[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Juno Therapeutics, a Subsidiary of Celgene\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100311193","phase-1-study-evaluating-safety-and-efficacy-of-jcar017-in-subjects-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-or-small-lymphocytic-lymphoma-sll-100311193",false,"NCT03331198","Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)","An Open-Label, Phase 1\u002F2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)","Inclusion Criteria:\n\n* Diagnosis of:\n\n  1. CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or\n  2. SLL (lymphadenopathy and\u002For splenomegaly and \\\u003C 5×10\\^9 CD19+ CD5+ clonal B lymphocytes\u002FL \\[\\\u003C 5000\u002FµL\\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)\n* Subjects (other than those in the ibrutinib + JCAR017 combination therapy and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.\n* Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:\n\n  1. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.\n  2. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.\n  3. DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i.\n* Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:\n\n  1. be receiving ibrutinib and progressing at the time of study enrollment\n  2. be receiving ibrutinib for at least 6 months with a response less than complete response\u002Fremission (CR) and have high-risk features as defined in inclusion criterion 5a\n  3. have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib\n  4. have previously received ibrutinib and have no contraindications to restarting ibrutinib\n* Eastern Cooperative Oncology Group performance status of ≤ 1\n* Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy\n* Adequate organ function, defined as:\n\n  1. Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance \\> 30 mL\u002Fmin\n  2. Alanine aminotransferase ≤ 5 × ULN and total bilirubin \\\u003C 2.0 mg\u002FdL (or \\\u003C 3.0 mg\u002FdL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)\n  3. Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air\n  4. Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility\n* Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.\n* If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.\n* Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax\n* Subjects in venetoclax + JCAR017 combination cohort must:\n\n  1. have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi\n  2. be venetoclax naive (required for dose expansion) or\n  3. if prior venetoclax (only for dose escalation)\n  4. have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation\n* subjects in the venetoclax + JCAR017 combination must have hemoglobin \\>=9 g\u002FdL, absolute neutrophil count \\>=500mm3 and platelets\\>= 75,000\u002Fmm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow\n* must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and\u002For hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry\n\nExclusion Criteria:\n\n* Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.\n* History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)\n* Subjects with Richter's transformation\n* Prior treatment with any gene therapy product\n* Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection\n* Systemic fungal, bacterial, viral, or other infection that is not controlled\n* Presence of acute or extensive chronic graft versus host disease (GVHD)\n* History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease\n* History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis\n* Pregnant or nursing (lactating) women\n* Use of any of the following medications or treatments within the noted time prior to leukapheresis:\n\n  1. Alemtuzumab within 6 months prior to leukapheresis\n  2. Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis\n  3. Cladribine within 3 months prior to leukapheresis\n  4. Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis\n  5. Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis\n  6. Fludarabine within 4 weeks prior to leukapheresis\n  7. GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α \\[TNFα\\], anti-interleukin-6 \\[IL-6\\], or anti-interleukin-6 receptor \\[IL 6R\\]) within 4 weeks prior to leukapheresis\n  8. Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis\n  9. Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days prior to leukapheresis\n  10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis\n  11. Venetoclax within 4 days prior to leukapheresis\n  12. Idelalisib or duvelisib within 2 days prior to leukapheresis\n  13. Lenalidomide or covalent and non-covalent BTKi within 1 day prior to leukapheresis\n  14. Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis\n* Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol\n* Progressive vascular tumor invasion, thrombosis, or embolism\n* Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation\n* Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.