[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-large-b-cell-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644618","early-phase-1-gofast-car-t-cell-therapy-for-recurrent-refractory-b-cell-lymphoma-100644618",false,"NCT07670260","GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma","Exploratory Clinical Study of GoFast CAR T-Cell Platform Targeting CD19 CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically or cytologically confirmed primary refractory or relapsed\u002Fprogressive large B-cell lymphoma.\n* Expected survival of more than 3 months.\n* CD19-positive B-cell lymphoma confirmed by flow cytometry or immunohistochemistry.\n* ECOG performance status of 0 to 2 or KPS score greater than 80.\n* Adequate venous access for leukapheresis or peripheral blood collection, with no contraindication to blood cell separation.\n* White blood cell count ≥ 1 × 10\\^9\u002FL and lymphocyte count ≥ 0.3 × 10\\^9\u002FL.\n* INR \\\u003C 1.7 or prothrombin time prolonged by less than 4 seconds above the normal value.\n* ALT and AST ≤ 2.5 × upper limit of normal.\n* Total bilirubin ≤ 2.0 mg\u002FdL, equivalent to 34.2 μmol\u002FL.\n* Able to understand and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Active hepatitis B virus or hepatitis C virus infection.\n* HIV\u002FAIDS infection.\n* Any uncontrolled active infection.\n* Systemic corticosteroid use within 2 weeks before signing informed consent, except inhaled corticosteroids.\n* Active cardiac disease requiring treatment or poorly controlled hypertension.\n* Unstable or active ulcer disease or gastrointestinal bleeding.\n* History of organ transplantation or currently awaiting organ transplantation.\n* Central nervous system involvement by lymphoma.\n* Current participation in another clinical trial.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical study.","ALL","18 Years",{"count":19,"type":20},9,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is an investigator-initiated, prospective, open-label exploratory clinical study designed to evaluate the safety and preliminary efficacy of GoFast CD19 CAR T-cell therapy in adult patients with recurrent or refractory B-cell lymphoma. Eligible patients will undergo screening, baseline assessment, peripheral blood or leukapheresis collection, lymphodepleting chemotherapy, and intravenous infusion of GoFast CD19 CAR T cells. The study plans to enroll 9 participants using a sequential dose-escalation design. The primary outcome is objective response rate, and secondary outcomes include complete remission rate, overall survival, progression-related survival outcomes, duration of response, MRD negativity, and adverse events.",[26],"Relapsed or Refractory Large B-cell Lymphoma",[28,29,30,31,32,33,34],"CD19","CAR T-Cell Therapy","GoFast Platform","Large B-Cell Lymphoma","Relapsed or Refractory Lymphoma","Dose Escalation","Autologous CAR T Cells","NOT_YET_RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":20},"2026-06-30",{"date":43,"type":20},"2028-06-30",{"name":45,"class":46},"Chinese PLA General Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100629832","phase-3-study-evaluating-the-efficacy-of-kite-753-versus-axicabtagene-ciloleucel-in-participants-with-relapsed-or-refractory-large-b-cell-lymphoma-after-first-line-therapy-100629832","NCT07479797","Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy","A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy","Key Inclusion Criteria:\n\n* Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below:\n\n  * World Health Organization (WHO):\n\n    * Individuals with chemorefractory disease to first-line therapy (primary refractory disease) that satisfies any of the following criteria:\n\n      * Progressive disease (PD) and\u002For Deauville score of 5 (irrespective of the response designation) as the best response during the first-line treatment or as the end of treatment response following first-line therapy.\n      * Stable disease (SD) after at least 4 cycles of first-line therapy (eg, 4 cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)).\n      * PR as best response after at least 6 cycles of first-line therapy (eg, 6 cycles of R-CHOP).\n      * Note: A biopsy is recommended to confirm residual disease.\n    * Individuals with relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapsed ≤ 12 months of completion of first-line therapy.\n    * Note: If the relapse is confirmed by imaging per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma within 12 months, the confirmatory biopsy must be performed within 90 days of the 12-month cutoff.\n    * Prior therapy must have included an anti-CD20 antibody (including CD20-targeting T-cell engager antibodies) and an anthracycline-containing chemotherapy regimen.\n    * For individuals with transformed indolent NHL, therapies given for non-transformed disease do not count as a line of therapy for the transformed disease.\n    * Individuals who have had no additional systemic therapy or holding therapy (except for steroids and\u002For local radiation) following first-line therapy and prior to leukapheresis are eligible.\n* At least 1 measurable lesion according to the IWG Lugano Response Criteria. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. A measurable lesion is defined as \\>1.5 cm longest transverse diameter (LDi) for lymph node and \\> 1.0 cm LDi for extranodal lesion. Splenomegaly or hepatomegaly alone in the absence of a measurable lesion is not considered to be measurable disease.\n* The following washout period must be satisfied:\n\n  * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the individual is randomized.\n* Toxicities due to immediate prior therapy must have recovered to Grade 1 or lower (except for clinically nonsignificant toxicities such as alopecia, unless otherwise specified in the protocol)\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Adequate bone marrow function as evidenced by:\n\n  * Absolute neutrophil count ≥ 1,000\u002FμL or ≥ 500\u002FμL if documented bone marrow involvement of lymphoma. Bone marrow involvement by lymphoma is demonstrated by positron emission tomography (PET) scan or bone marrow aspiration or bone marrow biopsy.