[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-lymphoma":72},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,48,92,125,138,160,190,220,260,292,315,335,366,388,412,437,468,507,527,558,578,600,622,646,667],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053834","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-sonrotoclax-plus-zanubrutinib-compared-with-placebo-plus-zanubrutinib-in-adults-with-relapsedrefractory-mantle-cell-lymphoma-celestial-rrmcl-100053834",false,"NCT06742996","A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed\u002FRefractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)","A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)\n* Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis\n* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator\n* Relapsed or refractory disease after the last line of therapy\n* Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)\n* Prior therapy with BTK degraders\n* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.\n* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug\n* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug\n* Known central nervous system involvement by lymphoma\n* Clinically significant cardiovascular disease\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed\u002Frefractory (R\u002FR) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.",[27,28],"Mantle Cell Lymphoma","B Cell Lymphoma",[30,31,32,33,34],"mantle cell lymphoma","MCL","relapsed\u002Frefractory mantle cell lymphoma","sonrotoclax","BGB-11417","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-03-05",{"date":43,"type":21},"2032-03-30",{"name":45,"class":46},"BeOne Medicines","INDUSTRY",155,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":62,"conditions":63,"keywords":75,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100473255","phase-1-cd19cd22-bicistronic-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-b-cell-malignancies-100473255","NCT05442515","CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Phase 1\u002F2 Dose Escalation Study of CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis\n\n  * Participant must:\n\n    * Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and\n    * Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and\n    * Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and\n    * Be unable to access (in a timely manner), ineligible for, or have relapsed\u002Ffailed after or not responded to a commercially available CD19 CAR T-cell construct; and\n  * Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.\n* CD22\u002FCD19 expression\n\n  * Cohorts A1b, B1b, C2b\n\n    * CD19 must be detected on \\>15% of the malignant cells by immunohistochemistry or \\> 80% by flow cytometry.\n    * CD22 positivity must be confirmed.\n  * Cohorts D1b, 2 B-ALL\n\n    * CD19 or CD22 positivity must be confirmed\n    * Age \\>= 3 years of age and \\\u003C=39 years of age at time of enrollment.\n    * Clinical Performance status: Participants \\>= 16 years of age: Karnofsky \\>= 50%; Participants \\\u003C 16 years of age: Lansky scale \\>= 50%.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 750\u002FmcL\\*\n  * platelets \\>= 50,000\u002FmcL\\*\n  * total bilirubin \\\u003C=2 X ULN (except in the case of participants with documented Gilbert's disease \\> 3x ULN)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=10 X institutional upper limit of normal\n  * creatinine \\\u003C= the maximum for age listed in the table below OR\n  * measured creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above the max listed below per age.\n\n    * Age (Years) \\\u003C= 5 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 0.8\n    * Age (Years) 6 to \\\u003C= 10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.0\n    * Age (Years) \\>10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.2\n\n      * a participant will not be excluded because of pancytopenia \\>= Grade 3 if it is due to underlying bone marrow involvement by leukemia\n* Central nervous system (CNS) Status\n* Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria\n* Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.\n* Participants who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding while on study therapy and until 1 month after the administration of CAR.\n* Cardiac function: Left ventricular ejection fraction \\>= 45% or fractional shortening \\>=28%\n* Pulmonary Function\n\n  * Baseline oxygen saturation \\>92% on room air at rest\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following criteria are not eligible for participation in the study:\n\n* Participants with CNS3 disease, progressing neurologic signs\\* of CNS disease, radiologically detected active CNS lymphoma (\\*resolving manifestation or persistent and\u002For irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)\n* Hyperleukocytosis (\\>= 50,000 blasts\u002FmicroL)\n* Positive serum or urine beta-HCG pregnancy test performed at screening.\n* Participants will be excluded based on prior therapy if they fail to meet following washout criteria:\n\n  * Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies\n  * Washout\\*: \\>=2 weeks\n  * Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects\n  * Therapy: Radiation\n  * Washout\\*: \\>=3 weeks\n  * Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window\n  * Therapy: Allogeneic Stem Cell Transplant\n  * Washout\\*: \\>= 100 days since SCT; \\>= 30 days since completion of immunosuppression; \\>= 6 weeks since donor lymphocyte infusion (DLI)\n  * Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression\n  * Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy\n  * Washout\\*: \\> 30 days post infusion\n\n    * Washout: Time between therapy and apheresis\n* Positive HIV antibodies consistent with active HIV.\n* Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current\u002Factive HCV\u002FHBV.\n* Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.","3 Years","39 Years",{"count":58,"type":21},130,[60,61],"PHASE1","PHASE2","Background:\n\nAcute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses.\n\nObjective:\n\nTo test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL.\n\nEligibility:\n\nPeople aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy.\n\nDesign:\n\nParticipants will be screened. This will include:\n\nPhysical exam\n\nBlood and urine tests\n\nTests of their lung and heart function\n\nImaging scans\n\nBone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone.\n\nLumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord.\n\nParticipants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells.\n\nParticipants will receive chemotherapy starting 4 or 5 days before the CAR treatment.\n\nParticipants will be admitted to the hospital. Their own modified T cells will be returned to their body.\n\nParticipants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....",[64,65,66,67,68,69,70,71,72,73,74],"B-NHL","B-Non Hodgkin Lymphoma","Acute Lymphocytic Leukemia","Acute Lymphoblastic Leukemia","B-precursor ALL","B-All","Lymphoma, Non-Hodgkin","Leukemia, Lymphocytic, B Cell","B-Cell Lymphoma","B-Cell Leukemia","Acute Lymphoid Leukemia",[76,77,78,79,80,69,68,67,66,65],"Philadelphia chromosome + ALL","Lymphoma","CD-22 Expressing Tumor","CD-19 expressing tumor","Adoptive Immunotherapy","2026-06-30",{"date":83,"type":39},"2026-07-01",{"date":85,"type":39},"2022-12-28",{"date":87,"type":21},"2029-07-01",{"name":89,"class":90},"National Cancer Institute (NCI)","NIH",1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":111,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100600733","phase-1-a-study-of-ly4152199-in-participants-with-previously-treated-b-cell-malignancies-baffrontier-1--100600733","NCT07101328","A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )","BAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies","BAF_FRontier-1","Inclusion Criteria:\n\n* Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.\n* Participants with select tumor types must have measurable or assessable disease as defined below:\n\n  * Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.\n  * Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\\>)2 times (×) upper limit of normal (ULN) based on local laboratory testing.\n* Must be able to comply with inpatient\u002Foutpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.\n* Must have adequate organ function.\n\nPhase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed\u002Frefractory B-cell malignancy.\n\nPhase 1 Dose Optimization (Cohort B) Participants\n\n\\- Must have histologically confirmed relapsed\u002Frefractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL).\n\nExclusion Criteria:\n\nAll Participants\n\n* Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL).\n* Known or suspected central nervous system (CNS) involvement by systemic lymphoma.\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.\n* Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.\n* Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.\n* Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).\n* Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.\n* History of autoimmune disease\n* Significant cardiovascular disease\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process\n* Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).\n* Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).\n* Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody).\n* Pregnant and\u002For planning to breastfeed during the trial or within 90 days of the last dose of study intervention.\n* Known hypersensitivity to any component or excipient of LY4152199.",{"count":101,"type":21},215,[60],"The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.",[70,105,106,107,108,109,110],"B-cell Lymphoma","Lymphoma, Large B-Cell, Diffuse","Lymphoma, Follicular","Lymphoma, B-cell Marginal Zone","Waldenstrom Macroglobulinemia","Lymphoma, Mantle Cell",[112,113],"B- cell activating factor receptor (BAFFR)","Bispecific antibody","NOT_YET_RECRUITING","2026-06-19",{"date":117,"type":39},"2026-06-23",{"date":119,"type":21},"2026-06",{"date":121,"type":21},"2029-09",{"name":123,"class":46},"Eli Lilly and Company",50,{"id":126,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":25,"conditions":129,"keywords":130,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":136,"locationsCount":137},"100573185",{"count":20,"type":21},[24],[27,28],[30,31,32,33,34],"2026-06-18",{"date":133,"type":39},"2026-06-22",{"date":41,"type":39},{"date":43,"type":21},{"name":45,"class":46},152,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":91},"100532477","phase-2-a-study-of-axicabtagene-ciloleucel-and-glofitamab-as-second-line-therapy-for-relapsed-or-refractory-patients-with-large-b-cell-lymphoma-100532477","NCT06213311","A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma","A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma","Inclusion Criteria:\n\n* Histologically proven CD19- and CD20-positive LBCL, including transformation from indolent lymphomas.\n* Have disease that is refractory to or relapsed \\\u003C=12 months after the completion of first-line chemoimmunotherapy\n\n  • Refractory disease defined as no complete response (CR) to first-line therapy; participants who are intolerant to first-line therapy are excluded\n* Progressive disease (PD) as best response to first-line therapy\n* Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)\n* Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease or disease progression ≤ 12 months from completion of therapy\n\n  • Relapsed disease defined as CR to first-line therapy followed by biopsy- proven disease relapse ≤ 12 months of completing first-line therapy.\n* Participants must have received first-line therapy including:\n\n  * Anti-CD20 monoclonal antibody\n  * An anthracycline containing chemotherapy regimen\n* Age 18 or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n* Participants must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab.\n* Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:\n\n  * Absolute neutrophil count ≥ 1000\u002FμL\n  * Platelet count either ≥ 75,000\u002FμL or \\>50K if documented lymphomatous involvement of bone marrow\n  * Absolute lymphocyte count ≥ 100\u002FμL\n  * Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 ml\u002Fmin\n  * Serum alanine aminotransferase and aspartate aminotransferase ≤ 2.5 upper limit of normal (ULN)\n  * Total bilirubin ≤ 1.5 mg\u002FdL, except in participants with Gilbert's syndrome\n  * Cardiac ejection fraction ≥ 45%, no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings\n  * No clinically significant pleural effusion\n  * Baseline oxygen saturation \\> 92% on room air\n* At least 2 weeks must have elapsed since any prior systemic therapy at the time the participants is planned for leukapheresis.