[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marcela V. Maus, M.D.,Ph.D.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":179},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,67,99,126,153],{"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":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100622796","phase-1-cc-97540-in-patients-with-antineutrophil-cytoplasmic-antibody-associated-vasculitis-100622796",false,"NCT07388277","CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis","A Phase I\u002FII Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis","Inclusion Criteria:\n\n* Able to voluntarily provide written informed consent prior to the performance of any study-specific procedures.\n\n  -≥18 years of age at the time of signing informed consent.\n* Classification as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) per the American College of Rheumatology (ACR) \u002F European Alliance of Associations for Rheumatology (EULAR) 2022 definitions (Robson et al., 2022, Suppiah et al., 2022) (see Appendix A).\n* Current or historical positive proteinase 3 (PR3) or myeloperoxidase (MPO) antibody testing or a cytoplasmic (cANCA) or perinuclear antineutrophil cytoplasmic antibody (pANCA) immunofluorescence pattern. (Antibodies and immunofluorescence may currently be negative.)\n* Active ANCA-associated vasculitis within 6 weeks of screening presenting as either:\n* Relapsed disease (BVASv3 \\> 0 following prior remission) despite standard-of-care treatment per the ACR\u002FVasculitis Foundation (VF) Guidelines for the Management of ANCA-Associated Vasculitis (Chung et al., 2021), or\n* Refractory disease (persistent BVASv3 positivity) despite standard-of-care treatment per the ACR\u002FVF Guidelines (Chung et al., 2021). Refractory disease is defined as persistent BVASv3 positivity despite at least 6 weeks of appropriate guideline-indicated standard-of-care treatment per the ACR\u002FVF Guidelines for the Management of ANCA-Associated Vasculitis.\n\nAppropriate guideline-indicated standard-of-care treatment per the ACR\u002FVF Guidelines for the Management of ANCA-Associated Vasculitis includes:\n\n* either rituximab or cyclophosphamide for severe disease;\n* or, methotrexate or azathioprine for non-severe disease.\n\n  -Severe disease activity defined as:\n* 1 or more major BVAS\u002FWG criteria or at least 3 minor BVASv3 items (see Appendix B), or\n* 1 or more of cutaneous ulceration, retroorbital disease, sinonasal disease with bony or cartilage damage, subglottic stenosis, or renal involvement, or\n* Unanimous expert committee consensus on severity (3\u002F3 agreement).\n\n  * Left ventricular ejection fraction \\> 45%.\n  * Adequate hepatic function defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\\u003C2.5 × upper limit of normal (ULN) and direct bilirubin \\\u003C1.5 × ULN. Elevation in bilirubin attributable to Gilbert's syndrome is permitted.\n  * Adequate renal function defined by creatinine clearance \\>30 ml\u002Fmin using the Cockcroft-Gault formula. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated. For select subjects, including those with short stature or low lean muscle mass, alternative calculators to Cockcroft-Gault such as Modification in Diet Renal Disease (MDRD), Chronic Kidney Disease Epidemiology (CKD-EPI), or Cystatin C measurements may be used.\n  * Absolute lymphocyte count of ≥ 300 cells\u002FuL.\n  * Adequate organ function defined as:\n* Hemoglobin ≥ 8 g\u002FdL\n* Platelet count ≥ 75,000\u002FuL\n\n  * Willingness to adhere to contraceptive requirements. The effects of CC-97540 CAR T cells on the developing human fetus are unknown. Lymphodepleting chemotherapy poses genotoxic, fetotoxic, and infertility risks. For these reasons, women of child-bearing potential and men with partners of childbearing potential must use effective contraception beginning prior to leukapheresis and continuing for at least 12 months after CC-97540 infusion. Due to potential unknown interactions of CC-97540 with hormonal contraception, an additional barrier method should be used if hormonal contraception is chosen. Participants who become pregnant or suspect pregnancy during the study must notify the treating physician immediately.\n  * Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n* Current or historical positivity for a glomerular basement membrane antibody.\n* ANCA-associated vasculitis deemed drug-induced or cocaine\u002Flevamisole-associated.\n* Treatment of relapsing disease with rituximab or other B cell-depleting therapy for the current episode of relapsed vasculitis. Prior rituximab use for a prior episode (flare) of vasculitis activity is permitted.\n* Parkinson's disease, epilepsy, aphasia, cerebellar disease.\n* Prior organ transplant currently requiring an immunosuppressive regimen.\n* Active malignancy requiring treatment other than non-metastatic basal cell or squamous cell skin carcinoma.\n* Treatment with any prior CAR T cell therapy.