[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Luminary Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":120},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,70,97],{"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":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645065","phase-1-baff-car-t-cells-lmy-922-for-treatment-of-refractory-hematologic-malignancies-100645065",false,"NCT07679919","BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","A Phase 1 Study of Allogeneic (γ\u002Fδ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","Inclusion Criteria:\n\n1\\. Male or female 18-75 years of age. 2. Patient with:\n\na. NHL: Histologically confirmed B cell NHL (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, MCL, marginal zone lymphoma (MZL)) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior chemotherapy (defined as progressive disease or stable disease lasting ≤ 6 months, as best response to most recent chemotherapy regimen; or disease progression, or recurrence ≤ 12 months after prior autologous stem cell transplantation (ASCT), and iii. Measurable disease per Lugano Revised Response Criteria for Malignant Lymphoma\n\nor\n\nb. CLL: histologically confirmed CLL i. Relapsed after 2 or more lines of therapy ii. Previous therapies prescribed must have included a Bruton's tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, iii. Measurable disease and active disease: Active disease as defined by the iwCLL criteria, meeting at least one of the following criteria:\n\n1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and\u002For thrombocytopenia. Cutoff levels of Hb \\\u003C10 g\u002FdL or platelet counts \\\u003C100 × 10\\^9\u002FL are generally regarded as indication for treatment.\n2. Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.\n3. Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.\n4. Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).\n5. Disease-related symptoms as defined by any of the following:\n\n   1. Unintentional weight loss ≥10% within the previous 6 months.\n   2. Significant fatigue (i.e., Eastern Cooperative Oncology Group (ECOG) performance scale 2 or worse; cannot work or unable to perform usual activities).\n   3. Fevers ≥ 38.0°C for 2 or more weeks without evidence of infection.\n   4. Night sweats for ≥1 month without evidence of infection.\n\nor\n\nc. HCL: histologically confirmed HCL i. Relapsed after at least one line of therapy, which must have included a purine nucleoside (eg. fludarabine, cladribine or pentostatin) and moxetumomab pasudotox.\n\nii. Need for treatment as evidenced by any one of the following: Absolute Neutrophil Count (ANC) \\\u003C1 × 10\\^3\u002FmcL, Hb \\\u003C10g\u002FdL, platelet count \\\u003C100 × 10\\^3\u002FmcL, leukemia cell count \\>5 × 10\\^3\u002FmcL, symptomatic splenomegaly, or enlarging HCL mass \\>2 cm in short axis.\n\nor\n\nd. MM: histologically confirmed MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.\n\nii. Measurable disease per IMWG uniform response criteria 3. Adequate organ function as defined by:\n\n1. Creatinine clearance more than or equal to 45 ml\u002Fmin calculated by the Cockcroft - Gault formula\n2. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.\n3. Adequate pulmonary function with pulse oximetry ≥ 92% on room air.\n4. Total Bilirubin \\\u003C 1.5× the institutional upper limit of normal (\\\u003C2.5× if caused by the baseline cancer and in patients with Gilbert's syndrome).\n5. Alanine aminotransferase (ALT (Serum Glutamic-Pyruvic Transaminase (SGPT))) and Aspartate Aminotransferase (AST (Serum Glutamic-Oxaloacetic Transaminase (SGOT) \\\u003C 2.5× the institutional upper limit of normal.\n\n   4\\. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n\n   5\\. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\nExamples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration\n\nof the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n6\\. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 1 year after CAR-T cell infusion to avoid potential embryonal or fetal exposure.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n7\\. Body weight of at least 55kg for patients treated at dose level 3 (450 × million BAFF+ CAR cells) and at least 37kg for all other dose levels.\n\nExclusion Criteria:\n\n1. Second active (i.e., currently requires antineoplastic therapy) non-B cell lineage malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).\n2. Renal failure requiring regular dialysis.\n3. Uncontrolled pulmonary disease or infection.\n4. Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n5. Active infection requiring systemic treatment.\n6. HIV seropositive with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months of enrollment, or has not been on an established antiretroviral therapy (ART) for at least four weeks with an HIV viral load less than 400 copies\u002FmL.\n7. Pregnant or breastfeeding women are excluded from this study (breastfeeding should be discontinued), because there is an unknown, but potential risk for adverse events in fetuses and nursing infants secondary to treatment of the mother with LMY-922 and lymphodepleting chemotherapy. Women of childbearing potential must have a negative serum pregnancy test.\n8. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n9. Patients with history of clinically relevant central nervous system (CNS) pathology such as uncontrolled epilepsy, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease.\n10. Subjects with uncontrolled intercurrent or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. Patients receiving a live vaccine within 2 weeks prior to screening.\n12. Concurrent use of high dose systemic steroids and\u002For immunosuppressive therapies.\n\n    1. Steroid dose must be weaned to ≤10 mg\u002Fday prednisone equivalent prior to CAR-T cell infusion.\n    2. Immunosuppressive medications must be stopped at least 5 half-lives prior to CAR-T cell infusion.","ALL","18 Years","75 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory hematologic malignancies, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.",[27,28,29,30],"Non-Hodgkin Lymphoma","Chronic Lymphocytic Leukemia","Hairy Cell Leukemia","Multiple Myeloma",[32,33],"Lymphoma","B-cell","NOT_YET_RECRUITING","2026-06-25",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":21},"2026-09",{"date":42,"type":21},"2029-04",{"name":44,"class":45},"Luminary Therapeutics","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100542275","phase-1-baff-car-t-cells-lmy-920-for-systemic-lupus-erythematosus-100542275","NCT06340750","BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus","A Phase I Study of BAFF CAR-T Cells (LMY-920) for Treatment of Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Age 18-69 years\n* Confirmed Systemic Lupus Erythematosus (SLE) as per Systemic Lupus International Collaborating Clinics (SLICC) 2012 Criteria with one or more of the following:\n\n  a. Active disease despite use of standard therapy (i) and one or more additional therapies (ii).\n\n  i. Corticosteroids (CS), Hydroxychloroquine ii. Mycophenolate mofetil (MMF), Methotrexate (MTX), Azathioprine (AZA), Tacrolimus (TAC), Cyclophosphamide (CYC), Rituximab, and\u002For belimumab b. Active disease due to intolerance of standard therapy (i) and one or more additional therapies (ii).\n\n  c. Steroid-Dependent Disease\n* Subjects must meet organ function criteria:\n\n  1. Creatinine clearance more than or equal to 30 ml\u002Fmin calculated by the Cockcroft - Gault formula\n  2. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 40% on the most recent echocardiogram.\n  3. Adequate pulmonary function with pulse oximetry ≥92% on room air\n  4. Total Bilirubin ≤ 1.5x the institutional upper limit of normal (except in patients with Gilbert's syndrome)\n  5. ALT (SGPT) and AST (SGOT) \\\u003C 3x the institutional upper limit of normal\n\nExclusion Criteria:\n\n* SLE complicated by:\n\n  * Active neuropsychiatric lupus\n  * Active secondary hemophagocytic lymphohistiocytosis (sHLH)\n* Presence of any medical or psychological conditions which may affect patient ability to comply with study protocol requirements and study visits\n* Presence of active, untreated infection such as:\n\n  * Active microbial infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic. Patients with active tuberculosis must have had at least 4 weeks of appropriate anti-mycobacterial treatment and be asymptomatic.\n  * Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n  * HIV positive test within 8 weeks of screening\n* Acute\u002Fongoing neurologic toxicity \\> Grade 1 except for a history of controlled seizures or fixed neurologic deficits that have been stable\u002Fimproving over the past 1 months.\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the CAR-T cell infusion.\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n* Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Men who will not agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:\n* With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the CAR-T cell infusion. Men must refrain from donating sperm during this same period.\n* With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the CAR- T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Patients receiving a live vaccines within the last two weeks.\n* A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.\n* Concurrent use of high dose systemic steroids and\u002For T cell directed immune suppression. Subjects must discontinue T cell targeted therapy \\>3 weeks and wean prednisone dose to ≤10 mg\u002Fday prior to leukapheresis.\n* Previous treatment with any gene or adoptive cell therapy products.\n* Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, serious arrhythmia, HIV, seizure disorder, cerebrovascular disease, psychiatric disease), that may interfere with the patient's ability to tolerate the therapy or comply with assessments.\n* Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Patients 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 (e.g. Low Gleason score prostate Cancer).","65 Years",{"count":56,"type":21},18,[24],"This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores.",[60],"Systemic Lupus Erythematosus","RECRUITING","2025-05-28",{"date":64,"type":38},"2025-06-03",{"date":66,"type":38},"2025-04-01",{"date":68,"type":21},"2026-06-15",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":46},"100481263","phase-1-lmy-920-for-treatment-of-relapsed-or-refractory-myeloma-100481263","NCT05546723","LMY-920 for Treatment of Relapsed or Refractory Myeloma","LUMT1A22, Phase 1 Study of BAFF CAR T Cells (LMY-920) for Treatment of Relapsed or Refractory Myeloma (LMY-920-002)","LMY-920-002","Inclusion Criteria:\n\n1. Subjects must have histologically confirmed myeloma relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Failing line of therapy is defined accordingly to International Myeloma Workshop Consensus Panel.