\n* Toxicities due to prior therapy must be recovered to Grade 1 or less (except for clinically non-significant toxicities such as alopecia).\n* No suspicion of central nervous system (CNS) involvement of lymphoma.\n* Participants must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab and with axi-cel.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with treated secondary CNS lymphoma are eligible if follow-up brain imaging after CNS directed therapy shows no evidence of disease.\n* Participants with malignancy ≤2 years, whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Participants should be without any active cardiac symptoms and an ejection fraction \\>45%, and a clinical risk assessment of cardiac function be class 2B or better using the New York Heart Association Functional Classification.\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).\n* Participants must agree to either remain completely abstinent or to use two effective contraceptive methods that result in a failure rate of \\\u003C 1% per year from screening until at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab (whichever is longer) if the participants is a male. If the participant is a female, effective contraception should be used until at least 18 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab (whichever is longer).\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of cycle-6 (C6) of glofitamab administration, and must refrain from donating sperm during this same period.\n\n  • Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Autoimmune disease:\n\n  * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.\n  * Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study.\n  * Participants with a history of Type I Diabetes Mellitus who are well controlled (defined as a screening hemoglobin A1c \\\u003C 8% and no urinary ketoacidosis) are eligible.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover \\\u003C 10% of body surface area\n* Disease is well controlled at baseline and requires only low- potency topical corticosteroids\n* No occurrence of acute exacerbations of the underlying condition requiring methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency oral corticosteroids within the previous 12 months\n* Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits, as judged by the investigator, are allowed\n\nExclusion Criteria:\n\n* Prior CAR T-cell therapy or glofitamab therapy.\n* History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring hospitalization and\u002For intravenous (IV) antimicrobials for management within 4 weeks of treatment initiation; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor.\n* History of uncontrolled human immunodeficiency virus (HIV) infection (HIV+ patients are not excluded from study if they have CD4 counts ≥ 200\u002Fµl, are on stable antiretroviral therapy for at least 1 month prior to study entry, and who have an undetectable viral load) or acute or chronic active hepatitis B or C infection; patients with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines.\n* Presence of any in dwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural\u002Fperitoneal\u002Fpericardial catheter); dedicated central venous access catheters, such as a Port-A-Cath® or Hickman® catheter, are permitted.\n* Participants with detectable cerebrospinal fluid malignant cells, brain metastases, or active CNS lymphoma.\n* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n* Participants with cardiac lymphoma involvement.\n* History of significant or extensive cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina.\n* Requirement for urgent therapy due to tumor mass effects (e.g., blood vessel compression, bowel obstruction, or transmural gastric involvement).\n* Primary immunodeficiency.\n* History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n* History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.\n* Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to axi-cel, glofitamab, obinutuzumab, or other agents used in the study.\n* Administration of a live, attenuated vaccine within 4 weeks before Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study. (Note: Influenza vaccination should be given during influenza season only). Patients must not receive live, attenuated influenza vaccine (e.g., Flumist®) at any time during the study treatment period.\n* Participants who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants who are receiving any other investigational agents.\n* Women of childbearing potential who are pregnant or breastfeeding. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.\n* Participants who are not willing to practice birth control for the duration of study participation, and 4 months after completion of C6 of glofitamab administration.\n* In the investigator's judgment, the participant is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* Participants with a known or suspected history of HLH\n* Participants with known or suspected chronic active EBV or CMV infection\n* Prior treatment with systemic immunotherapeutic agents, including but not limited to radio-immunoconjugates, antibody-drug conjugates, immune\u002Fcytokines and monoclonal antibodies (e.g., anti-CTLA4, anti-PD1 and anti-PDL1) within 4 weeks or five half-lives of the drug, whichever is shorter, before Gpt infusion.\n* Prior solid organ transplantation\n* Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)\n* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Diagnosis with SARS-CoV-2 infection within 30 days prior to the first study treatment, including asymptomatic SARS-CoV-2 infection.",{"count":146,"type":21},40,[61],"To learn if the combination of axicabtagene ciloleucel (axi-cel) and glofitamab as first-line therapy in high-risk LBCL participants or as second-line therapy in LBCL participants can help to control the disease.",[28],"2026-06-12",{"date":152,"type":39},"2026-06-15",{"date":154,"type":39},"2024-05-07",{"date":156,"type":21},"2027-07-31",{"name":158,"class":159},"M.D. Anderson Cancer Center","OTHER",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100642002","toxin-exposure-and-immune-dysregulation-in-non-hodgkin-lymphoma-100642002","NCT07652580","Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma","Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma Across the Military Healthcare System","TOXNHL","Inclusion Criteria:\n\n* Age 4 years old and older with a clinical diagnosis of B-cell NHL.\n* Must be willing to undergo phlebotomy and\u002For skin punch biopsy.\n* Must be willing to undergo whole genome sequencing, which includes return of primary and secondary findings.\n\nExclusion Criteria:\n\n* Has any condition that, in the opinion of the Principal Investigator, contraindicates participation in this study. Examples of situation that may contraindicate participation include but are not limited to a) some cases of cerebral vascular accidents where an individual no longer has the capacity to make their own medical decisions and a conservator or responsible family member is not available and b) an individual has active suicidal ideation and is a danger to themselves at the time of enrollment.\n* Does not have access to health care and primary care clinician.\n* Actively undergoing induction treatment for NHL.","4 Years",{"count":20,"type":21},"OBSERVATIONAL","The goal of this observational cohort study is to learn how toxin and occupational exposures, germline genetic variation, and immune dysregulation relate to B-cell non-Hodgkin lymphoma among active-duty service members and other Military Health System beneficiaries. The main questions are whether specific exposures and germline variants are associated with B-cell NHL subtype, immune dysfunction, and clinical outcomes. Participants will complete exposure and medical-history surveys, provide biospecimens for immune and genomic testing, and may be followed annually for up to 3 years.",[173,174,105,175],"Non-Hodgkin Lymphoma","Lymphoma Non-Hodgkin","Immune Dysregulation",[177,77,178,179],"Immunodeficiency","Exposure","Genetics","2026-06-11",{"date":182,"type":39},"2026-06-17",{"date":184,"type":39},"2025-05-01",{"date":186,"type":21},"2028-05-01",{"name":188,"class":159},"Henry M. Jackson Foundation for the Advancement of Military Medicine",3,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":91},"100446362","phase-1-phase-iii-study-of-car70--engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-relapserefractory-hematological-malignances-100446362","NCT05092451","Phase I\u002FII Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse\u002FRefractory Hematological Malignances","Inclusion criteria:\n\n1. Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry.\n2. Patients must meet diseases specific eligibility criteria (see below)\n3. Patients at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML, CML, and MDS patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until up to three days prior to administration of lymphodepleting chemotherapy.\n4. Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated to assess response\n5. Karnofsky Performance Scale \\> 50% for patients who are \\>16 years old or Lansky score ≥50% for patients who are ≤16 years of age.\n6. Adequate organ function:\n\n   1. Renal: Serum creatinine \\\u003C\u002F= 2x ULN or estimated Glomerular Filtration Rate \\>\u002F= 30 ml\u002Fmin\u002F1.73 m2\n   2. Hepatic: ALT\u002FAST \\\u003C\u002F= 3 x ULN or \\\u003C\u002F= 5 x ULN if documented liver metastases, Total bilirubin \\\u003C\u002F2xULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be \\\u003C\u002F= 3 x.ULN. No history of liver cirrhosis. No ascites.\n   3. Cardiac: Cardiac ejection fraction \\>\u002F= 40%, no clinically significant pericardial effusion as determined by an ECHO, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n   4. Pulmonary: No clinically significant pleural effusion (per PI discretion), baseline oxygen saturation \\> 92% on room air and adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) \\>50%.\n7. Able to provide written informed consent.\n8. 12-80 years of age.\n9. Weight ≥40 kg\n10. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n11. Signed consent to long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.\n12. Are willing and able to provide informed consent, as appropriate (either directly or through a legally authorized representative \\[LAR\\])\n\nExclusion criteria:\n\n1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.\n3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.\n4. HIV with detectable viral load\n5. Presence of active neurological disorder(s).\n6. Active autoimmune disease within 12 months of enrollment\n7. Amyloidosis or POEMS syndrome\n8. Active cerebral or meningeal involvement by the malignancy\n9. Active (defined as requiring therapy) acute or chronic GVHD\n10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n11. Presence of any other serious medical condition that may endanger the patient at investigator discretion.\n12. Major surgery \\\u003C4 weeks prior to first dose of the preparatory chemotherapy\n13. Allogeneic SCT or DLI \\\u003C12 weeks prior to first dose of preparatory chemotherapy\n14. Concomitant use of other investigational agents.\n15. Concomitant use of other anti-cancer agents.\n16. Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.\n17. Patients receiving immunosuppressive therapy","12 Years","80 Years",{"count":199,"type":21},80,[60,61],"The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma.\n\nImmune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.",[72,203,204,205,206,207,208,209,210,211],"Myelodysplastic Syndromes (MDS)","Acute Myeloid Leukemia (AML)","Multiple Myeloma","Plasma Cell Leukemia","Hodgkin Lymphoma","T-cell Non-Hodgkin's Lymphoma\u002F T-cell Acute Lymphoblastic Leukmeia","Myelodysplastic Syndrome \u002F Chronic Myelomonocytic Leukemia","Blastic Transformation of Chronic Myeloid Leukemia","Germ Cell Tumors","2026-06-04",{"date":214,"type":39},"2026-06-08",{"date":216,"type":39},"2022-11-01",{"date":218,"type":21},"2026-08-31",{"name":158,"class":159},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":231,"conditions":232,"keywords":247,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":230,"type":21},30,"The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[233,234,77,66,17,235,236,237,238,239,240,207,241,242,243,244,28,245,246],"Hematologic Malignancy","Leukemia","Acute Myelogenous Leukemia","AML","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","T-cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[248,249,250],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","2026-06-02",{"date":212,"type":39},{"date":254,"type":39},"2023-11-15",{"date":256,"type":21},"2027-12-01",{"name":258,"class":159},"Children's Hospital Medical Center, Cincinnati",5,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":274,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":124},"100564854","phase-1-a-study-to-investigate-safety-and-effectiveness-of-bgb-16673-in-combination-with-other-agents-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100564854","NCT06634589","A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1b\u002F2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies","Key Inclusion Criteria:\n\n* Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF\n* Confirmed diagnosis of a R\u002FR B-cell malignancy\n* Protocol-defined measurable disease\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab\n* Substudies 1, 3, and 4 Inclusion Criterion:\n\n  * Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL\u002Fmin\n* Substudy 2 Inclusion Criteria:\n\n  * Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression\n  * Adequate renal function as indicated by eGFR of ≥ 30 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Treatment-naive B-cell malignancies\n* Unable to comply with the requirements of the protocol\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively\n* Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening\n* Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period\n* Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab\n* Substudy 1 Exclusion Criterion:\n\n  * Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen)\n* Substudy 2 Exclusion Criterion:\n\n  * Participants who discontinued prior zanubrutinib treatment due to intolerance\n* Substudies 3 and 4 Exclusion Criteria:\n\n  * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment\n  * All participants with a prior allogeneic stem cell transplant\n  * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":199,"type":21},[60,61],"The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R\u002FR) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.",[271,272,273,105],"B-cell Malignancy","Relapsed Cancer","Refractory Cancer",[275,276,277,278,33,279,280,281,282,283],"R\u002FR B-Cell Malignancies","relapsed or refractory B-Cell Malignancies","B-Cell malignancy","BGB-16673","zanubrutinib","B-cell lymphoma","Bruton Tyrosine Kinase (BTK)","Mosunetuzumab","Glofitamab","2026-06-01",{"date":286,"type":39},"2026-06-03",{"date":288,"type":39},"2024-11-27",{"date":290,"type":21},"2029-12-02",{"name":45,"class":46},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":311,"leadSponsor":313,"locationsCount":91},"100640518","phase-1-phase-i-study-of-fxs0683-in-the-treatment-of-blood-tumors-100640518","NCT07616089","Phase I Study of FXS0683 in the Treatment of Blood Tumors","A Multicenter, Open, Single-arm Phase I Dose-escalation and Dose-expansion Clinical Study: Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of FXS0683 Tablets in Patients With Relapsed or Refractory Hematologic Malignancies.","FXS0683-001","Inclusion Criteria:\n\n1. Voluntary participation in the clinical trial and signing of the ICF.\n2. Age ≥ 18 years, regardless of gender.\n3. Dose escalation phase: Patients with mature B-cell malignancies diagnosed per the 2017 WHO classification who have failed standard therapies and have no appropriate treatment options. Dose expansion phase: Patients with B-cell lymphoma (2017 WHO), myeloid malignancies (2022 WHO), or acute lymphoblastic leukemia.\n4. Dose escalation phase: Evaluable disease. Dose expansion phase: For B-cell lymphoma, at least one measurable lesion per Lugano 2014 criteria.\n5. Patients must be willing to undergo bone marrow aspiration and\u002For biopsy.\n6. ECOG performance status of 0-1 (dose escalation phase) or 0-2 (dose expansion phase).\n7. Expected survival time ≥3 months.\n8. Adequate bone marrow function during screening, as defined by local laboratory reference ranges, without growth factor support.\n9. Adequate organ function, defined by laboratory values within 7 days prior to the first dose.\n10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception from signing the ICF until 6 months after the last dose.\n11. Patients at high risk of tumor lysis syndrome (TLS), defined as absolute lymphocyte count (ALC) ≥25×10⁹\u002FL with ≥1 measurable lymph node ≥5 cm or any node ≥10 cm, must be willing to comply with TLS prophylaxis and monitoring requirements.\n12. Patients must be able to comply with the study procedures and visit schedule.\n\nExclusion Criteria:\n\n1. Burkitt lymphoma\u002Fleukemia, plasma cell myeloma, or plasmablastic lymphoma.\n2. Acute promyelocytic leukemia (APL) or BCR-ABL positive AML patients, or patients with a history of myeloproliferative neoplasms (MPN).\n3. Use of cytotoxic agents, investigational drugs, or other antitumor therapies within 14 days or 5 half-lives prior to the first dose; or immunotherapy, antibody-based or peptide-based therapies, or live vaccines within 4 weeks prior to the first dose.\n4. Patients who received any therapeutic surgery other than diagnosis, biopsy, or drainage within 4 weeks before the first dose, or patients expected to undergo major surgery during the study. Patients who underwent drainage or placement of drainage tubes within 4 weeks before the first dose must have symptoms\u002Fsigns alleviated and not require prophylactic or therapeutic antibiotics.\n5. Patients who received systemic radiotherapy or palliative local radiotherapy within 4 weeks before the first dose.\n6. Toxicity from previous anticancer treatment has not recovered to ≤ grade 2, except for hair loss and pigmentation.\n7. Prior allogeneic stem cell transplantation; or autologous stem cell transplantation or CAR-T therapy within 3 months prior to the first dose.\n8. Patients with lymphoma\u002Fleukemia that has infiltrated the central nervous system.\n9. Patients with dysphagia or a history of severe gastrointestinal diseases and whose related symptoms cannot be reasonably controlled; or patients with gastrointestinal diseases affecting drug absorption or other malabsorption conditions.\n10. Active or clinically significant cardiovascular or cerebrovascular disease.\n11. Patients with interstitial lung disease or a history of pulmonary interstitial fibrosis; or evidence of active pneumonia found on screening chest CT scan.\n12. Patients with congenital immunodeficiency disorders or active autoimmune diseases, including but not limited to those with active and uncontrolled autoimmune cytopenias lasting ≥2 weeks, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.\n13. Patients with coagulation disorders.\n14. Patients with a history of severe allergies or allergies to any active or inactive component of the study drug.\n15. Patients with uncontrolled systemic infections within 2 weeks before the first dose; hepatitis B surface antigen positive with hepatitis B virus DNA \\>1000 IU\u002Fml; HCV antibody positive with HCV RNA positive; HIV antibody positive.\n16. Other primary malignancies within 5 years prior to enrollment, except for adequately treated basal or squamous cell skin cancer or carcinoma in situ.\n17. Patients who still require systemic immunosuppressive agents or systemic corticosteroids within 2 weeks before the study drug.\n18. Pregnant or breastfeeding women.\n19. Any other serious or uncontrolled acute or chronic disease or laboratory abnormality or other reasons deemed unsuitable for participation in this clinical trial by the investigator.",{"count":301,"type":21},228,[60],"This is a first-in-human, multicenter, open-label, single-arm Phase I study of FXS0683 in participants with relapsed or refractory hematologic malignancies to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity, and to determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D).",[72,305,306,67],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","2026-05-26",{"date":309,"type":39},"2026-05-29",{"date":284,"type":21},{"date":312,"type":21},"2029-08-08",{"name":314,"class":46},"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":91},"100486558","phase-2-a-phase-ii-trial-of-mosunetuzumab-polatuzumab-tafasitamab-and-lenalidomide-in-patients-with-relapsed-b-cell-nhl-100486558","NCT05615636","A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL","Inclusion criteria:\n\nPatients in safety run in must meet the following criteria for study entry:\n\n* A diagnosis of relapsed CD20+ Follicular Lymphoma grade 1-3a\n* A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma\n\nPatients in dose expansion must meet the following criteria for study entry:\n\n• A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma\n\nPatients in each component (safety run in and dose expansion) must meet the following criteria for study entry:\n\n1. Evidence of progression or lack of response following at least 1 prior treatment\n2. Able and willing to provide written informed consent and to comply with the study protocol\n3. Age ≥ 18 years as these drugs have not yet established safety and efficacy in pediatric patients\n4. At least 1 site of measurable disease greater than 1.5cm\n5. Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count ≥ 1.0 x 109\u002FL\n   * Platelet count ≥ 75 x 109\u002FL\n6. Serum bilirubin \\\u003C1.5x ULN except in patients with Gilbert fs syndrome as defined by \\> 80% unconjugated bilirubin who must have a serum bilirubin of \\\u003C4x ULN; AST (SGOT) and ALT (SGPT) ≤ 3x ULN or \\\u003C 5x ULN if hepatic metastases are present\n7. Renal function assessed by calculated creatinine clearance:\n\n   . Calculated creatinine clearance ≥30ml\u002Fmin by Cockcroft-Gault formula. See section below, \"Dosing Regimen\", regarding lenalidomide dose adjustment for calculated creatinine clearance ≥30ml\u002Fmin and \\\u003C 60ml\u002Fmin.\n8. Patients must be willing to receive transfusions of blood products.\n9. For men who are not surgically sterile, agreement to use a barrier method of contraception for ≥ 3 months after the last treatment dose. In addition, male patients must agree to request that their partners use an additional method of contraception, such as oral contraceptives, intrauterine device, barrier method of contraception, or spermicidal jelly. With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 60 days after the final dose of mosunetuzumab, 6 months after the final dose of polatuzumab vedotin, and 60 days after the final dose of tocilizumab, as applicable, to avoid exposing the embryo. Men must refrain from donating sperm during this same period.\n10. For women of reproductive potential who are not surgically sterile, agreement to use two adequate methods of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly for ≥ 12 months after the last therapeutic drug dose\n11. Females of childbearing potential (FCBP, defined as a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2)has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). must have a negative serum pregnancy test with a sensitivity of at least 50 mIU\u002FmL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women must refrain from donating eggs during this same period.\n12. All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS® program.\n13. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any study drug\n2. Prior treatment with polatuzumab vedotin\n3. Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies\n4. Prior treatment with tafasitamab and\u002For lenalidomide\n5. Autologous SCT within 100 days prior to first study treatment administration\n6. Prior treatment with CAR-T therapy within 30 days before first study treatment administration\n7. Current eligibility for autologous SCT in patients with R\u002FR DLBCL\n8. Prior allogeneic SCT\n9. Prior solid organ transplantation\n10. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n11. Regular treatment with corticosteroids during the 2 weeks prior to the start of Cycle 1, unless administered for indications other than NHL at a dose equivalent to \\\u003C 20 mg\u002Fday prednisone. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1. The use of inhaled corticosteroids is permitted The use of mineralocorticoids for management of orthostatic hypotension is permitted. Single dose of dexamethasone for nausea or B symptoms is permitted\n12. Prior systemic treatment with chemotherapy, immunotherapy, targeted and biologic therapy 4 weeks prior to C1D1.\n13. Prior treatment with radiotherapy within 2 weeks prior to C1D1. If patients have received radiotherapy within 4 weeks prior to the initiation of study treatment, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible.\n14. History of prior malignancy within the last 2 years, except for curatively treated basal or squamous cell carcinoma of the skin and low- grade in situ carcinoma of the cervix\n15. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure within past 6 months prior to screening (Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification), uncontrolled or symptomatic arrhythmias with corrected QT interval (QTc) \\> 480 msec at screening, uncontrolled diabetes mellitus, active\u002Fsymptomatic coronary artery disease, COPD, LVEF less than 40%, renal failure, uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura active infection, history of invasive fungal infection, moderate to severe hepatic disease (Child Pugh Class B or C), active hemorrhage, laboratory abnormality, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. Patients with history of cardiac arrhythmias should have cardiac evaluation and clearance.\n16. Known or suspected history of hemophagocytic lymphohistiocytosis\n17. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible after review and approval by the Medical Monitor.\n18. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 2 weeks prior to the start of cycle 1\n19. Patients with suspected active or latent tuberculosis (latent tuberculosis needs to be confirmed by positive Interferon-gamma release assay)\n20. Known or suspected chronic active Epstein-Barr virus (EBV) infection\n21. Known HIV infection. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative DNA polymerase chain reaction (PCR) and must be willing to undergo DNA PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B DNA PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative DNA PCR result to be eligible. Those who are hepatitis C DNA PCR positive will be excluded.\n22. Vaccination with live vaccines within 28 days prior to start of treatment\n23. No peripheral neuropathy ≥ grade 2 or = grade 2 with pain\n24. Pregnant or lactating females.\n25. Women of childbearing potential must have a negative serum (-human chorionic gonadotropin \\[-hCG\\]) at screening and must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.\n26. All patients with known central nervous system involvement with lymphoma.\n27. Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis not due to lymphoma.\n28. Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment).\n29. Major surgery within 4 weeks of study entry, or wound that is not healed from prior surgery or trauma.\n30. History of stroke or intracranial hemorrhage within 6 months prior to study entry.\n31. Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease).\n32. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).\n33. Prothrombin time (PT)\u002FINR or aPTT (in the absence of lupus anticoagulant) \\>2x ULN.\n34. Concurrent participation in another therapeutic clinical trial.",{"count":322,"type":21},36,[61],"To learn if giving mosunetuzumab in combination with polatuzumab vedotin, tafasitamab, and lenalidomide can help to control relapsed\u002Frefractory FL and DLBCL.",[207,72,326],"Relapsed B-cell NHL","2026-05-19",{"date":329,"type":39},"2026-05-20",{"date":331,"type":39},"2023-04-28",{"date":333,"type":21},"2027-08-19",{"name":158,"class":159},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":348,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100640264","phase-2-bendamustine-versus-fludarabinecyclophosphamide-for-lymphodepletion-in-chimeric-antigen-receptor-t-cell-immunotherapy-car-t-a-randomized-trial-100640264","NCT07593482","Bendamustine Versus Fludarabine\u002FCyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.","Bendamustine Versus Fludarabine\u002FCyclophosphamide for Lymphodepletion in CAR-T Therapy: a Randomized Trial","FC-BALANCE","Inclusion Criteria:\n\n* Diagnosis of large B-cell lymphoma (LBCL) with at least one line of previous treatment and indication for commercial CAR-T cell therapy as determined by the treating physician. This includes: Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) and all specific DLBCL subtypes, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma, and other transformed indolent B-cell lymphomas (including transformed marginal zone lymphoma and Richter's transformation). Patients with primary or secondary central nervous system (CNS) involvement are eligible.\n* Planned treatment with commercially available CAR-T cell product\n* Age ≥18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Administration of any other experimental drug within 5 half-lives or ≤ 4 weeks prior to lymphodepletion therapy starts.\n* Bendamustine 3 months before leukapheresis. After leukapheresis, bendamustine use is allowed as bridging therapy according to physician decision.\n* Previous administration of anti-CD19 CAR-T products within the last 12 months from lymphodepletion therapy start.\n* Known history of hypersensitivity to the active substance or any of the excipients found in the composition of bendamustine, fludarabine, or cyclophosphamide.",{"count":344,"type":21},92,[61],"Bendamustine and the combination of fludarabine\u002Fcyclophosphamide are fully authorized chemotherapy agents in Switzerland for lymphoma treatment and currently used in routine clinical practice as lymphodepletion strategy before CAR-T immunotherapy, as supported by retrospective studies and clinical experience across multiple centers. None of the drugs described in this protocol are being used at unapproved doses, or in an investigational formulation. Both lymphodepletion regimens have a known safety profile and the risks and burdens imposed on participants do not exceed those encountered in routine CAR-T therapy management, as all procedures (including monitoring, supportive care, and follow-up assessments) align with standard clinical practice. Based on these assumptions, this protocol is designed to investigate the use of bendamustine as an alternative lymphodepletion therapy (which is a part of CAR-T immunotherapy protocol).",[105],[349,350,351,352,353,354,355],"Large B-cell lymphoma","LBCL","B-cell malignancy","Chimeric antigen receptor (CAR) T-cell therapy","Bendamustine","Fludarabine\u002FCyclophosphamide","lymphodepletion in CAR-T therapy","2026-05-13",{"date":358,"type":39},"2026-05-18",{"date":360,"type":21},"2026-09",{"date":362,"type":21},"2030-03",{"name":364,"class":159},"Swiss Cancer Institute",9,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":91},"100640520","phase-1-efficacy-and-safety-of-cd19-carp40-t-in-patients-with-relapsedrefractory-cd19-positive-hematologic-malignancies-100640520","NCT07584889","Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed\u002FRefractory CD19-Positive Hematologic Malignancies","Efficacy and Safety of Autocrine p40-Expressing CD19-Targeted Chimeric Antigen Receptor T Cells (CD19-CAR.p40-T) in Patients With Relapsed\u002FRefractory CD19-Positive Hematologic Malignancies","CAR-p40-T","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. • Aged 18 to 75 years, male or female;\n2. • Histologically or cytologically diagnosed with relapsed\u002Frefractory CD19-positive hematologic malignancy according to the 2022 World Health Organization (WHO) diagnostic criteria;\n3. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n4. • Life expectancy of at least 3 months;\n5. • No contraindications to peripheral blood leukapheresis;\n6. • CD19 expression on tumor cells confirmed by flow cytometry and\u002For immunohistochemistry;\n7. • No severe cardiac, pulmonary, hepatic, or renal dysfunction;\n8. • Able to understand and willing to provide written informed consent. Exclusion Criteria\n\nSubjects who meet any of the following criteria should be excluded from enrollment:\n\n1. History of allergy to any component of the cellular product;\n2. Complete blood count meeting any of the following criteria: white blood cell count (WBC) ≤1 × 10⁹\u002FL, absolute neutrophil count (ANC) ≤0.5 × 10⁹\u002FL, absolute lymphocyte count (ALC) ≤0.5 × 10⁹\u002FL, or platelet count (PLT) ≤25 × 10⁹\u002FL;\n3. Laboratory abnormalities including, but not limited to, serum total bilirubin ≥1.5 mg\u002FdL; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5 times the upper limit of normal; or serum creatinine ≥2.0 mg\u002FdL;\n4. Class III or IV cardiac insufficiency according to the New York Heart Association (NYHA) functional classification, or left ventricular ejection fraction (LVEF) \\\u003C50% by echocardiography;\n5. Abnormal pulmonary function, with oxygen saturation \\\u003C92% on room air;\n6. History of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;\n7. Grade 3 hypertension with poor blood pressure control despite medication;\n8. History of traumatic brain injury, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;\n9. Autoimmune disease, immunodeficiency, or other conditions requiring treatment with immunosuppressive agents;\n10. Uncontrolled active infection;\n11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;\n12. Receipt of a live vaccine within 4 weeks prior to enrollment;\n13. Positive test results for HIV, HBV, HCV, or TPPA\u002FRPR, or HBV carrier status;\n14. History of alcohol abuse, drug abuse, or psychiatric illness;\n15. Participation in any other clinical study within 3 months prior to enrollment in this clinical study;\n16. Female subjects who meet any of the following conditions:\n\n    1. Pregnant or breastfeeding;\n    2. Planning to become pregnant during the study; or\n    3. Of childbearing potential and unwilling or unable to use effective contraception;\n17. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.","75 Years",{"count":376,"type":21},10,[60,61],"1. Study Title:\n\n   A Study on the Efficacy and safety of Autocrine p40-Expressing CD19-Targeted Chimeric Antigen Receptor T Cells (CD19-CAR.p40-T) in Patients With Relapsed\u002FRefractory CD19-Positive Hematologic Malignancies\n2. Study Objectives:\n\n   2.1.1 Primary Objective To evaluate the safety of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells (CD19-CAR.p40-T) in the treatment of patients with relapsed\u002Frefractory CD19-positive hematologic malignancies.\n\n   2.1.2 Secondary Objective To evaluate the efficacy of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells (CD19-CAR.p40-T) in the treatment of patients with relapsed\u002Frefractory CD19-positive hematologic malignancies.\n\n   2.1.3 Exploratory Objective To evaluate the in vivo expansion and persistence of CD19-CAR.p40-T cells.\n3. Participant Intervention:\n\nParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19-CAR.p40-T cell infusion. The CD19-CAR.p40-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[28,67,305],"2026-05-07",{"date":356,"type":39},{"date":383,"type":39},"2024-04-20",{"date":385,"type":21},"2029-04-19",{"name":387,"class":159},"Shenzhen University General Hospital",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":395,"maxAge":374,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":91},"100600098","phase-1-clinical-study-of-u01sscart-19-in-patients-with-b-cell-lymphoma-100600098","NCT07093073","Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma","A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.","Inclusion Criteria:\n\n1. Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.\n2. All of the following conditions must be met:\n\n   1. Age 2-75 years at informed consent; both sexes eligible. For minors (≤18 years), consent must be provided by a parent\u002Flegal guardian; minors able to sign must co-sign with their guardian.\n   2. Histologically confirmed B-cell lymphoma per the 2024 v3 NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas.\n   3. Prior therapy requirements:\n\n      * Failure to achieve PR after first-line therapy, OR relapse within 12 months after first-line therapy; or Relapsed\u002Frefractory after second-line therapy (one standard chemo-regimen + one salvage regimen).\n\n   Prior regimens must have included anti-CD20 monoclonal antibody (unless documented CD20-negative tumor) and an anthracycline-containing regimen. In addition, at least one of the following must apply:\n\n   i. Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); ii. Refusal of ASCT; iii. Relapse after ASCT. d) Disease status at screening:\n\n   • Relapse: progression after prior PR or CR.\n\n   • Refractory: i. PD during\u002Fafter last therapy, or best response ≤SD lasting \\\u003C6 months; OR ii. Relapse or progression after ASCT (biopsy-proven), including relapse\u002FPD ≤12 months post-ASCT or lack of response (SD\u002FPD) to salvage therapy after ASCT.\n3. Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.\n4. ≥1 measurable lesion per Lugano 2014 response criteria.\n5. ECOG performance status 0-3.\n6. Adequate marrow reserve: ALC ≥0.3 × 10⁹\u002FL; PLT ≥30 × 10⁹\u002FL (transfusion permitted).