\n* Significant comorbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study.\n* Active, uncontrolled, systemic bacterial, viral, or fungal infection.\n* Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.\n* Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.\n* Subjects with high bleeding risk including INR or PTT greater than 1.5 times the upper limit of normal unless due to a stable dose of anticoagulation. Ongoing anticoagulation permitted if a stable regimen.\n* Absolute neutrophil count \\\u003C 500 cells\u002FuL.\n* Symptomatic cerebrovascular disease or peripheral vascular arterial disease requiring ongoing therapeutic anticoagulation or dual antiplatelet therapy or other vascular disease not allowing for holding of DAPT.\n* Subjects with a history of pulmonary embolism (PE) or deep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.\n* Pregnant or lactating women. Pregnant women are excluded from this study because CC-97540 CAR T cell drug products are agents with the potential for adverse effects for a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CC-97540 T cell drug products, breastfeeding should be discontinued if the mother is treated with CC-97540 CAR T cell drug product.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety of CC-97540 in relapsed or refractory severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.",[27],"Antineutrophil Cytoplasmic Antibody-associated Vasculitis",[29],"Refractory\u002FRelapsing ANCA-associated vasculitis","RECRUITING","2026-05-13",{"date":33,"type":34},"2026-05-15","ACTUAL",{"date":36,"type":20},"2026-07-09",{"date":38,"type":20},"2029-12-31",{"name":40,"class":41},"Marcela V. Maus, M.D.,Ph.D.","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100440833","phase-1-tripril-car-t-cells-in-multiple-myeloma-100440833","NCT05020444","TriPRIL CAR T Cells in Multiple Myeloma","A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document.\n* Age ≥18 years at the time of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Life expectancy of greater than 12 weeks\n* Histologically or cytologically confirmed diagnosis of relapsed\u002Frefractory multiple myeloma. Documented measurable disease includes at least one or more of the following criteria:\n\n  * Serum M-protein ≥1.0 g\u002FdL\n  * Urine M-protein ≥200 mg\u002F24 hours\n  * Involved serum free light chain ≥100 mg\u002FL with abnormal κ\u002Fλ ratio\n  * Bone marrow plasma cells ≥30%\n* Relapsed\u002Frefractory multiple myeloma with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody; or has \"triple-refractory\" disease following treatment with proteasome inhibitor, IMiD and anti-CD38 antibody, as part of the same or different regimens.\n\nNote: IMWG criteria defines refractory disease as disease progression on or within 60 days of receiving a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen.\n\n* Adequate organ and marrow function as defined below:\n\n  * O2 saturation ≥92% on room air while awake\n  * LVEF ≥40% by ECHO or MUGA scan\n  * ANC ≥1.0k\u002Fμl, PLT ≥50k\u002Fμl, (NOTE: Platelet transfusion not allowed within 7 days; growth factor neupogen not allowed within 7 days, neulasta within 14 days)\n  * Creatinine clearance ≥30 mL\u002Fmin and not on dialysis\n  * AST\u002FALT \\\u003C3 x ULN\n  * Direct bilirubin \\\u003C1.5 x ULN (allow x 3 ULN for Gilbert's syndrome)\n  * PTT, PT\u002FINR \\\u003C1.5 x ULN, unless on a stable dose of anti-coagulant for a thromboembolic event (Patients with any history of thromboembolic stroke; or history or Grade 2 or greater hemorrhage within 60 days are excluded)\n* Resolution of AEs from any prior therapy to ≤ Grade 1 (≤ G2 alopecia and ≤ G2 sensory neuropathy are allowed, cytopenias allowed per eligibility criteria above)\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* The effects of TriPRIL CAR T cells on the developing human fetus are unknown. Male and female participants of childbearing potential must agree to use highly effective methods of birth control prior to study entry, for the duration of study participation, and through 6 months after completion of TriPRIL CAR T cells administration. 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.\n\nNOTE: Highly effective contraception methods include:\n\n* Total abstinence\n* Female sterilization (tubal ligation, bilateral oophorectomy, and\u002For hysterectomy)\n* Male sterilization, at least 6 months prior to screening\n* Intrauterine device\n* Oral, injected, or implanted hormonal contraception AND barrier methods of contraception\n\n  * Willing to comply with and able to tolerate study procedures, including Long-term Safety Follow-up lasting up to 15 years per FDA guidance\n\nExclusion Criteria:\n\n* Treatment with any of the following therapies as specified below:\n\n  * Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis unless discussed with the medical monitor\n  * Receiving high-dose (e.g., \\>10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis\n  * Autologous stem cell transplantation within 3 months prior to leukapheresis\n  * Any prior allogeneic stem cell transplantation\n  * Other CAR-T cell therapy within 6 months of leukapheresis\n* Plasma cell leukemia or history of plasma cell leukemia\n* Patients with extramedullary disease only without meeting criteria for measurable disease as per inclusion criteria above.