[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-multiple-myeloma":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,46,72,92,117,140,171,193,221,246,274,296,317,342,364,388,422,444,466,486,511,533,550,567,589],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100614835","phase-2-a-study-to-evaluate-the-efficacy-of-cemsidomide--dexamethasone-in-participants-with-relapsedrefractory-multiple-myeloma-100614835",false,"NCT07284758","A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed\u002FRefractory Multiple Myeloma","A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed\u002FRefractory Multiple Myeloma","MOMENTUM","Inclusion Criteria:\n\n1. Be willing and able to provide signed informed consent for the study.\n2. Age ≥ 18 years at the time of signed consent.\n3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.\n4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1\u002F3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.\n5. Subjects need to have adequate organ function.\n6. Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.\n7. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.\n8. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.\n9. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.\n10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.\n\nExclusion Criteria:\n\n1. Presence of myeloma in the central nervous system (CNS).\n2. Subjects with any of the following:\n\n   * Systemic light chain amyloidosis\n   * Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome\n   * Myelodysplastic syndrome (MDS).\n3. Previously treated with cemsidomide.\n4. Clinically significant impaired cardiac function or cardiac disease.\n5. Thromboembolic event within 3 months prior to enrollment.\n6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years.\n7. Uncontrolled active bacterial, fungal, or viral infection.\n8. Inability or difficulty swallowing tablets.\n\nNOTE: Other inclusion\u002Fexclusion criteria may apply, per protocol.","ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed\u002Frefractory multiple myeloma (r\u002Fr MM).",[28,29],"Multiple Myeloma","Relapsed\u002FRefractory Multiple Myeloma",[31,32,28],"cemsidomide","dexamethasone","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2026-02-18",{"date":41,"type":22},"2030-03",{"name":43,"class":44},"C4 Therapeutics, Inc.","INDUSTRY",10,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100504584","phase-1-azd0120-in-relapsedrefractory-multiple-myeloma-durga-1-100504584","NCT05850234","AZD0120 in Relapsed\u002FRefractory Multiple Myeloma (DURGA-1)","A Phase Ib\u002FII Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed\u002FRefractory Multiple Myeloma (DURGA-1)","DURGA-1","Inclusion Criteria:\n\n* ≥18 years of age at the time of consent.\n* ECOG performance status of 0 or 1.\n* Documented diagnosis of MM per IMWG diagnostic criteria.\n* Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.\n* Have documented evidence of progressive disease per IMWG criteria.\n* Participant must have measurable disease at screening.\n* Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.\n\nExclusion Criteria :\n\n* Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.\n* Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply.\n* Participant has significant cardiac, neurological, or psychiatric conditions.\n* Any other significant medical conditions such as:\n\n  * Serious active or uncontrolled infection\n  * Active autoimmune disease or a history of autoimmune disease within 2 years\n  * Active plasma cell leukemia at the time of screening\n  * Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).\n* Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.\n\nOther protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":55,"type":22},182,[57,25],"PHASE1","This trial is a Phase 1b\u002F2, open-label, multicenter study of AZD0120, a CD19\u002FBCMA dual CAR T-cell therapy, in adult subjects with relapsed\u002Frefractory multiple myeloma.",[29],[61],"Multiple Myeloma, BCMA, CAR T, CD19, AZD0120","2026-06-19",{"date":64,"type":37},"2026-06-23",{"date":66,"type":37},"2023-07-20",{"date":68,"type":22},"2028-11-14",{"name":70,"class":44},"AstraZeneca",36,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100635917","phase-1-a-study-to-evaluate-ro7851624-in-participants-with-relapsedrefractory-multiple-myeloma-rrmm-100635917","NCT07558915","A Study to Evaluate RO7851624 in Participants With Relapsed\u002FRefractory Multiple Myeloma (RRMM)","An Open-Label, Multicenter, Phase Ia\u002Fb Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 12 weeks.\n* Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.\n* Measurable disease.\n\nExclusion Criteria:\n\n* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.\n* Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.\n* Prior allogeneic SCT.\n* Prior solid organ transplantation.",{"count":80,"type":22},160,[57],"This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors \\[PIs\\], immunomodulators \\[IMiDs\\], and anti-cluster of differentiation 38 \\[anti-CD38\\] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.",[29],"2026-06-18",{"date":64,"type":37},{"date":64,"type":22},{"date":88,"type":22},"2031-10-01",{"name":90,"class":44},"Genentech, Inc.",1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100567519","phase-1-a-study-to-assess-the-safety-and-anti-tumor-activity-of-regn7945-in-combination-with-linvoseltamab-in-adult-participants-with-relapsedrefractory-multiple-myeloma-100567519","NCT06669247","A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed\u002FRefractory Multiple Myeloma","A First-in-Human (FIH) Phase 1\u002F2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed\u002FRefractory Multiple Myeloma","COSTIMM","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 as described in the protocol\n2. Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD), and 1 proteasome inhibitor (PI) and have demonstrated disease progression on or after the last therapy, as defined in the protocol. Prior treatment with other BCMA directed immunotherapies, including BCMA CAR-T cells and BCMA antibody-drug conjugates (Phase 1 and 2), and with BCMA x CD3 bispecific antibodies (Phase 1 only), is allowed\n3. Participants must have the measurable disease for response assessment as described in the protocol\n4. Adequate hematologic, hepatic, and renal function as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n2. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter\n3. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment\n4. Treatment with systemic corticosteroid treatment with more than 10 mg per day of prednisone or steroid equivalent within 72 hours of start of study drug\n5. Participants who have known central nervous system (CNS) involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), history of a neurocognitive condition or CNS disorder, or history of seizure within 12 months prior to study enrollment\n6. Live or live attenuated vaccination within 28 days before first study drug administration with a vector that has replicative potential\n7. Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol\n8. Myelodysplastic syndrome or another malignancy in the past 3 years, except for nonmelanoma skin cancer, in situ carcinoma, thyroid cancer, or low-risk early stage prostate adenocarcinoma, as described in the protocol\n9. Significant cardiovascular disease as described in the protocol\n10. Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolled infection, such as CMV, as described in the protocol\n11. Known hypersensitivity to both allopurinol and rasburicase\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply",{"count":101,"type":22},186,[57,25],"This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a \"study drug\" or \"study drugs\" when combined).\n\nThis study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed.\n\nThe aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much\n* How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone\n* How much study drug(s) is in the blood at different times\n* Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects)\n* If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)",[29],[106],"R\u002FRMM","2026-06-17",{"date":109,"type":37},"2026-06-22",{"date":111,"type":37},"2024-12-11",{"date":113,"type":22},"2035-11-01",{"name":115,"class":44},"Regeneron Pharmaceuticals",8,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100451598","a-study-of-real-life-current-standards-of-care-in-participants-with-relapsed-andor-refractory-multiple-myeloma-100451598","NCT05160584","A Study of Real-Life Current Standards of Care in Participants With Relapsed and\u002For Refractory Multiple Myeloma","A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and\u002For Refractory Multiple Myeloma","MoMMent","Inclusion Criteria:\n\n* For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and\u002For refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date\n* For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2\n* For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period\n* For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection\n* For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy\n* For Period 1 and 2: Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible\n* For Period 1 and 2: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g\u002FdL or urine M-protein level 200 mg\u002F24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda free light chain ratio\n* Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)\n* Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)\n* For period 3: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\\>=) 0.5 grams per deciliter (g\u002FdL) or urine M-protein level \\>= 200 milligram (mg) \u002F24 hours; or b. serum immunoglobulin free light chain \\>= 10 milligrams per deciliter (mg\u002FdL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (\\>=1 lesion has 2 diameters \\>= 1 centimeter \\[cm\\])",{"count":126,"type":22},300,"OBSERVATIONAL","The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and\u002For refractory multiple myeloma.",[29],"2026-06-04",{"date":132,"type":37},"2026-06-05",{"date":134,"type":37},"2021-11-18",{"date":136,"type":22},"2028-07-31",{"name":138,"class":44},"Janssen Pharmaceutica N.V., Belgium",89,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":91},"100634569","phase-1-autologous-chimeric-antigen-receptor-car-t-cells-targeting-the-kappa-myeloma-antigen-kma-in-kappa-restricted-multiple-myeloma-patients-with-relapsedrefractory-disease-100634569","NCT07541391","Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed\u002FRefractory Disease","A Phase I Study of Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed\u002FRefractory Disease","KOALA","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the KOALA Patient Information and Consent Form (PICF)\n2. Age ≥ 18 years on the day of signing informed consent form\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 (Appendix 2)\n4. Life expectancy of ≥ 3 months, as assessed by the Investigator\n5. A diagnosis of kappa-restricted RR MM with evidence of KMA on the surface of bone marrow plasma cells using flow cytometry analysis as determined by investigator\n6. Have received at least 2 prior lines of therapy including a proteosome inhibitor and an immunomodulatory imide drug with evidence of disease progression as per IMWG criteria (Appendix 1) after the most recent line of therapy Note 1: induction with or without haematopoietic stem cell transplant (SCT), consolidation and maintenance therapy is considered a single line of therapy Note 2: Patients who have had prior treatment with a CAR T-cell therapy are eligible after a minimum of a 12 week washout between infusions.