\n2. No evidence of CNS myeloma.\n3. Male or female \\> 18 years of age.\n4. ECOG Performance status ≤ 2.\n5. Has measurable disease at the time of enrollment as defined by at least one of the following:\n\n   * Serum M-protein greater or equal to 0.5g\u002FdL\n   * Urine M-protein greater or equal to 200mg\u002F24hr\n   * Serum free light chain (FLC) assay: involved light chain greater or equal to 10mg\u002FdL provided serum FLC ratio is abnormal\n   * Bone marrow plasma cells greater than or equal to 30% total bone marrow cells\n6. \\>2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.\n7. Total bilirubin ≤ 1.5 mg\u002FdL (except in patients with Gilbert's syndrome).\n8. AST (SGOT)\u002FALT ≤ 2.5 X institutional upper limit of normal.\n9. Serum creatinine \\\u003C 2 mg\u002FdL.\n10. Cardiac ejection fraction of \\>45%, and no evidence of pericardial effusion, as determined by an echocardiogram.\n11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.\n12. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.\n14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n1. ASCT within 6 weeks of informed consent.\n2. History of allogeneic hematopoietic stem cell transplantation.\n3. Active graft-versus-host disease.\n4. Active central nervous system or meningeal involvement by myeloma. Subjects with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.\n5. Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).\n6. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.\n7. New York Heart Association class IV congestive heart failure.\n8. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n9. Active infection requiring intravenous systemic treatment.\n10. HIV seropositivity.\n11. Pregnant or breastfeeding women are excluded from this study because LMY-920 therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with LMY-920, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.\n12. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n13. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n14. Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n15. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n16. Known additional malignancies which require systemic treatment.\n17. History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.",{"count":79,"type":21},30,[24],"Since CAR-T cell treatment of refractory myeloma has shown success, based on preclinical data, we posit that CAR-T cells expressing B-cell activating factor (BAFF) can become another strategy to treat refractory myeloma, even after relapse following BCMA targeting CAR-T cell treatment. This will be phase 1 study of BAFF ligand CAR-T cells in relapsed and refractory myeloma.",[83,84],"Multiple Myeloma, Refractory","Multiple Myeloma in Relapse",[86,87,88],"multiple myeloma","CAR-T","BAFF ligand","2024-10-16",{"date":91,"type":38},"2024-10-18",{"date":93,"type":38},"2024-03-13",{"date":95,"type":21},"2025-10-31",{"name":44,"class":45},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100463292","phase-1-phase-1-study-of-baff-car-t-cells-lmy-920-for-non-hodgkin-lymphoma-100463292","NCT05312801","Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma","LMY-920 for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT).\n2. No evidence of central nervous system (CNS) lymphoma.\n3. Male or female \\> 18 years of age.\n4. Eastern Cooperative Oncology Group Performance status ≤ 2.\n5. At least one measurable lesion.\n6. \\>2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.\n7. Total bilirubin ≤ 1.5 mg\u002FdL (except in patients with Gilbert's syndrome).\n8. Aspartate aminotransferase\u002Falanine transferase ≤ 2.5 X institutional upper limit of normal.\n9. Serum creatinine \\\u003C 1.5 mg\u002FdL.\n10. Cardiac ejection fraction of \\>50%, and no evidence of pericardial effusion, as determined by an echocardiogram.\n11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.\n12. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.\n14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.\n\nExclusion Criteria:\n\n1. ASCT within 6 weeks of informed consent.\n2. History of allogeneic hematopoietic stem cell transplantation.\n3. Active graft-versus-host disease.\n4. Active central nervous system or meningeal involvement by lymphoma or leukemia.\n5. Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).\n6. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.\n7. New York Heart Association class IV congestive heart failure.\n8. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n9. Active infection requiring intravenous systemic treatment.\n10. HIV seropositivity.\n11. Pregnant or breastfeeding women.\n12. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n13. Serologic status reflecting active hepatitis B or C infection.\n14. Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n15. Subjects with uncontrolled intercurrent illness.\n16. Known additional malignancies which require systemic treatment.\n17. History of autoimmune disease with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.",{"count":105,"type":21},20,[24],"Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment.\n\nThis phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.",[109],"Lymphoma, Non-Hodgkin Lymphoma, B-Cell",[111],"non-Hodgkin lymphoma.",{"date":113,"type":38},"2024-10-21",{"date":115,"type":38},"2023-11-21",{"date":117,"type":21},"2025-09-02",{"name":44,"class":45},2,""]