[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651500":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":141,"centralContacts":145,"locations":152,"responsibleParty":170,"collaborators":172,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":150,"eligibilityCriteria":185,"healthyVolunteers":186,"sex":187,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":150,"studyType":193,"phases":194,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":202,"whyStopped":150,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (Orca-Q, thiotepa, busulfan, fludarabine)","EXPERIMENTAL","Recipient participants receive thiotepa IV over 3 hours on days -7 and -6, busulfan IV over 3 hours on days -5 to -3, fludarabine IV over 30 minutes on days -5 to -2, Orca-Q prime IV on day 0, followed by Orca-Q supplement IV on day 0 or 1 in the absence of disease progression or unacceptable toxicity.",[13,14,15,16,17,18],"Biological: Allogeneic Defined Hematopoietic Stem Cells\u002FImmune Cells","Drug: Busulfan","Biological: Filgrastim","Drug: Fludarabine","Drug: Granulocyte Colony-Stimulating Factor","Drug: Thiotepa",[20,29,33,67,92,97,109],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Allogeneic Defined Hematopoietic Stem Cells\u002FImmune Cells","Given Orca-Q prime IV",[9],[26,27,28],"Allogeneic Defined HSCs\u002FImmune Cells","Allogeneic Defined Stem and Immune Cells","Orca-Q",{"type":21,"name":22,"description":30,"armGroupLabels":31,"otherNames":32},"Given Orca-Q supplement IV",[9],[26,27,28],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Busulfan","Given IV",[9],[39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"1, 4-Bis[methanesulfonoxy]butane","BUS","Busilvex","Bussulfam","Busulfanum","Busulfex","Busulphan","CB 2041","CB-2041","Glyzophrol","GT 41","GT-41","Joacamine","Methanesulfonic Acid Tetramethylene Ester","Methanesulfonic acid, tetramethylene ester","Mielucin","Misulban","Misulfan","Mitosan","Myeleukon","Myeloleukon","Myelosan","Mylecytan","Myleran","Sulfabutin","Tetramethylene Bis(methanesulfonate)","Tetramethylene bis[methanesulfonate]","WR-19508",{"type":21,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Filgrastim","Given SC",[9],[72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"Filgrastim Biosimilar Filgrastim-sndz","Filgrastim Biosimilar Tbo-filgrastim","Filgrastim XM02","Filgrastim-aafi","Filgrastim-ayow","Filgrastim-sndz","G-CSF","Granix","Neupogen","Neutroval","Nivestim","Nivestym","r-metHuG-CSF","Recombinant Methionyl Human Granulocyte Colony Stimulating Factor","Releuko","rG-CSF","Tbo-filgrastim","Tevagrastim","XM02","Zarxio",{"type":34,"name":93,"description":36,"armGroupLabels":94,"otherNames":95},"Fludarabine",[9],[96],"Fluradosa",{"type":34,"name":98,"description":69,"armGroupLabels":99,"otherNames":100},"Granulocyte Colony-Stimulating Factor",[9],[101,102,103,104,105,78,106,107,108],"Colony Stimulating Factor 3","Colony-Stimulating Factor (Granulocyte)","Colony-Stimulating Factor 3","CSF3","G CSF","GCSF","Granulocyte Colony Stimulating Factor","Pluripoietin",{"type":34,"name":110,"description":36,"armGroupLabels":111,"otherNames":112},"Thiotepa",[9],[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140],"1,1',1''-Phosphinothioylidynetrisaziridine","Girostan","N,N', N''-Triethylenethiophosphoramide","Oncotiotepa","SH 105","SH-105","SH105","STEPA","Tepadina","Tepylute","TESPA","Tespamin","Tespamine","Thio-Tepa","Thiofosfamide","Thiofozil","Thiophosphamide","Thiophosphoamide","Thiophosphoramide","Thiotef","Tifosyl","TIO TEF","Tio-tef","Triethylene Thiophosphoramide","Triethylenethiophosphoramide","Tris(1-aziridinyl)phosphine sulfide","TSPA","WR 45312",[142],{"name":143,"affiliation":5,"role":144},"Mehrdad