\n* No Bispecific T cell engagers withing 6 months of apheresis\n* No bendamustine within 6 months of apheresis\n* Patients with solitary plasmacytomas without evidence of other measurable disease\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CAR- T cells\n* Contraindication to the protocol-specified doses of fludarabine or cyclophosphamide\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of ≤ G2 alopecia and grade ≤2 sensory neuropathy.\n* Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, e.g., related to disease)\n* Symptomatic congestive heart failure\n* Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to screening\n* Significant pulmonary dysfunction\n* Auto-immune disease requiring immunosuppressive therapy\n* Pulmonary embolism or DVT within three months of enrollment or uncontrolled thromboembolic events. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of DVT or PE if greater than three months from time of enrollment. Prophylactic anticoagulation is allowed.\n* Recent severe hemorrhage (within the past 60 days)\n* Seropositive for and with evidence of active hepatitis B or C infection at time of screening, or HIV seropositive\n\n  * Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA for 6 months are eligible\n  * Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible\n  * Subjects who had hepatitis C but have received antiviral therapy and show no detectable HCV viral RNA for 6 months are eligible\n* Active central nervous system (CNS) involvement by malignancy. NOTE: subjects who are asymptomatic, stable, and received prior effective treatment for CNS disease may be eligible after discussion with the medical monitor.\n* Any sign of active or prior CNS pathology including history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease, organic brain syndrome or psychosis.\n* Active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the medical monitor.\n* Females who are pregnant or breastfeeding or females of childbearing potential not using an effective method of birth control\n* Subjects with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in study (or full access to medical records) as written including follow up, the interpretation of data or place the subject at unacceptable risk\n* Participants taking any other medicine concurrently that may interfere with the study (need to consult with the principle investigator)",{"count":51,"type":20},18,[23],"This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells.\n\nThis research study involves the study drugs:.\n\n* TriPRIL CAR T Cells\n* Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process",[55,56,57],"Multiple Myeloma","Multiple Myeloma in Relapse","Refractory Multiple Myeloma",[55,56,57],"2026-05-08",{"date":61,"type":34},"2026-05-12",{"date":63,"type":34},"2021-10-05",{"date":65,"type":20},"2028-02-24",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":42},"100518113","phase-1-cd79b-19-car-t-cells-in-non-hodgkin-lymphoma-100518113","NCT06026319","CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma","A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Voluntarily sign informed consent form(s)\n* ≥18 years of age at the time of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* Diagnosis of histologically or cytologically confirmed relapsed\u002Frefractory (R\u002FR) Non Hodgkins lymphoma as defined as one of the following (Note: only patients with indolent lymphomas that warrant treatment should be treated, this will include those with local symptoms due to progressive\u002Fbulky disease, compromised organ function, B symptoms, extra-nodal disease, cytopenias from marrow involvement and\u002For in the opinion of the treating physician believe that any of the above symptoms or potentially life threatening involvement will occur will be treated):\n\n  1. Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  2. Marginal Zone Lymphoma (MZL) nodal of extranodal:\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  3. Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL).\n\n     1. R\u002FR disease after 2 or more prior lines of therapy OR\n     2. Relapsed following autologous SCT, OR\n     3. Ineligible for autologous SCT.\n  4. Mantle cell lymphoma\n\n     1. R\u002FR disease as defined by disease progression after last regimen (including autologous SCT) OR\n     2. Refractory disease as defined as failure to achieve a CR to last regimen.\n     3. Prior therapy must include:\n\n        * Anthracycline or bendamustine-containing chemotherapy AND\n        * Anti-CD20 monoclonal antibody therapy AND\n        * BTKi therapy (progression does not have to be documented on BTKi).\n* Subjects must have measurable disease according to appropriate disease specific criteria.