\n7. Have measurable disease as defined by: • Serum IgG, IgA, IgM M protein ≥ 0.5 g\u002FdL; or • Serum IgD M protein ≥ 0.05 g\u002FdL; or • An abnormal free light chain (FLC) assay (Freelite™) demonstrating an excess of kFLC with a kFLC component of at least 100 mg\u002FL and an abnormal k:λ FLC ratio Note: Patients who do not have measurable disease but who have demonstrable disease (i.e., oligo-secretory myeloma) based on evidence of bone lesions by at least 2 prior PET scan studies showing persistent disease may be included\n8. Last dose of nitrosourea, nitrogen mustards, or monoclonal antibody must have been at least 4 weeks prior to registration; autologous SCT must have been at least 12 weeks prior to registration; and allogeneic SCT must have been at least 24 weeks prior to registration. Limited field radiotherapy to painful lesions is allowed during Screening and bridging but must be completed 48 hours prior to planned apheresis and lymphodepleting chemotherapy\n9. Adequate haematological function documented within 7 days prior to registration, defined as: • Haemoglobin ≥ 80 g\u002FL (peripheral red blood cell transfusion support is allowed if marrow infiltrate is ≥ 50%) • Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL (GCSF support is allowed) , and ANC \\> 0.5 x 109\u002FL is allowed if neutropenia is due to disease infiltration of bone marrow) • Absolute lymphocyte count (ALC) ≥ 0.1 x 109\u002FL • Platelets ≥ 50 x 109\u002FL (platelet transfusion support is allowed for platelets ≥ 30 if due to disease infiltration by bone marrow, or splenomegaly due to disease involvement)\n10. Adequate cardiac function, defined as: • Left ventricular ejection fraction (LVEF) ≥ 40% on echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 90 days prior to registration• No suspicion for intercurrent deterioration in left ventricular function as assessed by the Investigator\n11. Adequate pulmonary function, defined as: • Oxygen saturation measured by pulse oximetry ≥ 90% on room air\n12. Adequate renal function documented within 7 days prior to registration, defined as any one of: • A serum creatinine ≤ 1.5 x upper limit of normal (ULN) • Creatinine clearance (CrCl) of ≥ 40 mL\u002Fmin calculated by Cockcroft-Gault formula (Appendix 3) • CrCl ≥ 40 mL\u002Fmin calculated by 24-hour urine collection post-ovulation methods) and withdrawal are not acceptable • Glomerular filtration rate (GFR) ≥ 40 mL\u002Fmin by renal scintigraphy\n13. Adequate hepatic function documented within 7 days prior to registration, defined as all of: • Total bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN in patients with Gilbert's syndrome or documented liver involvement) • Alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in patients with documented liver involvement) • Aspartate aminotransferase (AST) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in patients with documented liver involvement)\n14. Taking a maximum corticosteroid dose of 20 mg of oral prednisone or equivalent\n15. Females of childbearing potential (FCBP) and nonsterile male patients (with partners of childbearing potential) must agree to use highly effective methods of contraception from registration on the study to 2 months after the PMCC-COE-KMA infusion or until PMCC-COE-KMA CAR T-cells are no longer present by quantitative PCR on 2 consecutive tests whichever is later. Effective methods of contraception are: • Total abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptablemethods of contraception • Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks prior to registration. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by followup hormone level assessment • Male sterilisation (at least 6 months prior to Screening), noting that for female patients on the study, the vasectomised male partner should be the sole partner for that patient • Use of oral, (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months prior to registration • Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., ageappropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks prior to registration. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential\n16. Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test within 3 days prior to registration\n17. Sexually active male patients must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 52 weeks after the PMCC-COE-KMA infusion\n\nExclusion Criteria:\n\n1. A diagnosis of lambda-restricted MM\n2. Plasma cell leukaemia at the time of Screening (\\> 5% circulating plasma cells by standard differential), Waldenström's macroglobulinaemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis\n3. Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM\n4. Major surgery within 4 weeks prior to registration\n5. Receipt of a live, attenuated vaccine (except for COVID-19) within 4 weeks prior to the planned commencement of lymphodepleting conditioning\n6. Receipt of any investigational medical product within the last 30 days, or after 5 halflives (whichever is the shortest) prior to planned leukapheresis\n7. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months prior to Screening or class III to IV cardiac disease as defined by the New York Heart Association Functional Classification\n8. Clinically significant neurological disorders (e.g., uncontrolled seizure disorder, severe brain injury, dementia, Parkinson's disease, or autoimmune\u002Finflammatory disorders \\[e.g., Guillain-Barre syndrome, motor neuron disease, chronic inflammatory demyelinating polyneuropathy\\]) Note: Patients with a seizure disorder who have been seizure free and without modification to anti-epileptic therapy in the past 12 months are eligible\n9. History of other active malignancy, with the exception of: • Adequately treated in situ carcinoma of the cervix or breast • Adequately treated basal cell carcinoma of skin or localised squamous cell carcinoma of the skin • Low grade malignancies that are being observed and do not require treatment (e.g., low risk prostate cancer) • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and without evidence of recurrence for at least 2 years prior to registration\n10. Active human immunodeficiency virus (HIV) or hepatitis A, B, or C infection • Patients who are positive for HIV by enzyme-linked immunosorbent assay or Western Blot, are ineligible • Patients who are seropositive for hepatitis C virus (HCV) are eligible if their most recent HCV DNA assay is undetectable (including those that have received curative therapy) • Patients who are seropositive for hepatitis B virus (HBV) because of vaccination are eligible\n11. Other clinically significant active infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, viral DNA\u002FRNA by PCR)\n12. A known history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy (with the exception of corticosteroids up to 20 mg\u002Fday of oral prednisolone or equivalent)\n13. Current active graft-versus-host disease requiring immunosuppression (with the exception of corticosteroids up to 20 mg\u002Fday of oral prednisolone or equivalent)\n14. Other significant life-threatening illness, medical condition, or laboratory abnormality that, in the opinion of the Investigator, could compromise the patient's safety, impair their ability to receive PMCC-COE-KMA, or put the study outcomes at undue risk\n15. Known hypersensitivity to the excipients of PMCC-COE-KMA or to any product to be given to the patient as per the study protocol (e.g., tocilizumab and lymphodepleting agents)\n16. Women who are lactating\n17. Presence of any psychological, social, geographical, or other condition for which, in the opinion of the site Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":149,"type":22},12,[57],"The study proposed here intends to evaluate the safety and efficacy of escalating doses of autologous PMCC-COE-KMA CAR T-cells administered to patients with relapsed\u002Frefractory multiple myeloma that expresses the KMA. The PMCC-COE-KMA CAR T-cells will be produced using LV and administered to patients after lymphodepleting conditioning chemotherapy. Considering the poor prognosis of myeloma patients who have relapsed after ≥ 2 lines of therapy, combined with evidence of PMCC-COE-KMA CAR T-cell specificity, as well as the efficacy and manageable toxicity of PMCC-COE-KMA, investigators believe the potential benefits outweigh the risks of this trial.",[29],[154,155,156,157,28,29,158,159,160],"CART","Chimeric Antigen Receptor (CAR) T-cells","Kappa Myeloma Antigen","KMA","PMCC-COE-KMA","HaemalogiX","KMCAR","2026-05-22",{"date":163,"type":37},"2026-05-27",{"date":165,"type":22},"2026-05",{"date":167,"type":22},"2030-01",{"name":169,"class":170},"Peter MacCallum Cancer Centre, Australia","OTHER",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100437233","phase-1-a-phase-1b2-study-of-sonrotoclax-bgb-11417-as-monotherapy-and-in-various-combinations-with-dexamethasone-plus-carfilzomib-dexamethasone-plus-daratumumab-and-dexamethasone-plus-pomalidomide-in-multiple-myeloma-100437233","NCT04973605","A Phase 1b\u002F2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma","A Phase 1b\u002F2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone\u002FCarfilzomib, Dexamethasone\u002FDaratumumab, and Dexamethasone\u002FPomalidomide in Patients With Relapsed\u002FRefractory Multiple Myeloma and t(11;14)","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and\u002For urine)\n3. Measurable disease defined as:\n\n   i. M-spike ≥ 500mg\u002FdL, or ii. Urine protein M-spike of ≥ 200 mg\u002Fday, or iii. Serum free light chains ≥ 10 mg\u002FdL, and an abnormal κ:λ ratio\n4. Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.\n\n   i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.\n\n   ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.\n   1. In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.\n   2. Participants in Part 2 Cohorts 3, 4, and 5 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.\n   3. Participants in Part 2 Cohorts 6 and 7 should have relapsed or progressive disease and have had 1 to 3 prior lines of therapy and previously treated with a proteasome inhibitor and an IMiD\n5. Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory\n\n   a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.\n6. Adequate organ function defined as:\n\n   1. Hemoglobin ≥ 8.0 g\u002FdL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)\n   2. Platelet count ≥ 75,000\u002FμL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions\n   3. Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 within 7 days before first dose of study treatment\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be \\\u003C 3 x ULN for patients with Gilbert's syndrome)\n\nExclusion Criteria:\n\n1. Participant has any of the following conditions:\n\n   1. Non secretory MM (Serum free light chains \\\u003C 10 mg\u002FdL)\n   2. Solitary plasmacytoma\n   3. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or \\> 2.0 x 109\u002FL circulating plasma cells by standard differential)\n   4. Waldenström macroglobulinemia (WM)\n   5. Amyloidosis.\n   6. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome\n   7. Chronic respiratory disease that requires continuous oxygen\n2. Significant cardiovascular disease, including but not limited to:\n\n   1. Myocardial infarction ≤ 6 months before screening\n   2. Ejection fraction ≤ 50%\n   3. Unstable angina≤ 3 months before screening\n   4. New York Heart Association Class III or IV congestive heart failure\n   5. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n   6. Heart rate-corrected QT interval \\> 480 milliseconds based on Fridericia's formula\n   7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n   8. Uncontrolled hypertension at screening, defined as systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg by ≥ 2 consecutive measurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)\n3. Known infection with human immunodeficiency virus (HIV)\n4. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:\n\n   1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity \\\u003C 20 IU\u002FmL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.\n   2. Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity \\\u003C 15 IU\u002FmL).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":179,"type":22},246,[57,25],"The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed\u002Frefractory (R\u002FR) multiple myeloma (MM) and chromosomal translocation t(11;14).\n\nThe study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.",[29],"2026-05-08",{"date":185,"type":37},"2026-05-11",{"date":187,"type":37},"2021-09-16",{"date":189,"type":22},"2026-11",{"name":191,"class":44},"BeOne Medicines",84,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100505486","phase-1-study-of-isb-2001-in-relapsedrefractory-multiple-myeloma-trignite-1-100505486","NCT05862012","Study of ISB 2001 in Relapsed\u002FRefractory Multiple Myeloma (TRIgnite-1)","A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Participants with pathologically confirmed MM with measurable M-protein: serum and\u002For 24 hour urine, serum-free light chains or measurable isolated plasmacytoma\n2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less\n3. Must have adequate hematologic, hepatic, renal, and cardiac functions\n\nExclusion Criteria:\n\n1. Active malignant central nervous system involvement\n2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1\n3. History of autoimmune disease requiring systemic immunosuppressive therapy\n4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.\n5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.",{"count":201,"type":22},200,[57],"This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed\u002Frefractory multiple myeloma (R\u002FR MM).",[29],[206,207,208,209,210],"ISB 2001","Relapsed\u002Frefractory multiple myeloma","Open-label","Dose escalation","Dose expansion","2026-03-31",{"date":213,"type":37},"2026-04-01",{"date":215,"type":37},"2023-11-01",{"date":217,"type":22},"2027-07",{"name":219,"class":44},"Ichnos Sciences SA",32,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":91},"100632084","phase-2-il-15-armored-car-t-therapy-in-relapsed-or-refractory-multiple-myeloma-and-plasma-cell-leukemia-100632084","NCT07509086","IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia","A Clinical Study Evaluating the Safety and Efficacy of IL-15-armored Novel CAR-T Cell Therapy in Patients With Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Leukemia","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.\n2. Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status following induction and consolidation therapy are also eligible for enrollment.\n3. Age 18 to 80 years, inclusive.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n5. Estimated life expectancy \\> 3 months from the date of signing the informed consent form.\n6. Hemoglobin ≥ 60 g\u002FL (transfusion permitted).\n7. Adequate organ function as defined below:\n\n   * Creatinine clearance (CrCl) ≥ 40 mL\u002Fmin, calculated using the Cockcroft-Gault formula;\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * Oxygen saturation \\> 90% on room air;\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n8. Participants of childbearing potential must agree to use effective contraception prior to study enrollment and for at least 6 months after completion of study treatment. Participants who become pregnant or suspect pregnancy must notify the investigator immediately.\n\nExclusion Criteria:\n\n1. History within 1 year prior to signing the informed consent form of any of the following:\n\n   * New York Heart Association (NYHA) Class III or IV heart failure;\n   * Myocardial infarction;\n   * Cardiac angioplasty or stent placement;\n   * Unstable angina;\n   * Other clinically significant symptomatic cardiac disease;\n2. Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy.\n3. History of other malignancies within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after curative surgery.\n4. Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections).\n5. Evidence of active viral or infectious disease as follows:\n\n   * Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection;\n   * Positive hepatitis C virus (HCV) antibody with detectable HCV RNA;\n   * Positive human immunodeficiency virus (HIV) antibody;\n   * Positive Treponema pallidum particle agglutination assay (TPPA).\n6. Participation in another clinical trial within 4 weeks prior to signing the informed consent form, or if the time from the last dose of an investigational drug to informed consent is less than 5 half-lives of that drug (whichever is longer).\n7. History of severe allergic reactions to biologic products.\n8. Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment.\n9. Pregnant or breastfeeding women; women planning to become pregnant within 2 years after cell infusion; or male participants whose partners plan to become pregnant within 2 years after cell infusion.\n10. Any condition that, in the opinion of the investigator, may increase the participant's risk or interfere with study participation or interpretation of study results.","80 Years",{"count":7,"type":22},[25],"This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.",[29,233],"Plasma Cell Leukemia (PCL)",[29,235,236],"Plasma Cell Leukemia","IL-15-armored CAR-T","2026-03-28",{"date":239,"type":37},"2026-04-03",{"date":241,"type":37},"2025-12-29",{"date":243,"type":22},"2029-07-15",{"name":245,"class":170},"The First Hospital of Jilin University",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":273},"100632162","phase-1-eque-cel-for-the-treatment-of-patients-with-relapsedrefractory-multiple-myeloma-100632162","NCT07510100","Eque-cel for the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase I\u002FII Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) for the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","FUMANBA-04","* Inclusion Criteria\n* 1\\. Aged 18 to 70 years, male or female.\n* 2\\. Patients with a confirmed diagnosis of relapsed\u002Frefractory multiple myeloma according to the IMWG diagnostic criteria.\n* 3\\. Patients who have received at least three prior treatment regimens (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibody-based chemotherapy regimens) and have documented disease progression during or within 12 months of their most recent anti-myeloma treatment.\n* 4\\. Patients with measurable disease at screening, as determined by any of the following criteria:\n* Serum M-protein level: IgG type M-protein level ≥ 10 g\u002FL, IgA, IgD, IgE, IgM type M-protein level ≥ 5 g\u002FL\n* Urinary M-protein level ≥ 200 mg\u002F24 hours\n* 5\\. Light-chain multiple myeloma without measurable M protein in serum or urine: involved serum free light chain ≥ 100 mg\u002FL with an abnormal serum κ\u002Fλ free light chain ratio. ECOG PS 0 or 1.\n* 6\\. Patients must have adequate organ function and meet all of the following pre-enrollment laboratory test results:\n\nHematological Tests:\n\n* Absolute Neutrophil Count (ANC) ≥ 1×109\u002FL (Supportive growth factors are permitted, but supportive treatment must not have been administered within 7 days prior to the laboratory test)\n* Absolute Lymphocyte Count (ALC) ≥ 0.3×109\u002FL\n* Platelet Count ≥ 50×109\u002FL (Supportive transfusions must not have been administered within 7 days prior to the laboratory test)\n* Hemoglobin ≥ 60 g\u002FL (Red blood cell \\[RBC\\] transfusions must not have been administered within 7 days prior to the laboratory test, but recombinant human erythropoietin is permitted)\n\nLiver Function:\n\n* ALT and AST ≤ 2.5×upper limit of normal (ULN)\n* Serum Total Bilirubin ≤ 1.5 x ULN Renal Function: Creatinine clearance (CrCl) calculated using the Cockcroft-Gault formula ≥ 40 mL\u002Fmin CrCl = (140 - age) × weight (kg) × \\[0.85 for women\\] \u002F 72 × \\[ serum creatinine (mg\u002FdL)\\]\n\nCoagulation function:\n\n* Fibrinogen ≥ 1.0 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤ 1.5× ULN\n* Prothrombin time (PT) ≤ 1.5× ULN Corrected serum calcium ≤11 mg\u002FdL Oxygen saturation \\> 91% Left ventricular ejection fraction (LVEF) ≥ 50%.\n* 7\\. Female patients of childbearing potential or male patients with partners of childbearing potential agree to use effective contraception (safe-day contraception not included) throughout the study period from screening through one year after Eque-cel infusion.\n\n\"Effective contraceptive methods\" specifically refers to: User-independent methods: 1) Intrauterine devices, intrauterine hormone-releasing systems; 2) Partner has undergone vasectomy.\n\nUser-dependent methods: 1) Combined hormonal contraception (containing estrogen and progestin) with ovulation suppression:\n\nOral; 2) Progestin-only hormonal contraception with ovulation suppression ( oral).\n\n-8. Prior to screening, subjects must manually sign an Institutional Review Board-approved ICF.\n\nExclusion Criteria\n\n* 1\\. Patients with graft-versus-host disease (GVHD) or requiring long-term use of immunosuppressants.\n* 2\\. Patients with a history of BCMA-targeted therapy.\n* 3\\. Patients who have undergone autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks prior to apheresis, two auto-HSCTs, or prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* 4\\. Patients who have received prior anti-myeloma therapy, including:\n* Monoclonal antibody therapy within 21 days prior to apheresis.\n* Cytotoxic chemotherapy or proteasome inhibitor therapy within 14 days prior to apheresis.\n* Immunomodulatory therapy within 7 days prior to apheresis.\n* Other anti-myeloma therapy within 14 days or within 5 half-lives (whichever is longer) prior to apheresis.\n* 5\\. Use of systemic corticosteroids at a therapeutic dose (defined as \\>20 mg\u002Fday of prednisone or equivalent) within 7 days prior to apheresis.