[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660063":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":42,"interventions":49,"overallOfficials":54,"centralContacts":58,"locations":67,"responsibleParty":84,"collaborators":34,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":34,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":34,"enrollmentInfo":96,"targetDuration":34,"studyType":99,"phases":100,"briefSummary":92,"conditions":102,"keywords":105,"overallStatus":108,"whyStopped":34,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":34},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluate safety of GPRC5D CART","Incidence of Serious Adverse Events and Adverse Events of Special Interest related to study treatment","24 months following infusion",{"measure":14,"description":15,"timeFrame":16},"Evaluate dose dependent GPRC5D CART safety.","Determine the maximum tolerated single dose (MTD) in Phase 1a.","21 days following infusion",[18,21,24,27,30],{"measure":19,"description":20,"timeFrame":12},"Overall response rate","Overall Response Rate is defined by proportion of subjects with Partial Response or better per IMWG Criteria for MM, and Partial Response or better per Hematologic Response Criteria for AL",{"measure":22,"description":23,"timeFrame":12},"Complete response rate","Complete Response Rate is defined by proportion of subjects with Complete Response per IMWG Criteria for MM or per Hematologic Response Criteria for AL",{"measure":25,"description":26,"timeFrame":12},"Progression-Free Survival","Progression-Free Survival is defined as the time from the date of the initial infusion the date of first documented disease progression, or death due to any cause, whichever occurs first",{"measure":28,"description":29,"timeFrame":12},"Overall Survival","Overall Survival is defined by the date of the initial infusion to the date of the patient's death due to any cause",{"measure":31,"description":32,"timeFrame":33},"MRD negativity rate","MRD Negativity Rate is defined by proportion of subjects with MRD, defined as the absence of clonal plasma cells on bone marrow aspirate (minimum test sensitivity to detect 1 in 10x5 nucleated cells (10-5 threshold))","At 1, 6, 12, 18, and 24 months",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"NA","SINGLE_GROUP","The phase 1a dose-escalation part will follow a 3+3 design and include up to 4 dose level cohorts. This will be followed by a phase 1b expansion part, in which participants will be enrolled to receive treatment at the maximum tolerated dose (MTD).","TREATMENT",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"GPRC5D CART","EXPERIMENTAL","In the Phase 1a dose-escalation phase, eligible participants for Cohorts 1, 2, 3 and 4 will receive a single dose of either 50× 10˄6, 150 × 10˄6, 300 × 10˄6 or 450 × 10˄6 GPRC5D CART cells, respectively. The Phase 1b expansion part will enroll additional participants at the maximum tolerated dose, as determined during dose escalation.",[48],"Biological: GPRC5D CART",[50],{"type":51,"name":44,"description":52,"armGroupLabels":53,"otherNames":34},"BIOLOGICAL","The GPRC5D CART is defines as autologous bone marrow derived T-cells transduced with anti-GPRC5D CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human GPRC5D. The GPRC5D CART is provided cryopreserved.",[44],[55],{"name":56,"affiliation":5,"role":57},"Polina Stepensky, MD","PRINCIPAL_INVESTIGATOR",[59,63],{"name":56,"role":60,"phone":61,"phoneExt":34,"email":62},"CONTACT","972-2-6778353","Fainak@hadassah.org.il",{"name":64,"role":60,"phone":65,"phoneExt":34,"email":66},"Shlomit Kfir-Erenfeld, PhD","972-52-6260607","shlomiter@hadassah.org.il",[68],{"facility":69,"status":34,"city":70,"state":34,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Hadassah MO","Jerusalem","9574869","Israel","IL",{"type":75,"coordinates":76},"Point",[77,78],35.21633,31.76904,{"lat":78,"lon":77},[81],{"name":56,"role":60,"phone":82,"phoneExt":34,"email":83},"97226776679","Fainak@haddasah.org.il",{"type":57,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Polina Stepensky","Prof. Polina Stepensky, Director Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Organization","100660063","phase-1-phase-1ab-study-of-gprc5d-cart-therapy-in-relapsedrefractory-multiple-myeloma-and-light-chain-amyloidosis-100660063",false,"NCT07874334","Phase 1a\u002Fb Study of GPRC5D CART Therapy in Relapsed\u002FRefractory Multiple Myeloma and Light-chain Amyloidosis","A Phase 1a\u002Fb Open-Label Study to Evaluate Safety and Preliminary Efficacy of GPRC5D CART Therapy for the Treatment of Relapsed\u002FRefractory Multiple Myeloma and Light-chain Amyloidosis.","Inclusion Criteria:\n\n1. ≥18 years of age at the time of signing informed consent.