\n7. Adequate organ function:\n\n   • AST ≤3×ULN (≤5×ULN if tumor-related); ALT ≤3×ULN (≤5×ULN if tumor-related);• Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome);• Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault);• Pulmonary: ≤Grade 1 dyspnea and SpO₂ \\>91 % on room air;• LVEF ≥50 % by echocardiography;• INR ≤1.5×ULN and APTT ≤1.5×ULN.\n8. Women of child-bearing potential: negative serum\u002Furine pregnancy test within 7 days before CAR-T infusion. All participants with reproductive potential must use effective contraception from screening through ≥12 months after CAR-T infusion.\n9. Adequate venous access for leukapheresis or repeated phlebotomy, with no contraindications to leukapheresis.\n10. Estimated life expectancy \\>3 months.\n\nExclusion Criteria:\n\n1. Concurrent malignancy other than the study indication, except for carcinoma in situ or any malignancy with a disease-free interval ≥3 years.\n2. Presence of any of the following:• Positive HBe-Ab and\u002For HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.\n3. Active bacterial, fungal, viral, mycoplasmal, or other infection deemed uncontrollable by the investigator.\n4. History or current clinically significant CNS disorder unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-that the investigator considers uncontrolled.\n5. Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), NYHA Class III-IV congestive heart failure, myocardial infarction, unstable angina, or other clinically significant cardiac history judged by the investigator; or QTc \\>480 ms (Fridericia correction) or LVEF \\\u003C50 % by echocardiography at screening.\n6. Known primary immunodeficiency.\n7. History of severe immediate hypersensitivity to any study drug.\n8. Receipt of any live vaccine within 6 weeks before screening.\n9. Pregnant or breastfeeding women.\n10. Active autoimmune disease requiring systemic immunosuppressive therapy.\n11. Participation in any other interventional clinical trial within 30 days before signing informed consent.\n12. Any condition that, in the investigator's opinion, renders the subject unsuitable for study participation.","2 Years",{"count":230,"type":21},[60],"This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.",[28],[401,402],"CD19","ssCART-19","2026-04-29",{"date":405,"type":39},"2026-05-06",{"date":407,"type":39},"2025-01-23",{"date":409,"type":21},"2029-01-31",{"name":411,"class":46},"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":196,"maxAge":419,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":422,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":91},"100400218","phase-1-autologous-stem-cell-transplant-followed-by-polatuzumab-vedotin-in-patients-with-b-cell-non-hodgkin-and-hodgkin-lymphoma-100400218","NCT04491370","Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma","Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma","Inclusion Criteria:\n\n* Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma.\n* Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse\u002Fprogression having attained a CR, PR, or stable disease post reinduction therapy.\n* Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score.\n* Life Expectancy Patients must have a life expectancy of \\> 6 weeks.\n* Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n  1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea).\n  2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.\n* Organ Function Requirements\n\nAdequate Renal Function Defined As:\n\n* Creatinine clearance or radioisotope GFR \\> 60 mL\u002Fmin\u002F1.73 m2 or\n* A serum creatinine based on age\u002Fgender as follows:\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female\n\n* 12 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n* 16 years 1.7 1.4\n\n  * Adequate Liver Function Defined As:\n\n    * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and\n    * SGOT (AST) or SGPT (ALT) \\\u003C 3 x upper limit of normal (ULN) for age for presumed hepatic leukemia or lymphoma.\n  * Adequate Cardiac Function Defined As:\n\n    * Shortening fraction of \\> 27% by echocardiogram, or\n    * Ejection fraction of \\> 50% by radionuclide angiogram.\n  * Adequate Pulmonary Function Defined As:\n\n    • Normal respiratory rate for age and a pulse oximetry \\> 94% on room air unless due to underlying malignancy.\n  * Peripheral Blood Stem Cell Collection\n\n    • Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC collected and cryopreserved prior to start of myeloablative conditioning\n  * All patients and\u002For their parents or legal guardians must sign a written informed consent.\n\nExclusion Criteria:\n\n* Patient may not have had a prior stem cell transplant\n* Patients must not have active CNS lymphoma\n* Other concurrent investigational agents for treatment of B-cell lymphoma\n* Pregnancy and\u002For active Breast Feeding\n* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation.\n* Patient must not have an uncontrolled infection.\n* Patient must not have ≥ Grade 3 neuropathy.","70 Years",{"count":421,"type":21},20,[60,61],"Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.",[105,243,241,242,27,425,426,427,207],"Marginal Zone Lymphoma","Transformed Non-Hodgkin Lymphoma","Richter Syndrome","2026-04-10",{"date":430,"type":39},"2026-04-15",{"date":432,"type":39},"2021-08-01",{"date":434,"type":21},"2027-08-15",{"name":436,"class":159},"New York Medical College",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":4},"100632924","phase-1-study-of-nx-5948-in-combination-with-other-agents-in-adults-with-b-cell-malignancies-100632924","NCT07520006","Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies","An Open-label, Multicenter Phase 1b\u002F2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate organ and bone marrow function\n* Measurable disease by computed tomography (CT) per iwCLL\n* For R\u002FR CLL\u002FSLL, prior therapy must include treatment with a Bruton tyrosine kinase inhibitor (BTKi)\n* For 1L CLL\u002FSLL, confirmed previously untreated CLL\u002FSLL with a clinical indication for systemic treatment that meets iwCLL criteria\n* Must sign an informed consent form indicating understanding of the study purpose and procedures and willingness to participate\n\nKey Exclusion Criteria:\n\n* Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment\n* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment\n* Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation\n* Use of systemic corticosteroids (\\>20 mg\u002Fday prednisone or equivalent) within the 7 days prior to initiation of study treatment excepting those used as prophylaxis for radiodiagnostic contrast\n* Previously treated with a BTK degrader\n* Previously treated with a BCL-2 inhibitor (BCL-2i) unless eligible for retreatment\n* Known central nervous system (CNS) lymphoma or leukemia\n* Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment\n* Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment\n\nNote: Other Inclusion\u002FExclusion criteria may apply as defined in the protocol.",{"count":445,"type":21},150,[60,61],"The study will evaluate NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed\u002Frefractory (R\u002FR) or first-line (1L) chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL).",[105,449,450],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma",[452,453,454,351,455,456,248,457,458],"Chronic Lymphocytic Leukemia (CLL)","Small Lymphocytic Lymphoma (SLL)","Degrader","BTKi","Bexobrutideg","Obinutuzumab","Rituximab","2026-04-08",{"date":461,"type":39},"2026-04-13",{"date":463,"type":21},"2026-05",{"date":465,"type":21},"2033-05",{"name":467,"class":46},"Nurix Therapeutics, Inc.",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":259},"100557911","phase-1-synkir-310-for-relapsedrefractory-b-nhl-100557911","NCT06544265","SynKIR-310 for Relapsed\u002FRefractory B-NHL","A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Adult 18 years of age and older.\n* Histologically confirmed diagnosis of B-NHL before enrollment.\n* Must have received prior CAR T or were unwilling\u002Funable to receive prior CAR T.\n* Must have refractory or relapsed disease after receiving 2 prior lines of therapies.\n* If relapsed\u002Frefractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.\n* If relapsed\u002Frefractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial\n* Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Previously treated with any investigational agent within 30 days prior to screening.\n* Any previous or concurrent malignancy, with the following exceptions:\n\nAdequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \\\u003C 1.0 may also be permitted.\n\n* Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis\n* Known immunodeficiency disease , with the exception of hypoglobulinemia\n* History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia\u002Fhemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.\n* Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.\n* Any active uncontrolled systemic fungal, bacterial or viral infection.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":322,"type":21},[60],"This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed\u002Frefractory B-NHL.",[28,479,27,480,481,482,483,242,425,484,485,486,241,487,488,489,490,491,492,493,494,495,496,497,109,498],"NHL, Adult","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Aggressive B-Cell Non-Hodgkin Lymphoma","Indolent B-Cell Non-Hodgkin Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","HGBL With MYC and BCL2 and\u002For BCL6 Rearrangements","High-grade B-cell Lymphoma","Large B-cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","Non-hodgkin Lymphoma,B Cell","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Epstein-Barr Virus Positive DLBCL, Nos","Follicular Lymphoma Grade 3B","DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Lymphoma Grade 3","Marginal Zone Splenic Lymphoma","DLBCL","Waldenstrom Macroglobulinaemia",{"date":500,"type":39},"2026-04-14",{"date":502,"type":39},"2024-11-01",{"date":504,"type":21},"2028-12",{"name":506,"class":46},"Verismo Therapeutics",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":524,"leadSponsor":526,"locationsCount":4},"100632623","phase-3-study-of-nx-5948-versus-pirtobrutinib-in-rr-cllsll-100632623","NCT07516093","Study of NX-5948 Versus Pirtobrutinib in R\u002FR CLL\u002FSLL","A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed\u002FRefractory (R\u002FR) Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate organ and bone marrow function\n* Confirmed diagnosis of CLL\u002FSLL that meets iwCLL 2018 criteria for diagnosis and systemic treatment\n* Received at least one prior line of therapy for CLL\u002FSLL that included a cBTKi and must have documented disease progression during treatment with, or after discontinuation of, the cBTKi\n* Participants with SLL must have measurable disease by computed tomography (CT) per iwCLL\n\nKey Exclusion Criteria:\n\n* Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment\n* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment\n* Ongoing systemic corticosteroids ≥10 mg\u002Fday prednisone or equivalent\n* Previously treated with a BTK degrader or a noncovalent BTKi\n* Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment\n* Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment\n\nNote: Other Inclusion\u002FExclusion criteria may apply as defined in the protocol.",{"count":515,"type":21},620,[24],"The study will evaluate the efficacy and safety of NX-5948 (bexobrutideg) versus pirtobrutinib in participants with relapsed\u002Frefractory (R\u002FR) chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who are relapsed or refractory to prior covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment.",[105,449,450],[452,453,454,351,455,456,520],"Pirtobrutinib","2026-04-06",{"date":459,"type":39},{"date":119,"type":21},{"date":525,"type":21},"2032-06",{"name":467,"class":46},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":534,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":542,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":557},"100532125","phase-1-clic-2201-for-the-treatment-of-relapsedrefractory-b-cell-malignancies-100532125","NCT06208735","CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","CLIC-02: A Phase I Trial of CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","Inclusion Criteria in Cohort A:\n\nParticipants must meet the following criteria to be enrolled on the trial:\n\n1. Participants in the cohort A must be 18 years of age or older of age at time of informed consent.\n2. Participants must provide written informed consent.\n3. Participants must have a relapsed or refractory B cell lymphoma, including one of the following:\n\n   1. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),\n   2. high grade B cell lymphoma NOS,\n   3. high grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements,\n   4. primary mediastinal large B-cell lymphoma (PMBCL),\n   5. aggressive B cell lymphoma transformed from an indolent lymphoma,\n   6. mantle cell lymphoma (MCL),\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥40%,\n   2. Creatinine clearance using Cockcroft-Gault of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n6. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky Score ≥50%.\n7. Females of child-bearing potential and sexually active males must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n8. Participants with accessible disease, must be willing to undergo a tumour biopsy at enrolment. For participants with a recent (within 3 months) tumor biopsy, access to the archival biopsy is acceptable.\n\nInclusion Criteria in Cohort B:\n\n1. Participants in the cohort B must be between 1-39 years of age at the time of consent.\n2. For participants who are under the age of consent as defined by REB requirements, parent or legal guardian of the participant must provide the informed consent and the participant's assent\u002Fconsent must be obtained (if applicable).\n3. Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants in cohort B and\u002For those who have received CD22 targeted therapy must have documentation of CD22 tumour expression within the 6 months prior to study screening, and after any prior CD22 directed therapy (if applicable).\n6. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥45%,\n   2. Creatinine clearance using Cockcroft-Gault or Schwartz equation of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n7. Participants must have a Karnofsky or Lansky Score ≥50%.\n8. Participants of reproductive age must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n9. Participants must be willing to undergo a bone marrow biopsy at enrolment.\n\nExclusion Criteria:\n\n1. Any uncontrolled or serious active infection at the time of enrolment.\n2. Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.\n3. Live vaccine ≤6 weeks prior to enrolment\n4. Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.\n5. Diagnosis of primary central nervous system lymphoma (PCNSL)\n6. Treatment with any of the following in the specified time period before leukapheresis:\n\n   1. Allogeneic HCT within 3 months,\n   2. Autologous HCT within 3 months,\n   3. CD19 CAR-T cell infusion within 3 months,\n   4. Donor lymphocyte infusion (DLI) within 3 months,\n   5. Bendamustine within the last 6 months,\n   6. Any investigational agent within 30 days or 5 half-lives (whichever is shorter),\n   7. Systemic administration of therapeutic dose corticosteroids (\\>20 mg\u002Fday prednisone or equivalent for adults and ≥ 12 mg\u002Fm2\u002Fday for paediatric participants) within 7 days prior to leukapheresis.\n   8. Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks, unless used as treatment for the B cell malignancy.\n   9. Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.\n7. Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.\n8. Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.\n9. Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.\n10. Any Human Immunodeficiency Virus (HIV) infection at time of screening.\n11. Hypersensitivity to fludarabine or cyclophosphamide.\n12. Any allergy to gentamycin or its derivatives\n13. Participants who do not meet the minimum weight requirement for the planned dose level.\n14. Pregnant or nursing participants.","1 Year",{"count":536,"type":21},24,[60],"This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed\u002Frefractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion.\n\nThe primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies.\n\nThe secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201.\n\nExploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.",[73,540,541,241,486,490,27,105],"Non-Hodgkin's Lymphoma","B-cell Acute Lymphoblastic Leukemia",[543,544,545,546,547],"Chimeric Antigen Receptor T cells","CLIC-2201","CD22","Immunotherapy","CAR-T cell","2026-03-30",{"date":550,"type":39},"2026-04-03",{"date":552,"type":39},"2025-01-02",{"date":554,"type":21},"2027-08-01",{"name":556,"class":159},"British Columbia Cancer Agency",7,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":91},"100621351","phase-1-safety-and-efficacy-study-of-baff-r-car-t-cells-in-adult-subjects-with-cd19-negative-relapsed-or-refractory-b-cell-lymphoma-100621351","NCT07369492","Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma","A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily participate in clinical research and sign informed consent.\n* 2\\. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).\n* 3\\. Expected survival ≥ 3 months.\n* 4\\. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.\n* 5\\. ECOG score ≤ 2.\n* 6\\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:\n* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m²\n* Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg\u002FdL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.\n* Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \\>95% on room air.\n* 7\\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).\n* 8\\. Adequate bone-marrow reserve without blood transfusion as defined by:\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9\u002FL.\n* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\\^9\u002FL.\n* Platelets ≥ 50 x 10\\^9\u002FL.\n* Hemoglobin \\>80g\u002FL.\n* 9\\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.\n\nExclusion Criteria:\n\n* 1\\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.\n* 2\\. Infectious disease(HIV, Active Tuberculosis ect.).\n* 3\\. Active infection: hepatitis B, hepatitis C.\n* 4\\. Abnormal vital signs or refuse to receive examination.\n* 5\\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.\n* 6\\. History of severe hypersensitivity or known hypersensitivity to IL-2.\n* 7\\. Systemic or local severe infection requiring antimicrobial therapy.\n* 8\\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.",{"count":230,"type":21},[60],"The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.",[105],"2026-02-25",{"date":571,"type":39},"2026-02-27",{"date":573,"type":39},"2026-01-01",{"date":575,"type":21},"2029-01",{"name":577,"class":46},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":599},"100553348","phase-2-a-phase-ii-study-of-the-combination-of-pembrolizumab-and-atra-combination-treatment-of-relapsed-hl-and-b-nhl-100553348","NCT06484920","A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL","A Phase II Study of the Combination of Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Relapsed Hodgkin Lymphoma (HL) and B-Non-Hodgkin- Lymphoma (B-NHL)","Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Willingness to comply with all study procedures and be available for the duration of the trial\n4. Have a performance status of 0 to 2 on the ECOG Performance Scale.\n5. Life expectancy ≥12 weeks as per investigator discretion\n6. Patients with histologically proven, relapsed or refractory HL or B-NHL as follows:\n\n   1. HL after failure of at least 1 prior line of systemic therapy\n   2. Primary mediastinal large B-cell lymphoma (PMBCL) that is refractory to first-line therapy\n   3. Other B-cell NHLs after failure of at least 2 prior lines of systemic therapy. The eligible types of B-cell NHLs are:\n\n   i. Diffuse large B cell lymphoma ii. Follicular lymphoma iii. Marginal Zone lymphoma iv. Mantle Cell Lymphoma d. Indolent lymphoma are only eligible if they require systemic treatment e. Lymphocyte predominant HL are eligible Note: Formalin-fixed, paraffin embedded archival tumor sample from the primary cancer must be available for testing. If not available or sufficient, patients will be asked to undergo an US or CT guided biopsy prior to study entry to satisfy this eligibility criterion.\n7. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 10 days prior to the first study treatment: Hematological Absolute neutrophil count (ANC) ≥1,500 \u002FmcL Platelets ≥100,000 \u002F mcL Hemoglobin ≥9 g\u002FdL or ≥5.6 mmol\u002FL without transfusion or EPO dependency (within 7 days of assessment) INR and aPTT ≤1.5 x ULN; this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. Renal calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) calculated creatinine clearance ≥ 60 mL\u002Fmin Hepatic Serum total bilirubin\n\n   * 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN (patients with known Gilbert disease who have bilirubin levels ≤ 3 x ULN may be enrolled). Patients must be able to undergo biliary stenting if required before or, if required, during the trial AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR\n   * 5 X ULN for subjects with liver metastases Albumin \\>2.5 mg\u002FdL\n8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: Female of childbearing potential definition: (ECOG definition) Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n   1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n   2. Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n9. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.\n\n   Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\n   Refer to section 8.4.1 for more information.\n10. Male subjects of childbearing potential must agree to use an adequate method of contraception of the protocol, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Refer to section 8.4.1 for more information.\n11. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant, and double barrier (condom with a contraceptive sponge or contraceptive pessary). Micro-dosed progesterone preparations (\"mini-pill\") are an inadequate method of contraception during treatment with ATRA. If patients are taking this pill they should be instructed to stop, and another form of contraceptive should be prescribed instead.\n12. Patients with a history of CAR-T cell therapy are eligible if ≥ 3 months post treatment.\n\nExclusion Criteria:\n\n1. Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n2. Known brain metastases and\u002For leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n3. Significant reduction in ECOG performance status between the screening\u002F baseline visit and within 72 hours prior to commencement of treatment as per trial protocol, as per the Investigator's assessment, defined as a reduction in ECOG score to 3 or 4.\n4. Patients with a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) within 7 days prior to the first dose of trial treatment.\n\n   Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n5. Hypersensitivity to pembrolizumab or any of its excipients.\n6. Contraindication to the use of ATRA including but not limited to: patients with a history of hypersensitivity reaction to tretinoin, vesanoid or related compounds ( i.e. acitretin, isotretinoin, vitamin A); , Tetracyclines, Progesterone (low dose), drugs inducing P450 (rifampicin, glucocorticoids, phenobarbital, etc), ketoconazole and drugs inhibiting p450 (cimetidine, erythromycin, cyclosporine, etc); antifibrinolytic agents (e.g. tranexamic acid, aminocaproic acid, aprotinin) and hydroxyurea)\n7. Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day -1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n8. Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day -1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Subjects with chronic conditions such as vision changes or prior hearing loss that is not reasonably expected to be exacerbated by the investigational product may be included. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: Subjects with Grade 2 adrenal insufficiency or thyroid conditions who are not expected to resolve to baseline, are on a stable dose of medication may be included if it is not reasonably expected to be exacerbated by the investigational product, and asymptomatic whilst on treatment.\n9. History of malignancy in the last 5 years with the exception of prior history of in situ cancer or basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.\n10. Patient has undergone major surgery, other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day -1 of treatment in this study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n11. Known history of, or any evidence of active, non-infectious pneumonitis.\n12. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.\n13. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n14. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n15. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.\n16. Patients on micro-dosed progesterone preparations (\"mini-pill\") who are unwilling to receive an alternative form of contraception.