\n\nPhysiological replacement steroids, topical steroids, and inhaled steroids are permitted.\n\n* 6\\. Patients with uncontrolled hypertension despite medical therapy.\n* 7\\. Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] grade ≥ III), and severe arrhythmia.\n* 8\\. Unstable systemic disease as determined by the investigator, including but not limited to severe liver, renal, or metabolic disease requiring treatment.\n* 9\\. Patients with malignancies other than multiple myeloma (MM) within 5 years prior to screening.\n\nexcluding adequately treated cervical epithelial cell adenocarcinoma, basal cell carcinoma or squamous cell skin cancer, localized prostate cancer after curative surgery, and ductal carcinoma in situ after curative surgery.\n\n* 10\\. Patients with a history of solid organ transplantation.\n* 11\\. Patients with suspected or confirmed central nervous system infiltration by plasma cell neoplasms.\n* 12\\. Multiple myeloma patients with extramedullary lesions (excluding those with only paraskeletal extramedullary lesions where the single largest transverse diameter is ≤3cm).\n* 13\\. Multiple myeloma patients with concomitant plasma cell leukemia (peripheral blood plasma cell count ≥5%).\n* 14\\. Major surgery within 2 weeks prior to apheresis or planned surgery within 2 weeks after study treatment (subjects scheduled for local anesthesia surgery may participate in this study).\n* 15\\. Received investigational drugs from other interventional clinical trials within 1 month prior to signing the Informed Consent Form (ICF).\n* 16\\. Patients with an uncontrolled active infection (excluding CTCAE Grade 2 urinary tract infection or respiratory infection) within 7 days prior to apheresis.\n* 17\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with detectable hepatitis B virus (HBV) DNA in peripheral blood; Hepatitis C virus (HCV) positive with hepatitis C virus (HCV) RNA positive in peripheral blood; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; Syphilis test positive.\n* 18\\. Pregnant or lactating women.\n* 19\\. Patients with psychiatric disorders, impaired consciousness, or central nervous system disease.\n* 20\\. Patients whose non-hematologic toxicities from previous antimyeloma therapy have not resolved to baseline or Grade ≤ 1 (NCI-CTCAE v5.0) (excluding alopecia and Grade 2 peripheral neuropathy).\n* 21\\. Other conditions deemed ineligible for enrollment by the investigator.","70 Years",{"count":256,"type":22},17,[57,25],"This study is a single-armed, open-label, multicenter Phase 1\u002F2 study to evaluate the efficacy and safety of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) in subjects with relapsed and refractory Multiple Myeloma.",[29],[261,28,262,263],"Relapsed\u002FRefractory","BCMA","CAR-T","NOT_YET_RECRUITING","2026-03-27",{"date":239,"type":37},{"date":268,"type":22},"2026-05-10",{"date":270,"type":22},"2030-01-31",{"name":272,"class":44},"Nanjing IASO Biotechnology Co., Ltd.",3,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":228,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100630858","early-phase-1-a-study-of-imv102-in-patients-with-relapsedrefractory-multiple-myeloma-100630858","NCT07493135","A Study of IMV102 in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age: Aged 18 to 80 years (inclusive), of either sex.\n2. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n3. Diagnosed with relapsed\u002Frefractory multiple myeloma according to the IMWG criteria, who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent-based regimen).\n4. Reproductive Status: Subjects of childbearing potential and their partners must agree to use medically accepted highly effective contraceptive methods (e.g., intrauterine device, condom) from the time of signing the informed consent form until 12 months after the last dose. They must not donate germ cells, including sperm or oocytes, during this period.\n5. Informed Consent: Subjects must voluntarily sign and date a written informed consent form (ICF) indicating agreement to participate in this study.\n6. Compliance: Subjects must be willing and able to comply with the scheduled treatment plan, laboratory tests, follow-up, and other study requirements.\n\nExclusion Criteria:\n\n1. Pregnancy\u002FLactation: Women who are pregnant or breastfeeding.\n2. Other Malignancies: Subjects with a prior or concurrent other malignancy.\n3. Infectious Diseases: Positive for human immunodeficiency virus (HIV) antibody; active hepatitis B virus infection (HBV-DNA \\> 10³ IU\u002FmL); acute or chronic active hepatitis C (HCV antibody positive); positive syphilis antibody; cytomegalovirus (CMV) infection (IgM positive or DNA positive).\n4. Presence of clinically active uncontrolled infection based on assessment done by treating physicians.\n5. Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment.\n6. Allergies: History of other severe allergies such as anaphylactic shock; known severe allergic reaction to IMV102 or any of its components; known severe allergic reaction to tocilizumab.\n7. Psychiatric Disorders: Subjects with severe mental disorders.\n8. Transplant History: History of solid organ transplantation.\n9. Compliance: Subjects whom the investigator assesses as unable or unwilling to comply with the requirements of the study protocol.\n10. Other Conditions: Subjects with any other concurrent severe and\u002For uncontrolled medical conditions that, in the judgment of the investigator, make them unsuitable for participation in this study.",{"count":282,"type":22},30,[284],"EARLY_PHASE1","This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed\u002Frefractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.\n\nTumor response will be evaluated according to the International Myeloma Working Group (IMWG) uniform response criteria (2016). Assessments will be performed at baseline, and then at Day 28 post-infusion, Month 2, Month 3, and subsequently every 3 months from Month 3 to Month 24, until the subject completes the 24-month follow-up period, experiences disease progression (PD)\u002Frelapse, initiates new anti-tumor therapy, dies, or withdraws from the study, whichever occurs first.",[29],"2026-03-25",{"date":289,"type":37},"2026-03-30",{"date":211,"type":22},{"date":292,"type":22},"2028-04-01",{"name":294,"class":44},"Suzhou Immunofoco Biotechnology Co., Ltd",4,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":228,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":295},"100627865","phase-1-to-evaluate-the-safety-of-sg2918-in-patients-with-relapsedrefractory-multiple-myeloma-100627865","NCT07454187","To Evaluate the Safety of SG2918 in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase 1b\u002F2 Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 for Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 80 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n3. Life expectancy ≥ 3 months.\n4. Documented diagnosis of multiple myeloma.\n5. Measurable disease at screening (per IMWG criteria).\n6. Relevant laboratory values obtained within 7 days prior to the first dose must meet protocol-specified thresholds.\n7. Resolution of adverse events related to prior antineoplastic therapy to Grade ≤ 1 or baseline (CTCAE v6.0).\n8. Female participants of childbearing potential and male participants whose partners are of childbearing potential must use at least one acceptable method of contraception during study treatment and for at least 7 months after the last dose.\n9. Male participants must refrain from sperm donation from the signing of the Informed Consent Form (ICF) until at least 7 months after the last study dose.\n\nExclusion Criteria:\n\n1. Patients with primary refractory multiple myeloma.\n2. Presence of non-bone-related extramedullary soft tissue plasmacytoma at screening.\n3. known meningeal or Central Nervous System involvement of multiple myeloma, or high suspicion of unconfirmed meningeal or Central Nervous System involvement.\n4. History of peripheral neuropathy of Grade ≥ 2.\n5. Active infection requiring systemic therapy within 2 weeks prior to the first dose.\n6. Hypertension that was not effectively controlled by standardized antihypertensive treatment within 2 weeks prior to the first dose, as judged by the investigator\n7. History of hypertensive crisis or hypertensive encephalopathy.\n8. Poorly controlled diabetes mellitus.\n9. Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose.\n10. Active hepatitis B or hepatitis C infection.\n11. Known history of active tuberculosis or active syphilis.\n12. Known hypersensitivity to any component of the investigational product.\n13. history of Grade 3-4 allergic reaction or life threatening hypersensitivity to any biological product.\n14. Received any of the following therapies or surgeries.\n\n    1. Prior treatment with LILRB4 targeted therapy; or severe adverse reaction to prior MMAE containing therapy.\n    2. Immunotherapy, macromolecular targeted therapy, or other antineoplastic biologic therapy within 28 days prior to the first dose.\n    3. Cytotoxic chemotherapy or small molecule therapy within 14 days prior to the first dose.\n    4. Modernized traditional Chinese herbal medicine with approved antineoplastic indications within 7 days prior to the first dose.\n15. Requirement for systemic corticosteroids (equivalent to \\> 10 mg prednisone per day) or other immunosuppressive agents within 14 days prior to the first dose or during the study.\n16. Administration of any live or live attenuated vaccine within 28 days prior to the first dose.\n17. Administration of other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose.\n18. Immune related toxicity during prior antineoplastic immunotherapy that resulted in permanent treatment discontinuation.\n19. Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia;\n20. Current acute pulmonary disease, interstitial lung disease, or pneumonia.\n21. Any other malignancy diagnosed within 5 years prior to the first dose.\n22. Documented history of neurological or psychiatric disorder.\n23. Any other condition that, in the opinion of the investigator, may render the participant unsuitable for study participation.",{"count":304,"type":22},40,[57,25],"The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed\u002Frefractory multiple myeloma.",[29],"2026-03-03",{"date":310,"type":37},"2026-03-06",{"date":312,"type":22},"2026-03-14",{"date":314,"type":22},"2028-12-31",{"name":316,"class":44},"Hangzhou Sumgen Biotech Co., Ltd.",{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100506423","phase-2-a-collaborative-community-effort-using-belantamab-mafodotin-in-relapsedrefractory-myeloma-100506423","NCT05874193","A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed\u002FRefractory Myeloma","COSTA","Inclusion Criteria:\n\n* 1\\. Participant must have histologically or cytologically confirmed diagnosis of MM as defined by IMWG, 2016 criteria, have had at least 4 prior therapies, and is relapsed or refractory to an anti-CD38 antibody, an IMID, and a proteasome inhibitor.\n\n  1. Refractory myeloma is defined as disease that is nonresponsive while on therapy or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve at least minimal response or development of progressive disease (PD) while on any therapy.