\n  * Platelet count ≥ 75,000\u002FμL (unless secondary to bone marrow or spleen involvement by lymphoma, in which platelet count ≥ 50,000 μL is permitted). Bone marrow involvement by lymphoma is demonstrated by PET scan or bone marrow aspiration or bone marrow biopsy. Spleen involvement by lymphoma is demonstrated by PET-diagnostic computed tomography (CT) involvement, splenomegaly, or biopsy.\n* Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\n\n  * Creatine clearance (as estimated by Cockcroft-Gault formula) ≥ 30 mL\u002Fminute. Note: 24-hour urine estimate is also acceptable.\n  * Serum alanine aminotransferase\u002Faspartate aminotransferase ≤ 3.0 times the upper limits of normal, except in individuals with documented liver involvement by lymphoma via PET-diagnostic CT scan or biopsy\n  * Total bilirubin ≤ 1.5 mg\u002FdL, except in individuals with Gilbert's Syndrome or documented liver or pancreatic involvement where ≤ 3.0 times the upper limit of normal is permitted\n  * Cardiac ejection fraction ≥ 40% and no pericardial effusion Grade 3 or higher (per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0) as determined by an echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) (if ECHO not available at the site). Note: If there is any concern for pericardial effusion, an ECHO must be performed since MUGA alone is not an adequate modality to assess for pericardial effusion.\n  * No evidence of Grade 2 (per CTCAE v5.0) or greater pleural effusion or ascites (individuals with Grade 1 ascites or pleural effusion are eligible)\n  * Baseline oxygen saturation \\> 92% on room air\n* Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test (females who have undergone surgical sterilization or have been postmenopausal for at least 2 years before randomization are not considered to be of childbearing potential.\n\nKey Exclusion Criteria:\n\n* Prior CAR T-cell therapy or other cell-based therapy.\n* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease-free and without anti-cancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. Individuals with asymptomatic localized low-grade prostate cancer for which a watch-and-wait approach is standard of care are eligible.\n* Individuals with the following LBCL fifth edition of WHO criteria subtypes: Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, T-cell\u002Fhistiocyte-rich LBCL, mediastinal gray zone lymphoma, plasmablastic lymphoma, intravascular LBCL, primary central nervous system (CNS) lymphoma, primary vitreoretinal LBCL, fibrin-associated LBCL, fluid overload-associated LBCL lymphomatoid granulomatosis, high-grade B-cell lymphoma (HGBCL) with 11q aberrations, anaplastic lymphoma kinase-positive LBCL, LBCL with Interferon Regulatory Factor 4 (IRF4) rearrangement, and transformed from Hodgkin's lymphoma (HL). Note: Individuals with primary testicular LBCL are eligible.\n* History of a severe, immediate hypersensitivity reaction attributed to aminoglycosides\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management. Note: Simple urinary tract infections and uncomplicated bacterial or viral upper respiratory tract infections are permitted if the individual is responding to active treatment and satisfies the criteria of being afebrile for 48 hours (ie, temperature \\\u003C 38°C).\n* Known history of hepatitis B virus (HBV) (hepatitis B surface (HBs) antigen (HBsAg) positive) infection, or hepatitis C (anti-hepatitis C virus (HCV)) positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing. Note: Individuals who are seropositive for HBV (ie, HBs and\u002For hepatitis B core antibody positive) are eligible if they are HBsAg-negative and negative for viral DNA. Individuals who are seropositive because of HBV vaccination are eligible (ie, HBs antibody positive, hepatitis core antibody-negative, and HBsAg-negative). Individuals on prophylactic and suppressive antiviral medications against HBV and\u002For HCV administered per institutional or clinical practice guidelines are eligible.\n* HIV-positive, unless taking appropriate anti-HIV medications, with an undetectable viral load by qPCR and a CD4 count ≥ 200 cells\u002FμL. Note: HIV-positive individuals in Australia are not permitted regardless of active antiretroviral therapy or undetectable blood viral load.\n* History or presence of the following CNS disorders: hemorrhage, dementia (per CTCAE v5.0 Grade 2 or higher memory impairment), cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema with confirmed structural defects by appropriate imaging.\n* History of stroke or transient ischemic attack within 6 months before enrollment. Individuals with seizure disorders requiring active anticonvulsive medication.\n* Individuals with cardiac atrial or cardiac ventricular lymphoma involvement.\n* Individuals with secondary CNS lymphoma.\n* Individuals with full thickness lymphoma involvement of gastric or intestinal lining. Individuals with concern for gastric or intestinal perforation or known contained perforation.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active unstable\u002Funcontrolled arrhythmia, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within the 6 months before enrollment.\n* Requirement for urgent therapy within 4 weeks before enrollment due to ongoing or impending oncologic emergency (eg, tumor mass effect)\n* Presence of primary immunodeficiency.\n* History of any medical condition including but not limited to autoimmune disease (eg, Crohn's, rheumatoid arthritis, or systemic lupus) resulting in end organ injury or requiring systemic immunosuppression and\u002For systemic disease-modifying agents within the last 90 days. Note: At least 90 days or 5 half-lives, whichever is shorter, must have elapsed after any prior immunosuppressive or immunomodulating therapy that impacts T-cell function and before leukapheresis.