\n* Adequate absolute lymphocyte count (ALC \\> 100 cells\u002Ful) within one week of apheresis.\n* Adequate bone marrow function defined by absolute neutrophil count (ANC) \\>1000 cells\u002Fmm3 without growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days) and untransfused platelet count \\>50,000 mm3.\n* Left ventricular ejection fraction \\> 40%\n* Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 × upper limit of normal (ULN) and direct bilirubin \\\u003C 1.5 × ULN.\n* Adequate renal function defined by creatinine clearance \\>60 ml\u002Fmin using the Cockcroft-Gault formula.\n* The effects of CD79b-19 CAR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis. Women of childbearing potential are required to use adequate contraception for up to 1 year post CD79b-19 CAR T cell infusion. 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. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 6 months after last CD79b-19 CAR T cells administration.\n* Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nInclusion Criteria for treatment (Initiating Lymphodepletion\u002FCell Infusion):\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* No active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must have negative blood cultures x48 hours at time of cell infusion AND on appropriate broad spectrum antibiotic therapy\n* Oxygen saturation \\>92% on room air while awake\n* No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.\n\nInfusion may be delayed by up to 5 days after completion of LD chemo, without sponsor approval, in the event that these issues resolve in that time frame.\n\nThe above criteria need to be met to start treatment (for both initiation of lymphodepletion and cell infusion).\n\nExclusion Criteria for Leukapheresis for Parts A and B:\n\n* Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.\n* Any systemic anti-cancer therapy within 1 weeks or 5 half-lives of leukapheresis, whichever is shortest, excluding steroids (prednisone) at or below physiologic dosing (5mg).\n* No bispecific T cell engagers within 6 months of leukapheresis.\n* No bendamustime within 6 months of leukapheresis.\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.\n* Ongoing systemic immunosuppression for acute and\u002For chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.\n* Presence of active CNS disease\n* Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and\u002For recent significant traumatic injury.\n* Active, uncontrolled, systemic bacterial, viral, or fungal infection.\n* Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.\n* Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.\n* Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.\n* Subjects with history of a new pulmonary embolism (PE) \u002Fdeep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.\n* Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.\n* Pregnant or lactating women. Pregnant women are excluded from this study because CAR-79b-19 T cell drug product is an agent with 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 CAR-79b-19 T cell drug product, breastfeeding should be discontinued if the mother is treated with CAR-79b-19 T cell drug product.\n\nAdditional Exclusion Criteria for Leukapheresis for Part B, Arm B.2:\n\n* Prior CD19-directed cellular therapy.",{"count":75,"type":20},24,[23],"This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed\u002Frefractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells.\n\nThis research study involves the study drugs:\n\n* CD79b-19 CAR T cells\n* Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process",[79,80,81,82,83,84,85,86,87,88],"Non-hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Diffuse Large B Cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","High-grade B-cell Lymphoma","Grade 3b Follicular Lymphoma","Mantle Cell Lymphoma",[90],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-13",{"date":93,"type":34},"2026-03-16",{"date":95,"type":34},"2023-10-26",{"date":97,"type":20},"2028-01-01",{"name":40,"class":41},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":117,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":42},"100441118","long-term-follow-up-of-subjects-treated-with-car-t-cells-100441118","NCT05024175","Long-term Follow-up of Subjects Treated With CAR T Cells","Inclusion Criteria:\n\nSubjects will be asked to participate leading up to the last DF\u002FHCC corresponding main study visit.