\n\n     2\\. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Participant must be ≥ 18 years of age 4. Participant must have adequate organ function, defined as follows: 5. Female participants:\n\n  a. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: i. Is not a woman of childbearing potential (WOCBP) OR ii. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency (as described in Appendix 3), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n\nA WOCBP must have a negative highly sensitive serum\u002Furine pregnancy test (as required by the protocol) within 72 hours before the first dose of study intervention. WOCBP will have pregnancy testing within 72 hours on day 1 of each cycle.\n\nThe investigator is responsible for review of medical history, menstrual history, and recent sexual activity.\n\nb. Nonchildbearing potential is defined as follows: i. Premenarchal ii. Premenopausal female with ONE of the following:\n\n1\\. Documented hysterectomy 2. Documented bilateral salpingectomy 3. Documented bilateral oophorectomy 4. Documented post-tubal ligation surgery 5. For individuals with permanent infertility due to an alternate medical cause other than the above, (e.g., mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry.\n\na. Note: Documentation can come from the site personnel's: review of participant's medical records, medical examination, or medical history review iii. Postmenopausal female\n\n1. A postmenopausal state is define as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.\n2. Females on HRT and whose menopausal status is in doubt will be required to use of the non-estrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n\n6\\. Male participants:\n\nMale participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:\n\n1. Refrain from donating sperm PLUS, either\n2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n\nOR c. Must agree to use contraception\u002Fbarrier as detailed below: i. Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n\n7\\. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be ≤ Grade 1 at the time of enrollment except for alopecia or at a stable baseline for at least 6 weeks.\n\n8\\. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent 9. Participant must agree to not wear contact lenses while on the study 10. Participant must agree to have a detailed eye exam by an eye care specialist prior to each treatment of Belantamab mafodotin and agree to use preservative-free lubricant eye drops at least 4 times every day while on treatment\n\nExclusion Criteria:\n\n* 1\\. Participant must not have current corneal epithelial disease except mild changes in corneal epithelium 2. Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria 3. Participant must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria 4. Participant unwilling to forego use of contact lenses while participating in this study 5. Participant must not be simultaneously in any other therapeutic clinical trial without permission of the Sponsor 6. Participant must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug and to have recovered from any drug-related drug toxicity to at least Grade 1 7. Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment 8. Participant must not have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs 9. Participant must not have had major surgery ≤ 4 weeks prior to initiating study treatment 10. Participant must not have any evidence of spontaneous mucosal or internal bleeding 11. Participant must not have had prior allogenic stem cell transplant. NOTE: Participants who have undergone syngeneic transplant will be allowed only if no currently active GvHD.\n\n  12\\. Participant must not have evidence of significant cardiovascular risk including any of the following:\n\n  a. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.\n\n  b. History of recent myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of initiating therapy on this study.\n\n  c. Class III or IV heart failure as defined by the New York Heart Association functional classification system \\[NYHA, 1994\\] d. Uncontrolled hypertension 13. Participant must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or dexamethasone, or any components of the study drug.\n\n  14\\. Participant must not have an active infection requiring treatment 15. Known HIV infection, unless the participant can meet all of the following criteria:\n  1. Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \\\u003C400 copies\u002FmL\n  2. CD4+ T-cell (CD4+) counts ≥350 cells\u002FuL\n  3. No history of AIDS-defining opportunistic infections within the last 12 months NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug: drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant (See section 4.3, Concomitant Therapy) 16. Participant must not have presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.\n\n     17\\. Participant must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.\n\n     NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, if a confirmatory negative Hepatitis C RNA test is obtained.\n\n     NOTE: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.\n\n     18\\. Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer, prostate cancer or ductal carcinoma in-situ breast cancer not requiring ongoing therapy may be enrolled without a 2-year restriction.\n\n     19\\. Participant must not have any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures",{"count":325,"type":22},33,[25],"This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed\u002Frefractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and\u002For reduced efficacy.",[29],[330,331,332],"relapsed\u002Frefractory Multiple Myeloma","Belantamab Mafodotin","Blenrep","2026-02-03",{"date":335,"type":37},"2026-02-05",{"date":165,"type":22},{"date":338,"type":22},"2028-06",{"name":340,"class":170},"Cristiana Costa Chase, DO",5,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":363},"100519879","phase-1-a-phase-iii-clinical-trial-of-lbl-034-in-patients-with-relapsed-refractory-multiple-myeloma-100519879","NCT06049290","A Phase I\u002FII Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma","A Multicenter, Open-label, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-034 in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form;\n2. Age ≥ 18 years at the time of signing the informed consent;\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale≤ 1；\n4. Documentation of initial diagnosis of multiple myeloma according to IMWG diagnostic criteria；\n5. Have a life expectancy of at least 12 weeks；\n6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.\n\nExclusion Criteria:\n\n1. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug,or require elective surgery during the trial period;\n2. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin-2, and interferon；\n3. Systemic use of corticosteroids or other immunosuppressants within 14 days prior to the initial use of the investigational drug;The following conditions are excluded: Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., to prevent contrast allergy);\n4. Patients with active hepatitis B or C；\n5. Subjects with an active infection that currently requires intravenous anti infective therapy;\n6. The patient has a Medical history of immunodeficiency, including HIV antibody positive;\n7. Women during pregnancy or lactation;\n8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.",{"count":350,"type":22},342,[57,25],"This is a single-arm, open-label, multicenter, dose-escalation, and dose-expansion phase I\u002FII clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and efficacy of LBL-034 in patients with Relapsed\u002FRefractory Multiple Myeloma (R\u002FR MM).",[29],"2025-12-03",{"date":356,"type":37},"2025-12-04",{"date":358,"type":37},"2023-10-20",{"date":360,"type":22},"2027-05-20",{"name":362,"class":44},"Nanjing Leads Biolabs Co.,Ltd",26,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":374,"conditions":375,"keywords":377,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":91},"100572206","early-phase-1-a-study-of-ct0596-in-relapsedrefractory-multiple-myeloma-and-relapsed-refractory-plasma-cell-leukemia-100572206","NCT06730256","A Study of CT0596 in Relapsed\u002FRefractory Multiple Myeloma and Relapsed\u002F Refractory Plasma Cell Leukemia","A Clinical Study to Explore the Safety, Efficacy, and Pharmacokinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma and Relapsed\u002FRefractory Plasma Cell Leukemia","Inclusion Criteria:\n\n* Participants must meet all of the following criteria to be enrolled:\n\n  1. Patients must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the trial visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.\n  2. Age ≥ 18 years;\n  3. Patients with R\u002FRMM who have received at least 3 prior lines of therapy, including at least 1 proteasome inhibitor and at least 1 immunomodulator (IMiD). Patients with RRpPCL had received at least 1 prior line of therapy. Number of lines of therapy was defined according to the guidelines provided in Rajkuma\\[1\\]r 2015 . Patients must have received at least 1 complete cycle of therapy for each line of therapy.\n  4. According to multiple myeloma IMWG 2016 and plasma cell leukemia IMWG 2013, patients must have progressive disease following or during the last treatment.\n  5. Patients must have measurable disease based on at least one of the following parameters:\n  6. Expected survival \\> 12 weeks;\n  7. Eastern Cooperative Oncology Group (ECOG) score 0- 1 ;\n  8. Patients should meet the following test results\n  9. Female patients of childbearing potential must have a negative pregnancy test at screening and prior to receiving lymphodepletion therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study ;Male patients are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited within 1 year following study treatment infusion for all male patients during the study.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or lactating women; 2. Patient has any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the patient to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments 3. Patients seropositive for HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and or nucleic acid testing; 4. Patients with any uncontrolled active infection, including but not limited to patients with active tuberculosis (investigator 's judgment); 5. Toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator; 6. Previous allogeneic stem cell transplantation; autologous stem cell transplantation within 12 weeks prior to signing informed consent; 7. Have received treatment for the disease within 14 days before informed consent 8. Have received cell therapy within 28 days before informed consent. 