[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kite, A Gilead Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":148},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,66,89,106,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100616326","phase-1-a-study-evaluating-the-safety-and-efficacy-of-kite-363-in-relapsedrefractory-autoimmune-neurologic-diseases-100616326",false,"NCT07304154","A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed\u002FRefractory Autoimmune Neurologic Diseases","A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19\u002FCD20 CAR T-cell Therapy in Participants With Relapsed\u002FRefractory Autoimmune Neurologic Diseases","Key Inclusion Criteria:\n\n* Reproductive status-related eligibility and contraception requirements:\n\n  * Participants must agree to use protocol-specified method(s) of contraception where applicable\n\nInclusion Criteria for multiple sclerosis (MS):\n\nMS (Relapsing and progressive forms):\n\n* Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria\n\nRelapsing forms of MS (relapsing-remitting multiple sclerosis (RRMS), active secondary-progressive multiple sclerosis (aSPMS)):\n\n* Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effects prohibiting the chronic use of the DMT.\n* Expanded Disability Status Scale (EDSS) 0 to 5.5\n\nProgressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active secondary-progressive multiple sclerosis (naSPMS)):\n\n* Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care therapy for naSPMS or despite ocrelizumab, where available, for PPMS\n* Absence of clinical relapses for at least 24 months\n* No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline\n* EDSS of 3 to 6.5 who are ambulatory\n\nInclusion Criteria for myasthenia gravis (MG):\n\n* Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)\n* Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening\n* Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\\> 50% of the total score due to non-ocular symptoms)\n* Quantitative Myasthenia Gravis (QMG) score ≥ 10\n* Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg, rituximab, anti-neonatal fragment crystallizable (Fc) receptor (FcRN) class, and anti-complement class))\n* Thymectomy allowed if completed ≥ 12 months prior to screening\n\nInclusion Criteria for chronic inflammatory demyelinating polyneuropathy (CIDP):\n\n* Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies\u002FPeripheral Nerve Society (EFNS\u002FPNS) criteria, relapsing or progressive forms\n* CIDP Disease Activity Status (CDAS) score ≥ 3 at screening\n* Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3\n* Inadequate response to previous therapies despite standard of care therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN) OR Unable to tolerate standard of care due to side effects with ongoing disease activity\n* Except for nodal\u002Fparanodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24 months when IVIg, SCIg, PLEX, or anti-FcRN has been reduced or interrupted\n\nKey Exclusion Criteria:\n\n* History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or cause weakness\n* History of autologous or allogeneic stem cell transplant and\u002For organ transplant\n\nExclusion Criteria for MS:\n\n* Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in \\\u003C 240 seconds and Timed 25 foot Walk (T25FW) \\\u003C 150 seconds\n* History of hypersensitivity to parenteral administration of gadolinium-based contrast agents\n* Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)\n* Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS)\n\nExclusion Criteria for MG:\n\n* Current myasthenic crisis not effectively controlled within 2 weeks before enrollment\n* Thymectomy performed within 12 months of baseline\n\nExclusion Criteria for CIDP:\n\n* Pure sensory CIDP and focal CIDP\n* Polyneuropathy of other causes\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","75 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed\u002Frefractory autoimmune neurologic diseases.\n\nThe primary objectives of this study are:\n\n* To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases\n* To determine the recommended dose for Phase 1b.\n* To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.",[27,28,29],"Chronic Inflammatory Demyelinating Polyneuropathy","Myasthenia Gravis","Multiple Sclerosis","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2026-04-10",{"date":38,"type":21},"2029-06",{"name":40,"class":41},"Kite, A Gilead Company","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100438478","phase-1-study-of-kite-363-or-kite-753-in-participants-with-relapsed-andor-refractory-b-cell-lymphoma-100438478","NCT04989803","Study of KITE-363 or KITE-753 in Participants With Relapsed and\u002For Refractory B-cell Lymphoma","A Phase 1\u002F2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19\u002FCD20 CAR T-cell Therapies, in Subjects With Relapsed and\u002For Refractory B-cell Lymphoma","PALISADES-1","Key Inclusion Criteria: for Phase 1a\u002Fb and Phase 2\n\n* Relapsed and\u002For refractory B-cell lymphoma (R\u002FR BCL).\n* At least 1 measurable lesion.\n* Adequate organ and bone marrow (BM) function.\n\nKey Exclusion Criteria: for Phase 1a\u002Fb and Phase 2\n\n\\- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.\n\n* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.\n* History of allogeneic stem cell transplant (allo-SCT).\n* Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.\n* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.\n* Known history of human immunodeficiency virus (HIV) infection, 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.\n* Individuals with suspicion and\u002For evidence of primary or secondary CNS lymphoma.\n* History or presence of a CNS disorder.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active 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* Primary immunodeficiency.