\n\nSubjects meeting the following criteria are eligible for study participation:\n\n* Provision of voluntary written informed consent by subject\n* CAR T cells were administered in DF\u002FHCC IRB corresponding main study\n\nExclusion Criteria:\n\nSubjects meeting the following criterion are to be excluded from study participation:\n\n\\- Subject unable to comply with study requirements",{"count":106,"type":20},45,"OBSERVATIONAL","This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for Phase 1 studies that evaluate the safety and efficacy of CAR T cells: NCT05660369 (DF\u002FHCC# 22-175) and NCT06026319 (DF\u002FHCC# 23-474).",[110,111,112,113,114,115,116],"Long Term Adverse Effects","CAR-T","Duty to Follow Up","Adult","Progression-Free Survival","Disease-Free Survival","Overall Survival",[118,119],"Long-Term Follow-up to CAR-T Cells","Follow-up Studies",{"date":93,"type":34},{"date":122,"type":34},"2023-08-07",{"date":124,"type":20},"2039-08-01",{"name":40,"class":41},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":42},"100489995","phase-1-carv3-team-e-t-cells-in-glioblastoma-100489995","NCT05660369","CARv3-TEAM-E T Cells in Glioblastoma","INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM","Inclusion Criteria:\n\n* Safety Run In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant\n\n  * Participants must have histologically confirmed recurrent GBM or molecular features of GBM with presence of EGFRvIII mutation detected at initial diagnosis. MGMT methylated, unmethylated, or unknown is allowed.\n  * Participants must be at first progression or recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.\n\nParticipants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent before proceeding with collection or treatment. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.\n\n* ARM 2: Newly Diagnosed GBM, EGFRvIII mutant (will only open once safety is confirmed in Arms 1 and 3)\n\n  * Participants must have histologically confirmed newly diagnosed GBM with presence of EGFRvIII mutation and their tumors must be MGMT unmethylated.\n  * Treatment planned with involved field radiation alone without concomitant or sequential temozolomide.\n* ARM 3: Recurrent GBM, EGFRvIII negative\n\n  * Participants must have histologically confirmed recurrent GBM with EGFR amplification but no EGFRvIII mutation based on initial diagnostic tissue.\n  * Participants must be at first recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.\n\nParticipants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.\n\n* ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:\n\n  * Must be at least 3 months from completion of radiation or evidence of progression is outside the high dose radiation field.\n* Safety Run-In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:\n\n  * Participants must have measurable disease, defined as at least one lesion ≥10 mm (≥1 cm) with MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.\n* ALL ARMS:\n\n  * Patients cannot have posterior fossa or intramedullary spine-only disease. Leptomeningeal disease is allowed anywhere in the neuroaxis. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.\n  * Resolution of AEs from any prior systemic anticancer therapy or radiotherapy to Grade 1 or baseline (except Grade 2 alopecia and Grade 2 sensory neuropathy)\n  * Medically able and willing to undergo placement of an Ommaya reservoir.\n  * Steroid dose anticipated to be ≤ 4 mg of dexamethasone a day or equivalent at time of first CAR-v3-TEAM-E infusion.\n  * Age ≥18 years\n  * Karnofsky ≥60%\n  * Must be able to undergo an MRI with contrast.\n  * Life expectancy of greater than 3 months.\n  * Participants must have adequate organ and marrow function as defined below:\n\n    * Absolute neutrophil count ≥1,000\u002FmcL\n    * Platelets ≥80,000\u002FmcL\n    * Total bilirubin ≤ institutional upper limit of normal (ULN); For patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.\n    * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n    * CrCl ≥ 60 mL\u002Fmin\n  * Participant has no prior history of malignancy, unless the subject has been free of the disease for ≥5 years with the exception of the following noninvasive malignancies:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative\n  * Left ventricular ejection fraction \\>50% as determined by TTE.\n  * The effects of CARv3-TEAM-E on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 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. 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 CARv3-TEAM-E administration.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Intraparenchymal posterior fossa disease\n* Intramedullary spinal disease as the only site of disease.\n* Prior EGFRvIII targeted therapies.\n* Prior bevacizumab treatment.\n* Treatment with an any prior gene-therapy or gene-modified cellular therapy.\n* Patients with a VP shunt or patients needing a shunt in the immediate future are excluded from participating\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed\n* Participants who have not recovered from adverse events 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* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CARv3-TEAM-E (ex. cetuximab).\n* Participants with uncontrolled intercurrent illness.\n* Human immunodeficiency virus (HIV)-infected participants are not eligible.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection or active hepatitis C virus (HCV) infection are not eligible.