\n17. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n18. Known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies)\n19. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n20. known history of active TB (Bacillus Tuberculosis).\n21. Receipt of live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n22. Patients who receive a COVID shot and\u002For booster within 4 weeks of Cycle 1 Day -1.\n23. Known sensitivity to retinoic acid derivatives.\n24. Patient is taking any prohibited concurrent medication, including Vitamin A supplements, and CYP3A modulators (inducers and inhibitors) and is unwilling to stop use (washout period of 3 days for this protocol) prior to treatment start and during the trial.\n25. History of allogenic stem cell transplant or received a solid organ transplant. Note: If history of transplant is ≥ 5 years, subjects may be deemed eligible at the discretion of the treating physician. Note: Patients with a history of autologous stem cell transplant performed for lymphoma are eligible.",{"count":536,"type":21},[61],"This is a Phase II single-center open label trial of the combination of ATRA and pembrolizumab treatment in patients with histologically proven, relapsed or refractory Hodgkin Lymphoma or B-Non-Hodgkin-lymphoma.",[589,590,480,481,105],"Relapsed Hodgkin Lymphoma","Refractory Hodgkin Lymphoma","2026-02-07",{"date":593,"type":39},"2026-02-10",{"date":595,"type":39},"2024-11-18",{"date":121,"type":21},{"name":598,"class":159},"Rita Assi",2,{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":610,"conditions":611,"keywords":612,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":91},"100543011","phase-2-rituximab-and-zanubrutinib-in-patients-with-indolent-b-cell-lymphomas-100543011","NCT06350318","Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas","A Phase 2 Open-Label, Multicenter Study of Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas","Inclusion Criteria:\n\n* Cohort A: Previously untreated MZL. Prior therapy with H. Pylori antibiotic therapy or hepatitis C antiviral therapy are allowed on Cohort A.\n* Cohort B: Previously untreated FL\n* Pathological confirmation of lymphoma: availability of archival tissue confirming diagnosis of MZL (cohort A) or FL (cohort B). Availability of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens from within past 18 months from screening and pathological diagnosis confirmed by a pathologist at the participating site or willingness of the participant to undergo a fresh tumor biopsy if adequate archival tissue not available is required. This includes:\n* MZL (Cohort A):\n\n  1. Nodal MZL requiring systemic therapy\n  2. Splenic MZL requiring systemic therapy\n  3. Extra-nodal marginal zone lymphoma:\n\n     1. Non-gastric\u002Fnon-cutaneous MZL requiring systemic therapy.\n     2. Cutaneous MZL will be eligible only if they have pathologically confirmed extra-cutaneous disease.\n     3. Gastric MZL only if advanced stage disease requiring systemic therapy (e.g., stage IIE, II2, IV- supradiaphragmatic nodal or disseminated extranodal disease such as bone marrow or additional extra nodal sites.\n* FL (Cohort B):\n\n  a. Pathological grade 1, 2, or 3a based on the World Health Organization (WHO 2008) classification of tumors of hematopoietic and lymphoid tissue.\n\n  1\\. Please note, grade 3B are excluded.\n* All participants must have disease requiring systemic therapy rather than local radiation (ie, stage II only if not eligible for radiation therapy or with stage III\u002FIV).\n* All participants should have measurable disease. Measurable disease is defined as a lymph node or tumor mass that is ≥ 1.5 cm in at least one dimension by CT or the CT portion of the PET\u002FCT.\n* Documentation of CD20+ status.\n* All participants must have an indication for therapy such as: symptoms attributable to lymphoma, threatened end-organ function, or cytopenia secondary to lymphoma.\n* All participants must be 18 years of age or older.\n* All participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n* All participants must be able to swallow whole pills.\n* All participants must have the ability and willingness to comply with the requirements of the study protocol.\n* All female participants who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).\n* All female participants of childbearing potential must have a negative serum pregnancy test upon study entry.\n* All male and female participants of reproductive potential who agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices \\[IUDs\\], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy. Female participants of reproductive potential who are not surgically sterile must practice adequate birth control for a minimum of 30 days after last dose of zanubrutinib or 12 months after last dose of rituximab, whichever is longer. Male participants are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception in combination with other methods described above during the study treatment period and for ≥ 30 days after the last dose of zanubrutinib, or 12 months after the last dose of rituximab, whichever is longer.\n* All participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Prior therapy for lymphoma including chemotherapy or immunotherapy. Participant may have received corticosteroids but should be off them 5 days prior to study entry.\n* Prior exposure to a BTK inhibitor.\n* Known prior significant hypersensitivity to rituximab (not including infusion reactions).\n* Prior history of malignancies unless the patient has been disease free for ≥ 2 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, localized prostate cancer, or superficial bladder cancer that has undergone curative therapy.\n* Participants with evidence of large B cell transformation or other aggressive histology (such as large cells seen on biopsy or high PET avidity in a single node seen on PET scan) are not eligible.\n* Known central nervous system (CNS) involvement by lymphoma.\n* Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).\n* Concomitant use of warfarin or other Vitamin K antagonists.\n* Requires ongoing treatment with a moderate or strongCYP3A inhibitor or inducer.\n* Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1.\n* Known infection with human immunodeficiency virus (HIV).\n* Viral Hepatitis:\n\n  1. Participants with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of detectable serum hepatitis B DNA viremia are not eligible for this study.\n  2. Participants with a positive hepatitis B core antibody but with negative hepatitis B DNA may be considered for participation, but must agree to receive appropriate hepatitis B antiviral therapy while on rituximab and have hepatitis B DNA monitored with real-time PCR by the treating physician. These patients should be referred to a hepatologist or gastroenterologist for appropriate monitoring and management.\n  3. Hepatitis C: Patients with positive hepatitis C serology unless HCV RNA is confirmed negative by PCR.\n* Vaccination with a live vaccine ≤ 28 days prior to the start of treatment.\n* Participants should not have a history of uncontrolled seizures.\n* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment on the study.\n* Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg at screening.\n* Participants should not have a stroke or intracranial hemorrhage within last 6 months.\n* Participants may not have had major surgery within 28 days of enrollment, or minor surgery within 7 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.\n* Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.",{"count":608,"type":21},43,[61],"The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas).",[242,425,72],[72,242,425],"2026-02-03",{"date":615,"type":39},"2026-02-05",{"date":617,"type":39},"2024-04-19",{"date":619,"type":21},"2029-03",{"name":621,"class":159},"H. Lee Moffitt Cancer Center and Research Institute",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":91},"100609168","anti-cd19-gene-therapy-for-b-cell-lymphoma-100609168","NCT07211048","Anti CD19 Gene Therapy for B-cell Lymphoma","Early Exploratory Clinical Study of CD19-targeted Gene Injection (LCAR02) in Patients With Relapsed\u002FRefractory B-cell Lymphoma","Inclusion Criteria:\n\n* (1)Age 18 years or older, any gender; (2)Patients diagnosed with any of the following conditions: diffuse large B-cell lymphoma (DLBCL), germinal center or activated B-cell type; primary cutaneous DLBCL; primary mediastinal (thymic) large B-cell lymphoma; ALK-positive anaplastic large B-cell lymphoma; high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements; high-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma; follicular lymphoma; mantle cell lymphoma; large cell transformation of CLL. Patients must have previously received at least second-line standard treatment and either did not achieve remission or relapsed after remission; (3) For B-cell lymphoma patients, according to the preliminary assessment, staging, and response evaluation recommendations for Hodgkin and non-Hodgkin lymphomas (2014 edition), there must be at least one measurable lesion at baseline, which is defined as a lymph node lesion with a long diameter \\>15 mm or an extranodal lesion with a long diameter \\>10 mm, diagnosed by PET-CT or CT imaging; (4) B-cell lymphoma patients must have tumor cells confirmed CD19 positive by immunohistochemistry; (5) Adequate vital organ function: liver function meeting: ALT ≤3×ULN, AST ≤3×ULN; serum creatinine ≤140 μmol\u002FL; total bilirubin ≤2×ULN, or ≤3×ULN in patients with Gilbert's syndrome; hemodynamically stable as determined by echocardiography or multi-gated radionuclide angiography (MUGA) with left ventricular ejection fraction (LVEF) ≥45%; no active pulmonary infection, and percutaneous arterial oxygen saturation ≥92% without supplemental oxygen; (6) ECOG performance status: 0-2; (7) Expected survival of more than 3 months; (8) Female and male participants of childbearing potential must agree to use reliable and effective contraception from the time of signing the informed consent form until 2 years after receiving LCAR02 infusion (excluding natural family planning methods).\n\nExclusion Criteria:\n\n* (1) Patients who have experienced central nervous system diseases or pathological changes within 6 months before screening, including but not limited to: stroke, cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome, or mental disorders.\n\n  (2) Patients with malignant tumors other than B-cell lymphoma. (3) Patients who received vaccines or B-cell targeted therapy within 4 weeks before screening.\n\n  (4) Patients with systemic autoimmune diseases or immunodeficiency. (5) Patients with grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening.\n\n  (6) Patients with relatively severe heart disease, such as angina, myocardial infarction, heart failure, or arrhythmia.\n\n  (7) Patients with a history of severe allergies to the drugs or excipients used in the clinical study or investigational drugs.\n\n  (8) Patients with active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis.\n\n  (9) Patients with active infections requiring intravenous antibiotics or hospitalization.\n\n  (10) Pregnant or breastfeeding women.",{"count":630,"type":21},18,[632],"NA","This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed\u002Frefractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19 gene injection",[105],[280],"2026-01-19",{"date":638,"type":39},"2026-01-21",{"date":640,"type":21},"2026-03-20",{"date":642,"type":21},"2029-12-31",{"name":644,"class":645},"Anhui Provincial Hospital","OTHER_GOV",{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":22,"phases":655,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":189},"100423334","phase-2-mosunetuzumab-with-lenalidomide-augmentation-as-first-line-therapy-for-follicular-and-marginal-zone-lymphoma-100423334","NCT04792502","Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma","BrUOG 401: A Phase 2 Study of Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.\n2. Age ≥18 years at the time of signing informed consent. Because no dosing or adverse event data are currently available on the use of mosunetuzumab in patients \\\u003C18 years of age, they are excluded from this study.\n3. Histologically confirmed diagnosis of:\n\n   * follicular lymphoma (grade 1, 2, 3a, or not otherwise specified) or\n   * marginal zone lymphoma (nodal, extranodal, or splenic), according to 2016 WHO classification and confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry. Patients in whom definitive pathologic subtype of FL\u002FMZL is undetermined due to limited biopsy material can be enrolled if in the investigator's opinion integrated clinicopathologic data are consistent with the eligible diagnosis.