\n* History of autoimmune disease resulting in or requiring systemic immunosuppression and\u002For systemic disease-modifying agents within the last 90 days.\n* Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and\u002For transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.\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\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":51,"type":21},247,[24,53],"PHASE2","The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and\u002For refractory B-cell lymphoma.",[56],"Relapsed and\u002For Refractory B-cell Lymphoma","2026-06-26",{"date":59,"type":34},"2026-06-29",{"date":61,"type":34},"2021-10-27",{"date":63,"type":21},"2030-02",{"name":40,"class":41},26,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"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":74,"type":21},550,[76],"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.",[79],"Relapsed or Refractory Large B-cell Lymphoma","2026-06-15",{"date":82,"type":34},"2026-06-16",{"date":84,"type":34},"2026-05-22",{"date":86,"type":21},"2031-05",{"name":40,"class":41},2,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":104,"locationsCount":105},"100498892","expanded-access-study-for-the-treatment-of-patients-with-commercially-out-of-specification-axicabtagene-ciloleucel-100498892","NCT05776160","Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel","Inclusion Criteria:\n\n* Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)\n* Deemed medically fit and stable to receive the product per the investigator's evaluation\n* Repeat leukapheresis is not feasible per the investigator's assessment\n* Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release\n* In the investigator's opinion, there is no satisfactory alternative therapy available to the individual\n\nExclusion Criteria:\n\n* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel\n* Uncontrolled active infection or inflammation per physician assessment\n* Primary central nervous system lymphoma","EXPANDED_ACCESS","The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.",[98,99],"Large B-cell Lymphoma","Follicular Lymphoma","AVAILABLE","2026-06-11",{"date":103,"type":34},"2026-06-12",{"name":40,"class":41},128,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100547863","phase-3-a-study-comparing-anitocabtagene-autoleucel-to-standard-of-care-therapy-in-participants-with-relapsed-refractory-multiple-myeloma-100547863","NCT06413498","A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed\u002F Refractory Multiple Myeloma","A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed\u002FRefractory Multiple Myeloma","iMMagine-3","Key Inclusion Criteria:\n\n* Documented historical diagnosis of multiple myeloma (MM)\n* Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.\n* Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen\n* Measurable disease at screening per IMWG, defined as any of the following:\n\n  * Serum M-protein level ≥ 0.5 g\u002FdL or urine M-protein level ≥ 200 mg\u002F24 hours; or\n  * Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg\u002FdL and abnormal serum free light chain ratio\n* Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL (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\nKey Exclusion Criteria:\n\n* Prior B-cell maturation antigen (BCMA)-targeted therapy\n* Prior T-cell engager therapy\n* Prior CAR therapy or other genetically modified T-cell therapy\n* Active or prior history of central nervous system (CNS) or meningeal involvement of MM\n* Cardiac atrial or cardiac ventricular MM involvement\n* History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis\n* Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.\n* Prior auto-SCT within 12 weeks before randomization\n* Prior allogeneic stem cell transplant (allo-SCT)\n* High-dose (eg, cumulative \\> 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization\n* Live vaccine ≤ 4 weeks before randomization\n* Contraindication to fludarabine or cyclophosphamide\n* History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.\n* Life expectancy \\\u003C 12 weeks\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":115,"type":21},450,[76],"The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed\u002Frefractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.\n\nThe primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.",[119],"Multiple Myeloma",[119,121,122,123],"CAR-T","ddBCMA","BCMA","2026-05-05",{"date":126,"type":34},"2026-05-07",{"date":128,"type":34},"2024-08-23",{"date":130,"type":21},"2031-07",{"name":40,"class":41},124,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":146,"locationsCount":147},"100498890","expanded-access-study-for-the-treatment-of-patients-with-commercially-out-of-specification-brexucabtagene-autoleucel-100498890","NCT05776134","Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel","Inclusion Criteria:\n\n* Have commercially manufactured brexucabtagene autoleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)\n* Deemed medically fit and stable to receive the product per the investigator's evaluation\n* Repeat leukapheresis is not feasible per the investigator's assessment\n* Be diagnosed with 1 of the approved labeled indications for brexucabtagene autoleucel that is intended for release\n* In the Investigator's opinion, there is no satisfactory alternative therapy available to the individual\n\nExclusion Criteria:\n\n* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as brexucabtagene autoleucel\n* Uncontrolled active infection or inflammation per physician assessment\n* Primary central nervous system (CNS) lymphoma","The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.",[141,142],"Mantle Cell Lymphoma","Acute Lymphoblastic Leukemia","2026-04-07",{"date":145,"type":34},"2026-04-08",{"name":40,"class":41},44,""]