9. Systemic glucocorticoids equivalent to \\> 15 mg\u002Fday prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids; 10. Vaccination with live attenuated vaccines , inactivated vaccines or RNA vaccines within 4 weeks prior to informed consent; 11. Allergic or intolerant to lymphodepletion, tocilizumab, or allergic to components (DMSO) in CT0596 CART cell infusion preparation; or previous history of other serious allergies such as anaphylactic shock; 12. Patients with secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at Screening; 13. Patients with any of the following cardiac conditions within 6 months prior to screening: 14. Patients who require supplemental oxygen to maintain oxygen saturation \\> 92%; or Patients with known or suspected COPD who have Forced Expiratory Volume in 1 second (FEV1) \\\u003C 50% of predicted normal on spirometry; 15. Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive therapy; 16. Patients with second primary malignancies in addition to MM are not eligible if the second primary malignancy has required treatment within the past 2 years or is not in complete remission. Exceptions include the following that have been successfully treated - nonmetastatic basal cell or squamous cell skin carcinoma, non-metastatic prostate cancer, carcinoma-in-situ of breast or cervix, non-muscle invasive bladder cancer 17. Patients with symptomatic central nervous system (CNS) disease or suspected CNS metastases; 18. Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract)",{"count":372,"type":22},24,[284],"A Clinical Study to Explore the Safety, Efficacy, and Cellular Metabolic Dynamics of CT0596 CAR-T Cell Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Leukemia.",[376,29],"Relapsed\u002FRefractory Plasma Cell Leukemia",[29,378,263],"Relapsed or Refractory Plasma Cell Leukemia","2025-09-26",{"date":381,"type":37},"2025-10-01",{"date":383,"type":37},"2025-07-23",{"date":385,"type":22},"2027-12-31",{"name":387,"class":170},"The First Affiliated Hospital of Soochow University",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100494764","phase-1-crispr-edited-allogeneic-anti-bcma-car-t-cell-therapy-in-patients-with-relapsedrefractory-multiple-myeloma-100494764","NCT05722418","CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed\u002FRefractory Multiple Myeloma (CaMMouflage Trial)","CaMMouflage","Inclusion Criteria:\n\n1. Documented diagnosis of relapsed\u002Frefractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)\n2. Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.\n3. Eastern Cooperative Oncology Group performance status grade of 0 or 1.\n4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.\n\nExclusion Criteria:\n\n1. Prior treatment with CAR-T cell therapy directed at any target.\n2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion.\n3. Allogeneic stem cell transplant within 6 months before lymphodepletion.\n4. Known active or prior history of CNS involvement.\n5. Stroke or seizure within 6 months of signing ICF.\n6. Seropositive for or history of human immunodeficiency virus.\n7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.\n8. Hepatitis B infection.\n9. Hepatitis C infection.\n10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.",{"count":397,"type":22},50,[57],"This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).",[29],[394,402,28,403,404,262,405,406,407,408,409,263,410,411],"Allogeneic","Relapse Refractory Multiple Myeloma","CAR-T Cells","Cell Therapy","Cellular Immuno-therapy","CB11A","CB-011","CB-011A","Anti BCMA","ALLO CAR T","2025-09-23",{"date":414,"type":37},"2025-09-25",{"date":416,"type":37},"2023-02-06",{"date":418,"type":22},"2027-12",{"name":420,"class":44},"Caribou Biosciences, Inc.",16,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":149},"100555199","phase-3-a-clinical-study-comparing-sg301-plus-pomalidomide-and-dexamethasone-to-placebo-plus-pomalidomide-and-dexamethasone-in-relapsed-or-refractory-multiple-myeloma-patients-100555199","NCT06508983","A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients","A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form (ICF).\n2. Males and females aged 18-75 years (inclusive)\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2\n4. Expected survival time of ≥3 months.\n5. Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.\n6. Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.\n7. Subjects must have documented evidence of PD on or after the last regimen.\n8. Adequate function of vital organs\n9. Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment.\n\nExclusion Criteria:\n\n1. Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.\n2. Bone independent extramedullary disease at screening.\n3. Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.\n4. Previous exposure to pomalidomide.\n5. Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;\n6. Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;\n7. Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment;\n8. Active hepatitis B, or C.\n9. Known HIV infection.\n10. Known active tuberculosis or positive treponema pallidum antibodies.\n11. Subjects with clinical significant organ dysfunction that does not meet the study needs.\n12. Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.\n13. Known allergy to any component of the investigational medicinal product.\n14. Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.","75 Years",{"count":431,"type":22},360,[433],"PHASE3","The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.",[29],"2025-06-24",{"date":438,"type":37},"2025-06-27",{"date":440,"type":37},"2024-06-14",{"date":442,"type":22},"2028-03-31",{"name":316,"class":44},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":464,"locationsCount":91},"100456141","phase-1-a-study-of-car-gprc5d-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100456141","NCT05219721","A Study of CAR-GPRC5D in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:\n\n* Subjects must satisfy all the following criteria to be enrolled in the study:\n\n  1. age 18 to 75 years old, male or female.\n  2. Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).\n\n     According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;\n  3. Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).\n  4. The subjects should have measurable disease based on at least one of the following parameters:\n\n     The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.\n\n     Serum M-protein ≥ 0.5 g\u002FdL. Urine M-protein ≥ 200 mg\u002F24 hrs. For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg\u002FdL (100 mg\u002FL) provided serum FLC ratio is abnormal.\n\n     In subjects with extramedullary myeloma, if there are no other evaluable lesions, require extramedullary lesions with a maximum diameter of ≥2cm\n  5. ECOG performance score 0-2.\n  6. Estimated life expectancy ≥ 12 weeks.\n  7. Subjects should have adequate organ function:\n\n     * Hematology: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL; platelets ≥40×10\\^9 \u002FL (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g\u002FL (subjects must not have received transfusion of red blood cells \\[RBC\\] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).\n     * Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n     * Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml\u002Fmin.\n     * Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.\n     * SpO2 \\> 91%.\n     * Left ventricular ejection fraction (LVEF) ≥ 50%.\n  8. The subject and his\u002Fher spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.\n  9. Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.\n\n     Exclusion Criteria:\n* The presence of any of the following will exclude a subject from enrollment:\n\n  1. Subjects who are known to have GVHD or need long-term immunosuppressive therapy.\n  2. Subjects have received any anti-cancer treatment as follows:\n\n     monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.\n  3. Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \\> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.\n  4. Subjects with hypertension that cannot be controlled by medication.\n  5. Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.\n  6. Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.\n  7. Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.\n  8. Subjects with a history of organ transplantation.\n  9. Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).\n  10. Subjects participated in another interventional clinical study 1 months before signing the informed consent (ICF);\n  11. Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).\n  12. Positive for any of the following tests:\n\n      * Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood\n      * Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood\n      * Human immunodeficiency virus (HIV) antibody\n      * Cytomegalovirus (CMV) DNA\n      * Treponema Pallidum antibody\n  13. Pregnant or lactating women.\n  14. Subjects with mental illness or consciousness disorder or disease of the central nervous system\n  15. Other conditions that researchers consider inappropriate for inclusion.",{"count":452,"type":22},18,[57],"This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R\u002FR MM or plasma cell leukemia.",[29,235],[263,457],"GPRC5D","2025-06-06",{"date":460,"type":37},"2025-06-11",{"date":462,"type":37},"2022-03-17",{"date":381,"type":22},{"name":465,"class":170},"Chunrui Li",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":91},"100497634","phase-1-a-study-of-car-gprc5d-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100497634","NCT05759793","Inclusion Criteria:\n\nSubjects must satisfy all the following criteria to be enrolled in the study:\n\n1. age 18 to 75 years old, male or female.\n2. Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).\n\n   According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;\n3. Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).\n4. The subjects should have measurable disease based on at least one of the following parameters:\n\n   1. The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.\n   2. Serum M-protein ≥ 10 g\u002FL for IgG type, serum M-protein ≥ 5 g\u002FL for other types, such as IgA, IgD, IgM, IgE.\n   3. Urine M-protein ≥ 200 mg\u002F24 hrs.\n   4. For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg\u002FdL (100 mg\u002FL) provided serum FLC ratio is abnormal.\n   5. In subjects with extramedullary myeloma, if there are no other evaluable lesions, require extramedullary lesions with a maximum diameter of ≥2cm\n5. ECOG performance score 0-2.\n6. Estimated life expectancy ≥ 12 weeks.\n7. Subjects should have adequate organ function:\n\n   1. Hematology: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL; platelets ≥40×10\\^9 \u002FL (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g\u002FL (subjects must not have received transfusion of red blood cells \\[RBC\\] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).\n   2. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n   3. Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml\u002Fmin.\n   4. Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.\n   5. SpO2 \\> 91%.\n   6. Left ventricular ejection fraction (LVEF) ≥ 50%.\n8. The subject and his\u002Fher spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.\n9. Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a subject from enrollment:\n\n1. Subjects who are known to have GVHD or need long-term immunosuppressive therapy.