\n2. Voluntarily signed informed consent form.\n3. Diagnosis of relapsed\u002Frefractory multiple myeloma or AL amyloidosis, with measurable disease at screening visit as follows:\n\n   Multiple Myeloma (at least one of the criteria below):\n   1. Serum M-protein greater or equal to 0.5 g\u002FdL.\n   2. Positive test for urine M-protein.\n   3. Serum free light chain (FLC) assay: involved FLC level greater or equal to 3 mg\u002FdL (30 mg\u002FL) provided serum FLC ratio is abnormal.\n   4. A biopsy- or PET-CT- proven evaluable plasmacytoma\\*.\n   5. Bone marrow plasma cells \\> 10% of total bone marrow cells\\*.\n   6. Non secretory patient will be allowed provided they have measurable disease by PET-CT or MRI or bone marrow aspiration, as designated\\*.\n\n      * Results pre-dating the Screening visit by up to 28 days may be used to establish eligibility AL Amyloidosis Serum free light chain (FLC) assay: involved FLC level greater or equal to 3 mg\u002FdL (30 mg\u002FL) provided serum FLC ratio is abnormal.\n4. Prior Exposure:\n\n   Multiple Myeloma: Subject must have been exposed to at least 3 prior lines of therapy including the following agents:\n   1. proteasome inhibitor\n   2. immunomodulatory (IMiDs) drug\n   3. anti-CD38 antibody\n\n   AL Amyloidosis: Subject have been exposed to 2 prior lines of therapy which include\u002Fs the following agents:\n   1. proteasome inhibitor\n   2. anti-CD38 antibody\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n6. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n7. Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy.\n8. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n9. Subjects who have previously undergone allogenic stem cell transplantation are without evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study.\n10. Subjects with Absolute Lymphocyte Count (ALC) \\> 0.3 × 109\u002FL\n\nExclusion Criteria:\n\n1. Known bulky central nervous system disease.\n2. Inadequate hepatic function defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN) and direct bilirubin \\> 4x ULN.\n3. Inadequate renal function defined by serum creatinine clearance\u002Festimated clearance of \\\u003C20 (ml\u002Fmin).\n4. International ratio (INR) or partial thromboplastin time (PTT) \\> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).\n5. Inadequate bone marrow function defined by absolute neutrophil count (ANC) \\\u003C 1000 cells\u002Fmm3, platelet count \\\u003C 30,000 mm3, or hemoglobin \\\u003C 8 g\u002FdL.\n6. Echocardiogram with left ventricular ejection fraction \\\u003C 40%.\n7. Ongoing treatment with chronic immunosuppressant or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg\u002Fm2\u002Fd hydrocortisone or equivalent)\n8. Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions.\n9. Known human immunodeficiency virus (HIV) positive status.\n10. Active Hepatitis B or Hepatitis C infections.\n11. Active CMV infection.\n12. Have suffered from a stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control and is not expected to resolve or stabilize within 3 months.\n13. Chronic atrial fibrillation with uncontrolled heart rate.\n14. Second primary malignancy that has required therapy in the last 2 years or is not in complete remission. This exclusion criterion does not exclude the following subjects: successfully treated non- metastatic basal cell or squamous cell skin carcinoma, or prostate cancer under control with hormonal therapy\n15. Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:\n\n    1. Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis).\n    2. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days\n    3. Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n16. Pregnant or lactating women.\n17. Contraindication to a study treatment\u002Fprocedure or is anticipated to receive treatment\u002Fprocedure that may preclude performance of study procedures.\n18. Subjects with Absolute Lymphocyte Count (ALC) ≤0.3 × 109\u002FL or \\\u003C 300 cells\u002Fmm3 (due to potential challenges with producing CART cells), per investigator judgement","ALL","18 Years",{"count":97,"type":98},160,"ESTIMATED","INTERVENTIONAL",[101],"PHASE1",[103,104],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)","Light-Chain Amyloidosis",[106,107],"Multiple Myeloma","Amyloidosis","NOT_YET_RECRUITING","2026-10-08",{"date":111,"type":112},"2026-10-14","ACTUAL",{"date":114,"type":98},"2026-09-15",{"date":116,"type":98},"2032-12-31",{"name":5,"class":6},1]