\n* Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation\n* For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate\u002Fstrong inducers or moderate\u002Fstrong inhibitors which cannot be discontinued","ALL","18 Years",{"count":19,"type":20},320,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.",[27,28],"Leukemia, Lymphocytic, Chronic, B-Cell","Lymphoma, Small Lymphocytic",[30],"TRANSCEND_CLL_004","RECRUITING","2026-03-02",{"date":34,"type":35},"2026-03-04","ACTUAL",{"date":37,"type":35},"2017-11-27",{"date":39,"type":20},"2027-11-26",{"name":41,"class":42},"Juno Therapeutics, a Subsidiary of Celgene","INDUSTRY",86,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":68,"locationsCount":4},"100393251","nonconforming-lisocabtagene-maraleucel-expanded-access-protocol-100393251","NCT04400591","Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol","Expanded Access Protocol (EAP) For Subjects Receiving Lisocabtagene Maraleucel That Is Nonconforming For Commercial Release","Inclusion Criteria:\n\n1. Subject and\u002For LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments\u002Fprocedures being conducted.\n2. Subject was prescribed lisocabtagene maraleucel (liso-cel) for a diagnosis that is approved per local prescribing information, per treating physician assessment.\n3. Subject is ≥ 18 years of age at the time of signing the informed consent form.\n4. Subject had a subject-specific batch of liso-cel manufactured intended for commercial treatment; however, the final manufactured product did not meet the local commercial release criteria.\n5. Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject.\n6. Subject is clinically stable, has recovered from any prior toxicities which places the subject at clinical risk prior to receiving LD chemotherapy, and has adequate bone marrow function to receive LD chemotherapy. The treating physician is advised to contact the Medical Monitor in the event there is any concern regarding administration of LD chemotherapy.\n7. Females of childbearing potential must:\n\n   1. Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact.\n   2. Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming liso-cel administration.\n   3. Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming liso-cel administration.\n   4. There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with liso-cel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.\n8. Male subjects must:\n\n   1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming liso-cel administration even if the subject has undergone a successful vasectomy.\n   2. There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with liso-cel. Any decision regarding contraception after infusion should be discussed with the treating physician\n9. Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming liso-cel administration.\n\nExclusion Criteria:\n\n1. Subject has a hypersensitivity to the active substance or to any of the excipients.\n2. Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming liso-cel.\n3. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement.\n4. Subject has any condition and\u002For laboratory abnormality that places the subject at unacceptable risk if he\u002Fshe were to participate in the Expanded Access Protocol based on the Investigator's judgement\n5. Pregnant or nursing women or has intention of becoming pregnant during the study.\n6. Subjects with primary central nervous system (CNS) lymphoma (note: subjects with secondary CNS involvement are allowed on study).\n7. Subject has uncontrolled hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation\n8. Subject has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming liso-cel administration.\n9. Subject has active acute or chronic graft-versus-host disease (ie, GVHD)\n10. Subject should not be actively receiving anticancer treatment that would, in the opinion of the treating physician, either increase the risk of AEs associated with LD chemotherapy or CAR T therapy or interfere with site routine care treatment plan associated with CAR T therapy. The treating physician is advised to consult with the Medical Monitor for case discussion if needed.","EXPANDED_ACCESS","This is an expanded access protocol that will be conducted at sites qualified and approved to treat subjects with lisocabtagene maraleucel. Sometimes when lisocabtagene maraleucel is manufactured the drug does not pass all the testing results to be called lisocabtagene maraleucel. When this happens the drug is called nonconforming lisocabtagene maraleucel. The expanded access protocol will be used to allow subjects to receive nonconforming lisocabtagene maraleucel only if the potential benefit is better than the potential risk. This expanded access protocol is restricted to those subjects who were prescribed lisocabtagene maraleucel as part of their routine care.\n\nSubjects will first receive a lymphodepleting chemotherapy regimen and then be treated with nonconforming lisocabtagene maraleucel as the treatment plan.",[54],"Lymphoma, Large B-Cell, Diffuse",[56,57,58,59,60,61,62,63],"Expanded Access","JCAR017","Lisocabtagene Maraleucel","CAR T","nonconforming;","relapsed\u002Frefractory diffuse large B cell lymphoma","nonconforming lisocabtagene mareleucel","liso-cel","AVAILABLE","2025-12-04",{"date":67,"type":35},"2025-12-11",{"name":41,"class":42},""]