\n2. Subjects have received any anti-cancer treatment as follows:\n\n   monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.\n3. Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \\> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.\n4. Subjects with hypertension that cannot be controlled by medication.\n5. Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.\n6. Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.\n7. Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.\n8. Subjects with a history of organ transplantation.\n9. Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).\n10. Subjects participated in another interventional clinical study 1 months before signing the informed consent (ICF);\n11. Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).\n12. Positive for any of the following tests:\n\n    Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody; Cytomegalovirus (CMV) DNA; Treponema Pallidum antibody\n13. Pregnant or lactating women.\n14. Subjects with mental illness or consciousness disorder or disease of the central nervous system\n15. Other conditions that researchers consider inappropriate for inclusion.",{"count":149,"type":22},[57],"This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R\u002FR MM or Plasma Cell Leukemia.",[29,235],[457,476,477],"RRMM","PCL","2025-05-15",{"date":480,"type":37},"2025-05-20",{"date":482,"type":37},"2023-03-30",{"date":484,"type":22},"2026-10-01",{"name":272,"class":44},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":4},"100584393","lcar-m61sq-in-treatment-of-relapsedrefractory-multiple-myeloma-100584393","NCT06888752","LCAR-M61SQ in Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61SQ Cell in Patients with Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\n* Subjects voluntarily participate in clinical research;\n* Age ≥18 years old;\n* Eastern Cooperative Oncology Group (ECOG) score 0-2;\n* Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;\n* Measurable lesions were present;\n* Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);\n* Expected survival ≥3 months;\n* Clinical laboratory values in the screening period meet criteria;\n\nExclusion Criteria:\n\n* Received previous therapy targeting GPRC5D targets;\n* Prior antineoplastic therapy and meet exclusion criteria (before apheresis);\n* Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.\n* Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;\n* Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.\n* Serious underlying diseases were present;\n* Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.\n* Also enrolled in other clinical studies.",{"count":494,"type":22},35,[496],"NA","A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed\u002Frefractory multiple myeloma.",[29],[500,501],"multiple myeloma","Relapsed\u002FRefractory multiple myeloma","2025-03-17",{"date":504,"type":37},"2025-03-21",{"date":506,"type":22},"2025-03-20",{"date":508,"type":22},"2030-12-30",{"name":510,"class":170},"First Affiliated Hospital of Wenzhou Medical University",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":532},"100567484","phase-2-an-open-label-clinical-study-of-the-efficacy-and-safety-of-bcd-248-in-patients-with-relapsedrefractory-multiple-myeloma-100567484","NCT06668792","An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed\u002FRefractory Multiple Myeloma","An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects With Relapsed\u002FRefractory Multiple Myeloma","FLAMMINGO","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age ≥18 years.\n3. Documented diagnosis of multiple myeloma according to the IMWG criteria.\n4. Measurable disease at screening.\n5. Subjects who received at least 2 lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.\n6. Documented progression according to the IMWG criteria during or after the last line of therapy.\n7. Evidence of at least a partial response according to the IMWG criteria to at least 1 previous line of therapy.\n8. ECOG score 0-2.\n\nExclusion Criteria:\n\n1. Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.\n2. Use of any investigational medicinal products or medical devices within 30 days or 5 half-lives (whichever is longer) prior to the expected start of the study therapy or planned use of investigational medicinal products or medical devices during participation in this study, except for the use described in this Protocol.\n3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the expected start of the study therapy or a history of allogenic stem cell transplantation, regardless of when it was performed.\n4. Planned hematopoietic stem cell transplantation before disease progression during this study.\n5. A history of other malignancies within 5 years before screening, excluding squamous and basal cell skin cancers, carcinoma in situ of the cervix or breast, or other malignancies, which, in the opinion of the Investigator, have been adequately treated and have a minimal risk of recurrence within 5 years.\n6. Concomitant diseases and\u002For conditions that significantly increase the risk of AEs during the study:\n\n   * Stable angina pectoris, functional class III-IV.\n   * Unstable angina and\u002For myocardial infarction within less than 6 months before the expected start of the study therapy.\n   * Chronic heart failure, NYHA class III-IV;\n   * Clinically significant (in the Investigator's opinion) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the expected start of the study therapy);\n   * Moderate to severe asthma, grade III-IV chronic obstructive pulmonary disease, a history of angioedema, severe respiratory failure;\n   * Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, or psoriasis) that do not require systemic therapy are eligible);\n   * Any infection within 14 days prior to the expected start of the study therapy, requiring systemic etiotropic therapy or which, in the opinion of the Investigator, may increase the risk of infectious complications;\n   * Any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.\n7. Subjects with amyloidosis.\n8. Clinical signs of meningeal involvement of multiple myeloma.\n9. HIV infection, active HBV infection, hepatitis C.\n10. Major surgery within less than 14 days prior to the expected start of the study therapy, incomplete recovery from surgery, or planned surgery during participation in the study.\n11. Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period and within 180 days after receiving the last dose of the IP.",{"count":21,"type":22},[25],"The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and\u002For refractory multiple myeloma.",[29],"2025-02-03",{"date":525,"type":37},"2025-02-04",{"date":527,"type":37},"2024-12-26",{"date":529,"type":22},"2028-07",{"name":531,"class":44},"Biocad",20,{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":369,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":548,"locationsCount":91},"100571285","early-phase-1-a-study-of-ct0596-in-relapsedrefractory-multiple-myeloma-and-relapsedrefractory-plasma-cell-leukemia-100571285","NCT06718270","a Study of CT0596 in Relapsed\u002FRefractory Multiple Myeloma and Relapsed\u002FRefractory Plasma Cell Leukemia","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be enrolled:\n\n1. Patients must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the trial visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.\n2. Age ≥ 18 years;\n3. Patients with R\u002FRMM who have received at least 3 prior lines of therapy, including at least 1 proteasome inhibitor and at least 1 immunomodulator (IMiD). Patients with RRpPCL had received at least 1 prior line of therapy. Number of lines of therapy was defined according to the guidelines provided in Rajkuma\\[1\\]r 2015 . Patients must have received at least 1 complete cycle of therapy for each line of therapy.\n4. According to multiple myeloma IMWG 2016 and plasma cell leukemia IMWG 2013, patients must have progressive disease following or during the last treatment.\n5. Patients must have measurable disease based on at least one of the following parameters:\n6. Expected survival \\> 12 weeks;\n7. Eastern Cooperative Oncology Group (ECOG) score 0- 1 ;\n8. Patients should meet the following test results\n9. Female patients of childbearing potential must have a negative pregnancy test at screening and prior to receiving lymphodepletion therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study ;Male patients are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited within 1 year following study treatment infusion for all male patients during the study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Patient has any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the patient to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n3. Patients seropositive for HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and or nucleic acid testing;\n4. Patients with any uncontrolled active infection, including but not limited to patients with active tuberculosis (investigator 's judgment);\n5. Toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;\n6. Previous allogeneic stem cell transplantation; autologous stem cell transplantation within 12 weeks prior to signing informed consent;\n7. Have received treatment for the disease within 14 days before informed consent\n8. Have received cell therapy within 28 days before informed consent.\n9. Systemic glucocorticoids equivalent to \\> 15 mg\u002Fday prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;\n10. Vaccination with live attenuated vaccines , inactivated vaccines or RNA vaccines within 4 weeks prior to informed consent;\n11. Allergic or intolerant to lymphodepletion, tocilizumab, or allergic to components (DMSO) in CT0596 CART cell infusion preparation; or previous history of other serious allergies such as anaphylactic shock;\n12. Patients Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at Screening;\n13. Patients with any of the following cardiac conditions within 6 months prior to screening:\n14. Patients who require supplemental oxygen to maintain oxygen saturation \\> 92%; or Patients with known or suspected COPD who have Forced Expiratory Volume in 1 second (FEV1) \\\u003C 50% of predicted normal on spirometry;\n15. Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive therapy;\n16. Patients with second primary malignancies are not eligible if the second primary malignancy has required treatment within the past 2 years or is not in complete remission. Exceptions include the following that have been successfully treated - nonmetastatic basal cell or squamous cell skin carcinoma, non-metastatic prostate cancer, carcinoma-in-situ of breast or cervix, non-muscle invasive bladder cancer\n17. Patients with symptomatic central nervous system (CNS) disease or suspected CNS metastases;\n18. Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract)",{"count":372,"type":22},[284],"This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R\u002FR MM and PCL.RRMM and RRpPCL",[29,376],[29,378,263],{"date":545,"type":37},"2024-12-12",{"date":111,"type":37},{"date":385,"type":22},{"name":549,"class":170},"Shanghai Changzheng Hospital",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":4},"100566791","a-real-world-observational-study-zevorcabtagene-autoleucel-injection-in-patients-with-relapsedrefractory-multiple-myeloma-100566791","NCT06659770","A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Subjects with refractory\u002Frelapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.