\n* History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome.\n* Any medical condition or residual toxicities from prior therapies per investigator assessment likely to interfere with the assessments of safety or efficacy of the study treatment.\n* History of a severe immediate hypersensitivity reaction or contraindication to any of the agents used in the study (including fludarabine and cyclophosphamide).\n* Live vaccine ≤ 6 weeks before randomization, during the treatment period, and until immune recovery following the study treatments (refer to Section 12.10 for additional country-specific requirements, as applicable).\n* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.\n* Individuals of either sex who are not willing to practice highly effective birth control from the time of informed consent through 12 months after the completion of KITE-753 or axi-cel infusion.\n* In the investigator's judgment, the individual is unlikely to complete all study-specific visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":56,"type":20},550,[58],"PHASE3","The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r\u002Fr) large B-cell lymphoma (LBCL) after one prior line of therapy.\n\nThe primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.",[26],"RECRUITING","2026-06-15",{"date":64,"type":39},"2026-06-16",{"date":66,"type":39},"2026-05-22",{"date":68,"type":20},"2031-05",{"name":70,"class":71},"Kite, A Gilead Company","INDUSTRY",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":47},"100576720","phase-2-loncastuximab-tesirine-and-rituximab-as-bridging-therapy-before-standard-of-care-car-t-therapy-in-patients-with-large-b-cell-lymphoma-coral-100576720","NCT06788964","Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)","A Phase 2 Study of Loncastuximab Tesirine and Rituximab as Bridging Therapy Prior to Standard-of-care CD19 CAR T-cell Therapy in Patients With Large B-cell Lymphoma","CORAL","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* Intended to receive commercial CD19-directed CAR-T cell therapy (axi-cel and liso-cel).\n* Need for bridging therapy as deemed clinically necessary by the treating physician.\n* Relapsed or refractory DLBCL, tFL or PMBCL as defined by the 2016 World Health Organization classification (including patients with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma (HGBL), not otherwise specified, and HGBL with MYC and BCL2 and\u002For BCL6 rearrangements.\n\n  --Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen.\n* Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT.\n* ECOG Performance Status ≤ 2.\n* Time between prior anticancer therapy and first dose of lonca-R as below\n\n  * Autologous hematopoietic cell transplantation - At least 30 days\n  * Allogeneic hematopoietic cell transplantation - At least 60 days\n  * Cytotoxic chemotherapy - At least 21 days\n  * Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n    * Platelet count ≥ 75,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    * Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and\u002F or Gilbert's disease\n    * Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 60 mL\u002Fmin by Cockcroft-Gault formula.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.41.1 and 5.4.2.\n* Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.\n* Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n* Previous treatment with any anti-CD19 therapy including lonca or prior CD19 CAR T-cell therapy\n* Subjects receiving investigational CAR-T products\n* Major surgery within 4 weeks prior to starting study therapy.\n* History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.\n* Subjects with chronic liver disease with hepatic impairment Child-Pugh class C\n* Pregnant or lactating or intending to become pregnant during the study\n* Active graft-versus-host disease\n* Post-transplantation lymphoproliferative disorders\n* Active autoimmune disease which, in the opinion of the investigator, may negatively impact subject safety or interfere with study participation.\n* The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or interfere with study participation.\n* Subjects with known CNS involvement.\n* Significant medical diseases or conditions including those requiring substantial changes in concomitant medications, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Myocardial infarction (MI) within 6 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 480 ms.\n    * Congenital long QT syndrome or a corrected QT measure (QTc) interval of \\>480 ms at screening (unless secondary to pacemaker or bundle branch block).\n  * Severe pulmonary disease\n  * Uncontrolled diabetes mellitus\n  * Severely immunocompromised state\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening\n* HIV infection.\n* Subjects with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Subjects who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing. Subjects with active Hep C patients may be enrolled if other parameters precluding hepatic impairment are met and they are not undergoing active therapy for hepatitis C.\n* Known prior severe hypersensitivity to a CD19 antibody, lonca (including SG3249) or any of its excipients, or history of positive serum human ADA to a CD19 antibody.\n* Subjects taking prohibited medications as described in Section 6.8.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.",{"count":82,"type":20},29,[84],"PHASE2","The purpose of this clinical trial is to learn if the study treatment Loncastuximab tesirine and Rituximab is safe and efficient before standard of care chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory large B-cell lymphoma.",[26],"2026-05-27",{"date":89,"type":39},"2026-05-29",{"date":91,"type":39},"2025-08-25",{"date":93,"type":20},"2030-03",{"name":95,"class":46},"University of Utah"]