoma) with the following specific criteria:\n\n  * Have completed ≥2 lines of cytotoxic chemotherapy.\n  * Have received rituximab or another anti-CD20 antibody.\n  * Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \\>15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis, or bone marrow involvement that is biopsy proven.\n\n    4\\. Eastern Cooperative Oncology Group (ECOG) performance status (Appendix 5) of 0 to 1.\n\n    5\\. Stated willingness to comply with study procedures. 6. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n\n    7\\. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 30 days after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) and implants such as intrauterine devices (IUDs).\n\nExclusion Criteria:\n\n* Participants with ANY of the following criteria are excluded from participation in the study:\n\n  1. Histologically documented primary CNS lymphoma, CLL, Burkitt, Burkitt-like lymphoma.\n  2. Known hypersensitivity or allergy to any component of the study medications, including sulfa-containing study medication(s) (e.g., albumin \\[human\\], dimethyl sulfoxide \\[DMSO\\]).\n  3. Inadequate organ function, evidenced by the following laboratory results:\n\n     1. ANC \\\u003C 1000 cells\u002Fmm3.\n     2. Platelet count \\\u003C 100,000 cells\u002Fmm3.\n     3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).\n     4. Aspartate aminotransferase (AST \\[SGOT\\])\u002FALT (SGPT) ≥ 2.5 × ULN.\n     5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).\n     6. Serum creatinine ≥ 160 µmol\u002FL. NOTE: Each study site should use its institutional ULN to determine eligibility.\n  4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications.\n  5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n  6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n  7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.\n  8. History of receiving allograft organ transplant requiring immunosuppression.\n  9. Participants post solid organ transplants who develop high grade lymphomas or leukemias.\n  10. Metastases to the CNS, including parenchyma or leptomeninges.\n  11. Nonmalignant CNS disease (e.g., stroke, epilepsy, vasculitis, or neurodegenerative disease).\n  12. History of active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n  13. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (i.e., active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association (Appendix 6) Class 2 or higher; or serious cardiac arrhythmia requiring medication.\n  14. Current chronic daily treatment (continuous for \\>3 months) with systemiccorticosteroids as defined as \\>20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n  15. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n  16. Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test.\n  17. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and a detectable HIV viral load.\n  18. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n  19. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n  20. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n  21. Women who are pregnant or breastfeeding.",{"count":52,"type":20},20,[54],"PHASE2","Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed\u002F Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.",[57],"Relapsed B-Cell Non Hodgkin Lymphoma","2026-04-28",{"date":60,"type":35},"2026-05-04",{"date":62,"type":35},"2025-11-11",{"date":64,"type":20},"2028-05-25",{"name":66,"class":42},"ImmunityBio, Inc.",2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100629645","phase-2-study-of-cd19-t-hank-and-nai-with-rituximab-in-participants-with-indolent-non-hodgkin-lymphoma-100629645","NCT07477366","Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma","Open-Label, Phase 2 Chemotherapy-Free Study of CD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed\u002FRefractory B-Cell Indolent Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 to ≤ 75 years old.\n2. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Histologically or flow cytometry documented relapsed\u002Frefractory B-cell indolent NHL (iNHL) including but not limited to follicular lymphoma \\[FL\\]; lymphoplasmacytic lymphoma \\[LPL\\], also known as Waldenstrom macroglobulinemia \\[WM\\]; marginal zone lymphoma \\[MZL\\] with the following specific criteria:\n\n   1. Have completed ≥ 2 lines of cytotoxic chemotherapy.\n   2. Have received rituximab or another anti-CD20 antibody.\n   3. Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \\> 15 mm in the long axis or extranodal lesions \\> 10 mm in long and short axis, or bone marrow involvement that is biopsy proven.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n5. Stated willingness to comply with study procedures.\n6. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n7. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative pregnancy test and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive, or an intrauterine device \\[IUD\\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 12 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 12 months post last dose of study drug).\n\nExclusion Criteria:\n\n1. Histologically documented large B-cell lymphomas (eg, diffuse large B-cell lymphoma \\[DLBCL\\], anaplastic large cell lymphoma \\[ALCL\\], follicular large cell lymphoma, mantle cell lymphoma), primary central nervous system (CNS) lymphoma, chronic lymphocytic leukemia (CLL), Burkitt and Burkitt-like lymphoma.\n2. Known hypersensitivity or allergy to any component of the study medications, including sulfa containing study medication(s) (eg, albumin \\[human\\], dimethyl sulfoxide \\[DMSO\\]).\n3. Inadequate organ function, evidenced by the following laboratory results:\n\n   1. ANC \\\u003C 1000 cells\u002Fmm3.\n   2. Platelet count \\\u003C 100,000 cells\u002Fmm3.\n   3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).\n   4. Aspartate aminotransferase (AST \u002FALT ≥ 2.5 × ULN.\n   5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).\n   6. Serum creatinine ≥ 2 mg\u002FdL. NOTE: Each study site should use its institutional ULN to determine eligibility\n4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications.\n5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n6. History of allogeneic hematopoietic stem cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.\n8. History of receiving allograft organ transplant requiring immunosuppression.\n9. Participants that underwent a solid organ transplant who develop high grade lymphomas or leukemias.\n10. Metastases to the CNS, including the parenchyma or leptomeninges.\n11. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).\n12. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n13. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.\n14. Current chronic daily treatment (continuous for \\> 3 months) with systemic corticosteroids as defined as \\> 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n15. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n16. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and\u002For a detectable HIV viral load.\n17. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n18. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n19. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n20. Women who are pregnant or breastfeeding.","75 Years",{"count":52,"type":20},[54],"Open-Label, Phase 2 Chemotherapy-Free Study ofCD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed\u002FRefractory B-Cell Indolent Non-Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.",[27],"NOT_YET_RECRUITING","2026-03-13",{"date":83,"type":35},"2026-03-17",{"date":85,"type":20},"2026-04",{"date":87,"type":20},"2028-12",{"name":66,"class":42},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100540216","phase-1-a-study-of-lucar-20sp-in-subjects-with-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100540216","NCT06313957","A Study of LUCAR-20SP in Subjects With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Subjects voluntarily participate in clinical research;\n* Age ≥18 years old;\n* Eastern Cooperative Oncology Group (ECOG) score 0-1;\n* Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;\n* At least one measurable tumor lesion according to the Lugano 2014.\n* Expected survival ≥3 months;\n* Clinical laboratory values in the screening period meet criteria.\n* Effective contraception.\n\nExclusion Criteria:\n\n* Prior antitumor therapy with insufficient washout period.\n* Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection;\n* Previously received allogeneic hematopoietic stem cell transplantation;\n* Previously received gene therapy;\n* Donor specific antibody (DSA) positive subjects will be excluded;\n* Severe underlying diseases;\n* Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive;\n* Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.",{"count":43,"type":20},[23],"This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed\u002Frefractory B-cell non-Hodgkin lymphoma.",[100,101],"Relapsed B-cell Non-Hodgkin Lymphoma","Refractory B-cell Non-Hodgkin Lymphoma",[103,104],"Relapsed B-cell non-Hodgkin lymphoma","Refractory B-cell non-Hodgkin lymphoma","2025-03-20",{"date":107,"type":35},"2025-03-25",{"date":109,"type":35},"2024-03-14",{"date":111,"type":20},"2028-09",{"name":113,"class":114},"Peking University Cancer Hospital & Institute","OTHER",3]