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CARv3-TEAM-E , breastfeeding should be discontinued if the mother is treated with CARv3-TEAM-E.\n* For Arm 2, prior to CARv3-TEAM-E Infusion, the following criteria should be confirmed in addition to the relevant criteria above:\n\n  * Participants must have completed 75% of the planned 6 weeks of involved field radiation without temozolomide\n  * Tumor location and size criteria as in 3.1.7 above.\n  * Prior cancer directed therapy other than radiation is not allowed.",{"count":134,"type":20},21,[23],"The goal of this research study is to determine the best dose of CARv3-TEAM-E T Cells for treating participants with glioblastoma.\n\nThe name of the treatment intervention used in this research study is:\n\n-CARv3-TEAM-E T Cells (or Autologous T lymphocytes).",[138,139,140,141],"Glioblastoma","Malignant Glioma","Recurrent Glioblastoma","Recurrent Glioma",[138,139,140,141,143,144],"Immunotherapy","Gene-Transfer Therapy","2026-02-02",{"date":147,"type":34},"2026-02-04",{"date":149,"type":34},"2023-03-22",{"date":151,"type":20},"2027-09-01",{"name":40,"class":41},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100558363","phase-2-emapalumab-prevention-of-car-t-cell-associated-toxicities-100558363","NCT06550141","Emapalumab Prevention of CAR-T Cell Associated Toxicities","A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities","Inclusion Criteria:\n\n* Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Or adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.\n* At least 1 measurable lesion per Lugano at time of screening.\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy however steroids only require a 7-day washout.\n* At least 3 half-lives must have elapsed from any prior systemic inhibitory\u002Fstimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc).\n* Age 18 or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n  * ANC ≥1000\u002FuL\n  * Platelet count ≥50,000\u002FuL\n  * Absolute lymphocyte count ≥100\u002FuL\n  * Creatinine clearance (as estimated by Cockcroft Gault or CKD-EPI) ≥ 30 mL\u002Fmin\n  * Serum ALT\u002FAST ≤2.5 per institutional ULN\n  * Total bilirubin ≤1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n  * Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion, and no clinically significant ECG findings\n  * Baseline oxygen saturation \\>92% on room air.\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* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.\n* History of Richter's transformation of CLL.\n* Autologous stem cell transplant within 6 weeks of planned axicabtagene ciloleucel infusion.\n* History of allogeneic stem cell transplantation.\n* Presence of uncontrolled fungal, bacterial, viral, or other infection at time of screening.\n* Known history of acute or chronic active hepatitis B or C infection. Subjects 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 (IDSA) guidelines.\n\n  * Patients should also be negative for latent Tb, CMV (NAT), EBV (NAT) and adenovirus (NAT) by PCR testing.\n* No evidence of active CNS disease regardless of prior CNS history.\n* History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage within 6 months of enrollment.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n* History of symptomatic pulmonary embolism within 3 months of enrollment; ongoing anticoagulation is allowed if beyond 3 months.\n* Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n* History of allergic reactions or severe immediate hypersensitivity reaction to any of the agents used in this study or compounds of similar chemical or biologic composition.\n* Females who are pregnant or breastfeeding or female or male participants who are not willing to practice birth control from the time of consent through 6 months after the completion of axicabtagene ciloleucel\n* In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* History of autoimmune disease requiring ongoing systemic immunosuppression. Steroids are allowed up to 5mg predinosine-equivalent for adrenal insufficiency.\n* Patients anticipated to require canakinumab, JAK inhibitors, TNF inhibitors, and tocilizumab for non-CAR-T management of baseline autoimmune\u002Finflammatory disease at the time of emapalumab initiation.\n* Receipt of a BCG vaccine within 12 weeks prior to Screening.\n* Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screeing.\n* Participants who are receiving any other investigational agents for this condition.",{"count":161,"type":20},28,[24],"This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).\n\nThe research study involves the following study interventions:\n\n* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)\n* Axicabtagene Ciloleucel\n* Emapalumab",[165,80,81,84,166,86,82],"Large B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma",[168,169],"Second Line Large B-cell Non-Hodgkin's Lymphoma","Third Line Large B-cell Non-Hodgkin's Lymphoma","2025-11-12",{"date":172,"type":34},"2025-11-14",{"date":174,"type":34},"2024-09-18",{"date":176,"type":20},"2027-08-01",{"name":40,"class":41},2,""]