\n4. Agreement to provide, if available, lymphoma tissue for correlative analyses.\n5. At least one bi-dimensionally measurable nodal lesion, defined as \\>1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \\>1.0 cm in its longest diameter; with the exception of splenic MZL, which must be evaluable using the International SMZL Group criteria.\n6. No prior systemic therapy for B-cell lymphoma, except for palliative corticosteroids; prior local therapy (surgery, radiation therapy, or antibiotics) is allowed.\n7. Indication to start systemic therapy for lymphoma:\n\n   * Patients with FL must meet one of the GELF criteria:\n\n     * any mass ≥7 cm (except spleen);\n     * at least 3 nodes \\>3 cm in diameter;\n     * symptomatic spleen enlargement;\n     * local symptoms or compromise of normal organ function due to tumor mass;\n     * presence of ascites or pleural effusion;\n     * presence of B symptoms (fever, night sweats, or unintentional weight loss of \\>10% over ≤6 months);\n     * serum lactate dehydrogenase or beta-2-microglobulin above upper limit of normal;\n     * cytopenias due to underlying lymphoma (i.e., absolute neutrophil count \\\u003C1.0 × 109\u002FL, hemoglobin \\\u003C10 g\u002FdL, and\u002For platelet count \\\u003C100 × 109\u002FL).\n   * Patients with MZL must have an indication to start therapy as assessed by the investigator.\n8. Performance status ECOG 0, 1, or 2.\n9. Adequate hematologic function (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly):\n\n   * hemoglobin ≥9 g\u002FdL,\n   * absolute neutrophil count ≥1.0 x 109\u002FL,\n   * platelet count ≥75 x 109\u002FL.\n10. Glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73m2 using the Mayo Quadratic Formula.\n11. The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because lenalidomide used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) and refrain from donating eggs or sperm throughout the treatment and for 3 months after the last dose of trial therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n12. Agreement to enroll in and comply with all local requirements of the REVLIMID® (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS®) program for the purpose of lenalidomide acquisition.\n\nExclusion Criteria:\n\n1. Grade 3b follicular lymphoma or transformed lymphoma.\n2. Prior treatment with any anti-CD20 antibody or lenalidomide for lymphoma.\n3. Prior stem cell transplantation (autologous or allogeneic) or prior solid organ transplantation.\n4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.\n5. Known NYHA class 3\u002F4 congestive heart failure, LVEF \\\u003C40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia.\n6. Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen.\n7. History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the exception of: hypothyroidism (on stable dose of thyroid replacement therapy), asthma managed with inhaled medications only; type 1 diabetes mellitus on stable insulin regimen, Sjögren syndrome, immune thrombocytopenia or autoimmune hemolytic anemia that does not require systemic therapy; dermatologic condition (including eczema, psoriasis, lichen simplex chronicus, or vitiligo) with skin manifestations with rash covering \\\u003C10% of body surface area and not requiring treatment other than low-potency topical corticosteroids for \\>12 months prior to registration.\n8. Use of any systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment using \\\u003C10 mg\u002Fday prednisone or equivalent within 2 weeks prior to first treatment; a brief course of palliative corticosteroids at higher doses (prednisone up to 100 mg daily, for up to 7 days) is allowed, but must be completed at least 7 days before the first dose of mosunetuzumab.\n9. Any of the following conditions:\n\n   * active bacterial infection requiring antibiotics\n   * known or suspected chronic active Epstein Barr virus (CAEBV) infection\n   * history of hemophagocytic lymphohistiocytosis (HLH)\n   * confirmed progressive multifocal leukoencephalopathy (PML)\n   * known active EBV or CMV viremia\n   * positive test for hepatitis B surface antigen (HBSAg). Patients with a positive total\u002FIgG hepatitis B core antibody (HBcAb) may participate if hepatitis B virus (HBV) DNA is undetectable at screening, if they agree to take entecavir or tenofovir, and undergo periodic DNA testing\n   * positive hepatitis C virus (HCV) antibody, unless a negative polymerase chain reaction (PCR) for HCV is documented\n   * positive test for HIV.\n10. Administration of a live, attenuated vaccine within 4 weeks before first mosunetuzumab dose or anticipation that such a live, attenuated vaccine will be required during the study.\n11. Current or past history of CNS disease, including stroke, epilepsy, or CNS vasculitis, or an advanced neurodegenerative disease; with the exception of: stroke \\>2 years before registration without any residual neurologic deficits and no subsequent transient ischemic attacks; history of epilepsy with no seizures for \\>2 years and not using any antiepileptic therapy; well-controlled Parkinson's disease (with no need for a significant medication adjustment for \\> 6 months).\n12. History of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a curatively treated skin cancer, in situ cervical cancer, or another malignancy treated curatively with a documented remission \\>2 years before registration are eligible.\n13. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the first dose of mosunetuzumab.\n14. Clinically significant liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.\n15. Any major surgery within 4 weeks before the first dose of mosunetuzumab, other than lymph node biopsy for diagnosis.\n16. Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol.\n17. Any of the following abnormal laboratory values within 14 days prior to first dose of mosunetuzumab:\n\n    * AST or ALT \\>3x ULN\n    * total bilirubin \\>2 x ULN (unless due to Gilbert syndrome with indirect hyperbilirubinemia only)\n    * INR\\>1.5 x ULN without anticoagulation\n    * PTT or APTT \\>1.5x ULN in the absence of lupus anticoagulant.\n18. Any radiation therapy within 2 weeks prior to first dose of mosunetuzumab.\n19. Pregnancy, breast-feeding, or prisoner status. Women of childbearing potential must have a negative pregnancy test within 2 weeks before first dose of mosunetuzumab, and must undergo repeat pregnancy testing during each cycle of lenalidomide therapy (see Inclusion Criterion 11).",{"count":654,"type":21},52,[61],"BrUOG-401 is a prospective, single-arm, phase 2 trial of first-line therapy in adult patients with previously untreated FL or MZL. All patients will be assigned the same initial treatment plan, modified by interim response assessment (IRA) after Cycle 4. All patients will start treatment with four 21-day cycles (C1-4) of mosunetuzumab alone (using step-up dosing during C1), followed by IRA. Patients who achieve CR at IRA will continue with additional 4 cycles (C5-8) of mosunetuzumab. Patients who achieve PR at IRA will receive mosunetuzumab with lenalidomide augmentation during C5-8. Primary response assessment (PRA) will occur after C8. Patients who remain in PR at PRA will continue for additional 4 cycles (extended augmentation).",[242,425,105],"2025-12-27",{"date":660,"type":39},"2025-12-30",{"date":662,"type":39},"2022-07-14",{"date":664,"type":21},"2027-08-31",{"name":666,"class":159},"Brown University",{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":22,"phases":677,"briefSummary":678,"conditions":679,"keywords":684,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":698,"lastUpdatePostDateStruct":699,"startDateStruct":701,"completionDateStruct":702,"leadSponsor":704,"locationsCount":91},"100605748","phase-1-bispecific-car-t-cells-for-b-cell-malignancies-basecar-01-trial-100605748","NCT07166549","Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)","A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies","BaseCAR-01","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including:\n\n  * Acute B-lymphoblastic leukaemia\n  * Burkitt lymphoma\n  * Primary CNS lymphoma\n  * DLBCL or high-grade lymphoma of any subtype\n  * Primary mediastinal B cell lymphoma (including grey zone lymphoma)\n  * Mantle Cell lymphoma\n  * Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)\u002F small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma\u002Fleukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma\n* CD19 and\u002For CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry)\n* ECOG clinical performance status ≤2\n* Able to provide written informed consent.\n* Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as:\n\n  * Adequate hepatic function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 × (ULN) and serum bilirubin ≤2.0 × ULN (except in congenital hyperbilirubinemia, such as Gilbert syndrome, where direct bilirubin ≤3.0 × ULN is allowed)\n  * Adequate renal function: creatinine clearance ≥30 mL\u002Fmin\u002F1.73 m2\n  * Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation \\> 91% with room air.\n  * Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia\n  * Adequate bone marrow reserve (Hemoglobin ≥80 g\u002FL (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10\\^9\u002FL (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10\\^9\u002FL (prior growth factor support is permitted but must be without support in the 7 days before the laboratory test), Absolute Lymphocyte Count ≥0.3 ×10\\^9\u002FL)\n* Willingness to practice highly effective methods of birth control, and, in females of childbearing potential, negative urine or serum pregnancy test before study inclusion, lymphapheresis, and lymphodepleting chemotherapy.\n\nExclusion Criteria:\n\n* Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs\n* Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease.\n* Uncontrolled coronary artery disease or uncontrolled arrhythmias\n* Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status.\n* Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma).\n* Active secondary malignancy that progressed or required treatment in the last 24 months, other than basal or squamous cell carcinomas of the skin. Further allowed exceptions are: Non-muscle-invasive bladder cancer, non-invasive cervical cancer, or other malignancy that is considered cured or to have a minimal risk of recurrence (e.g. a history of localized prostate or localized and treated breast cancer).\n* Uncontrolled active bacterial, fungal, or viral infections, particularly active hepatitis B, hepatitis C, or HIV infection.\n* Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including previous severe reactions to dimethyl-sulfoxide\n* Cytotoxic chemotherapy within 14 days before apheresis collection for CAR-T cells, respectively 12 weeks for Bendamustin and Fludarabine, and 6 months for Alemtuzumab and ATG.\n* Cytotoxic chemotherapy (except for lymphodepletion) within 14 days of CAR-T cell infusion.\n* Patients who have undergone allogeneic hematopoietic stem cell transplantation less than 12 weeks ago, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n* Previous CAR-T cell therapy within 12 weeks of planned CAR-T cell infusion.\n* Investigational treatments within other trials ≤ 4 weeks before enrollment.\n* Lack of safe contraception; Women who are pregnant or breastfeeding; and men who plan to father a child while enrolled in this study within 1 year of receiving bispecific anti-CD20, anti-CD19 CAR T cells.",{"count":676,"type":21},12,[60],"This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma\u002Fleukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options.",[680,681,28,682,683],"B Cell Malignancies","B-cell Leukemia","Bispecific Chimeric Antigen Receptor (CAR) T Cells","Relapsed or Refractory (r\u002Fr) B-cell Malignancies",[685,686,687,688,689,690,691,692,693,694,695,696,697],"Bispecific anti-CD19, anti-CD20 CAR T cell therapy","lymphapheresis","lymphodepleting (non- myeloablative) chemotherapy","Immune effector cell-associated neurotoxicity syndrome (ICANS)","Cytokine release syndrome (CRS)","Immune effector cell-associated haematotoxicity (ICAHT)","European Group for Blood and Marrow Transplantation (EBMT)","18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)","positron emission computed tomography (PET CT)","acute lymphocytic leukemia (ALL)","immunoglobulin heavy chain (IGH)","non-Hodgkin's lymphoma (NHL)","Eastern Cooperative Oncology Group (ECOG)","2025-12-17",{"date":700,"type":39},"2025-12-24",{"date":119,"type":21},{"date":703,"type":21},"2028-11",{"name":705,"class":159},"University Hospital, Basel, Switzerland"]