\n3. Voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians.\n\nExclusion Criteria:\n\n1\\. There were no specific exclusion criteria for this study。",{"count":201,"type":22},"This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R\u002FR MM in the real world.",[29],"2024-10-24",{"date":561,"type":37},"2024-10-26",{"date":563,"type":22},"2024-10",{"date":385,"type":22},{"name":566,"class":44},"CARsgen Therapeutics Co., Ltd.",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":4},"100566464","phase-1-an-exploratory-study-of-rd140-injection-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100566464","NCT06655519","An Exploratory Study of RD140 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","An Exploratory Study of Fully Human Anti-B-Cell Maturation Antigen (BCMA)\u002FG Protein-coupled Receptor, Class C Group 5 Member (GPRC5D) Chimeric Antigen Receptor T Cells (RD140) in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:\n\n1. Age 18 to 75 years old, male or female;\n2. Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG), or diagnosed as primary plasma cell leukemia;\n3. Subjects have had at least 3 prior lines of therapy including at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody, or subjects who were refractory to the above treatments.\n4. Disease progression must be documented during or within 12 months following the most recent anti-tumor treatment (the progression for subjects whose last line treatment was CAR-T therapy was not limited to 12 months post-treatment);\n5. Presence of measurable lesion at screening as determined by any of the following criteria for subjects with MM:\n\n   * Serum M protein level: IgG type M protein ≥ 10 g\u002FL, or IgA, IgD, IgE, IgM type M protein ≥ 5 g\u002FL;\n   * Urine M protein level ≥ 200 mg\u002F24h;\n   * Light chain multiple myeloma without measurable M protein in serum or urine: Involved serum free light chain (sFLC) ≥ 100 mg\u002FL and abnormal serum κ\u002Fλ free light chain ratio；\n   * Serum M- protein, urine M- protein, or involved sFLC not meeting above criteria but bone marrow plasma cell percentage ≥30%;\n6. Subjects with primary plasma cell leukemia: peripheral blood plasma cell percentage≥5%at screening;\n7. ECOG score of 0 or 1;\n8. Estimated life expectancy ≥12 weeks;\n9. Subjects must have adequate organ function and meet all of the following laboratory test results prior to enrollment:\n\n   1. Blood routine: absolute neutrophil count (ANC) ≥ 1×10\\^9\u002FL (support with growth factor is allowed, but must not have received support treatment within 7 days before the laboratory test); Absolutely lymphocyte count (ALC) ≥0.3×10\\^9\u002FL; Platelets ≥50×10\\^9\u002FL (must not have received platelet transfusion support within 7 days before the laboratory test); Hemoglobin ≥60 g\u002FL(must not have received red blood cell \\[RBC\\] transfusion within 7 days before the laboratory test);\n   2. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5× Upper limit of normal value (ULN); Serum total bilirubin ≤1.5 ×ULN;\n   3. Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml\u002Fmin;\n   4. Coagulation function: fibrinogen ≥ 1.0g \u002FL; Activated partial thromboplastin time (aPTT) ≤1.5× ULN, Pro thrombin time (PT) ≤1.5× ULN;\n   5. Blood oxygen saturation(SaO2) \\>91%;\n   6. Left ventricular ejection fraction (LVEF) ≥ 50%;\n10. Subjects agree to take effective measures or drug contraceptive measures (excluding safe period contraception) after signing the ICF and within one year after CAR-T cell infusion;\n11. Subjects must sign an informed consent approved by the Ethics Committee before starting any screening procedures.\n\nExclusion Criteria:\n\n1. Subjects who are known to have Graft-Versus-host disease (GVHD) or need long-term immunosuppressive therapy;\n2. Subjects have received an autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks before leukapheresis or have a previous history of two times of auto-HSCT or previous history of an allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n3. Received targeted plasma cell therapy within 3 months before leukapheresis, or previous cell therapy products can still be detected in peripheral blood.\n4. Subjects have received any anti-tumor treatment as follows, prior to leukapheresis:\n\n   * Monoclonal antibody for multiple myeloma or plasma cell leukemia within 21 days, or;\n   * Cytotoxic chemotherapy or proteasome inhibitors within 14 days, or;\n   * Immunomodulators within 7 days, or;\n   * Received other anti-cancer therapy within 14 days or at least 5 half-lives\n5. Subjects require long-term use of glucocorticoids (defined as prednisone or equivalent \\> 20 mg\u002Fday) at a therapeutic dose during the study, physiologic replacement, topical, and inhaled steroids are permitted, nevertheless.\n6. Subjects with hypertension that cannot be controlled by medication;\n7. Sever cardiac disease including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), cardiac failure congestive (New York Heart Association \\[NYHA\\] class ≥ III), severe arrhythmia;\n8. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, renal, or metabolic disease requiring drug therapy ;\n9. Subjects has prior history of malignancies, other than MM and plasma cell leukemia within 5 years before screening, with the exception of radical carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of skin, localized cancer of prostate after radical prostatectomy, ductal carcinoma in situ of breast after radical mastectomy, or papillary thyroid carcinoma after radical thyroidectomy;\n10. Subjects with a history of organ transplantation;\n11. Subjects with suspected or known central nervous system (CNS) involvement with myeloma;\n12. Subjects with history of major surgery within 2 weeks prior to leukapheresis or planned to have surgery within 2 weeks after study treatment (except for subjects who were planned to have local anesthesia);\n13. Treated with other investigational products within 1 month prior to leukapheresis;\n14. Subjects have uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antimicrobial treatment) or requiring IV antimicrobials for management;\n15. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; Syphilis toluidine red unheated serum test (TRUST) and treponemal particle agglutination test (TPPA) were positive;\n16. Pregnant or breastfeeding women;\n17. Subjects have psychiatric disorders, conscious disorders, or central nervous system diseases;\n18. Any condition for which, at the discretion of investigators, participation would not be in the best interest of the subject.",{"count":149,"type":22},[57],"This is a single-center, open clinical study, divided into two phases of dose escalation and dose expansion, to observe the safety and efficacy of RD140 injection at different doses in patients with relapsed\u002Frefractory multiple myeloma or plasmacytic leukemia.",[29,235],[28,235,579],"RD140","2024-10-22",{"date":582,"type":37},"2024-10-23",{"date":584,"type":22},"2024-10-25",{"date":586,"type":22},"2041-07-05",{"name":588,"class":170},"Peking University People's Hospital",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":91},"100555682","safety-and-efficacy-of-anti-bcma-gprc5d-car-t-cells-therapy-in-the-treatment-of-rr-mm-100555682","NCT06515262","Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r\u002Fr MM","A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed\u002FRefractory Multiple Myeloma Who Received Three or More Lines of Therapy","Inclusion Criteria:\n\n1. The patient or his\u002Fher guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;\n2. Age 18-75 years old, gender unlimited;\n3. Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);\n4. The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g\u002FdL or Urine M-protein ≥ 200 mg\u002F24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg\u002FdL with an abnormal κ\u002Fλ ratio;\n5. Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;\n6. diagnosed as relapsed\u002Frefractory disease or primary refractory disease;\n7. The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;\n8. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);\n9. ECOG score 1-2 points and the expected survival period ≥ 3 months;\n10. Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n    1. Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;\n    2. Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    3. Hemoglobin (Hb) ≥ 50 g\u002FL without prior blood transfusion within 7 days;\n    4. Baseline peripheral oxygen saturation \\> 92%;\n    5. Corrected serum calcium ≤ 12.5 mg\u002FdL (≤ 3.1 mmol\u002FL) or free (ionized, ionic) calcium ≤ 6.5 mg\u002FdL (≤ 1.6 mmol\u002FL);\n    6. Left ventricular ejection fraction (LVEF) \\> 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance;\n    7. Without clinically significant pleural effusion;\n11. Venous access could be established; without contraindications of apheresis.\n\nExclusion Criteria:\n\n1. Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;\n2. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;\n3. It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;\n4. Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;\n5. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution;\n6. Patients have a severe allergic history;\n7. Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure \\[New York Heart Association (NYHA) classification ≥ grade III\\];\n8. Systemic diseases judged by researchers to be unstable: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;\n9. Patients with acute\u002Fchronic graft-versus-host disease (GVHD) or requiring immunosuppressive therapy for GVHD within 6 months prior to screening;\n10. Active autoimmune or inflammatory diseases of the nervous system;\n11. Patients develop oncology emergencies and need to be treated before screening or infusion;\n12. Uncontrolled infections that need antibiotics treatment;\n13. Exposure to hematopoietic growth factor of cells within 1-2 weeks before apheresis;\n14. Exposure to Corticosteriods or immunosuppressive agents within 2 weeks before apheresis;\n15. Patients receive a major surgical operation within 4 weeks before lymphodepletion or do not recover completely before the enrollment; or plan to receive a major surgical operation during the study period;\n16. Live attenuated vaccine within 4 weeks before screening;\n17. Persons with serious mental illness;\n18. Alcoholics or persons with a history of drug abuse;\n19. Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;\n20. Any unsuitable to participate in this trial judged by the investigator.",{"count":45,"type":22},[496],"This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.",[29],[601],"BCMA-GPRC5D CAR-T","2024-07-17",{"date":604,"type":37},"2024-07-23",{"date":606,"type":37},"2024-07-01",{"date":608,"type":22},"2026-12",{"name":610,"class":170},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China"]