Abedi","PRINCIPAL_INVESTIGATOR",[146],{"name":147,"role":148,"phone":149,"phoneExt":150,"email":151},"Office of Clinical Research","CONTACT","916-382-6970",null,"OCRReferral@health.ucdavis.edu",[153],{"facility":154,"status":150,"city":155,"state":156,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":165,"contacts":166},"University of California Davis Comprehensive Cancer Center","Sacramento","California","95817","United States","US",{"type":161,"coordinates":162},"Point",[163,164],-121.4944,38.58157,{"lat":164,"lon":163},[167,168],{"name":147,"role":148,"phone":149,"phoneExt":150,"email":151},{"name":169,"role":144,"phone":150,"phoneExt":150,"email":150},"Mehrdad Abedi, MD",{"type":171,"investigatorFullName":150,"investigatorTitle":150,"investigatorAffiliation":150,"oldNameTitle":150,"oldOrganization":150},"SPONSOR",[173,176],{"name":174,"class":175},"National Cancer Institute (NCI)","NIH",{"name":177,"class":178},"Orca Biosystems, Inc.","INDUSTRY","100651500","phase-1-allogeneic-orca-q-stem-cell-transplant-for-the-treatment-of-relapsed-and-refractory-high-risk-multiple-myeloma-100651500",false,"NCT07759102","Allogeneic ORCA-Q Stem Cell Transplant for the Treatment of Relapsed and Refractory High Risk Multiple Myeloma","A Phase I Study to Evaluate the Safety and Efficacy of ORCA-Q Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed\u002F Refractory High Risk Multiple Myeloma","Inclusion Criteria:\n\n* Ability to understand and sign informed consent\n* Age ≥ 18 years and ≤ 65 years\n* Patients should be in very good partial response (VGPR) (5% or less plasma cells in the marrow) or better response status at the time of stem cell transplant with no evidence of central nervous system (CNS) disease. Patients in complete response (CR) should have minimal residual disease (MRD) positivity\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1; or Karnofsky performance status (KPS) of ≥ 70%\n* ≥ 60 days washout period from the last dose of an anti-CD38 antibody before the allogeneic transplant\n* ≥ 6 months washout period from the last autologous transplant before the allogeneic transplant\n* Related or unrelated donors available as follows:\n\n  * Sibling donor who is a 7\u002F8 mismatched or 8\u002F8 matched for human leukocyte antigen (HLA)-A, -B, -C, -DRB1\n  * Matched unrelated donor who is a 7\u002F8 mismatched or 8\u002F8 matched for HLA-A, -B, -C, and -DRB1\n* A diagnosis of relapsed or refractory defined as:\n\n  * Primary refractory disease or relapse \\\u003C 12 months following initial therapy that includes an immunomodulatory agent, proteasome inhibitor, anti-CD38 monoclonal antibody, and corticosteroid\n  * Relapse \\\u003C 12 months after first autologous stem cell transplant\n  * Failing to achieve complete response or relapsing after chimeric antigen receptor (CAR)-T treatment or bispecific antibodies; or indicated but ineligible for either bispecific antibodies or CAR-T cells due to low blood counts\n  * No appropriate standard of care therapy per investigator\n* A diagnosis of ultra-high risk multiple myeloma defined as having at least one or more of these criteria:\n\n  * Biallelic TP53 inactivation\n  * ≥ 2 HRCAs: del(17p), TP53 mutation, t(4;14), t(14;16), t(14;20), gain(1q), amp(1q), del(1p32)\n  * Biallelic del(1p32)\n  * High-risk gene expression profile signature\n  * Extramedullary disease excluding intramedullary plasmacytoma with extraosseous extension and active CNS disease\n  * ≥ 2% circulating plasma cells\n* Creatinine clearance of ≥ 50 mL\u002Fmin as estimated by Cockcroft-Gault\n* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in subjects with Gilbert's syndrome in whom total bilirubin ≤ 3 times ULN\n* Alanine transaminase (ALT\u002Fserum glutamic pyruvic transaminase \\[SGPT\\]) and aspartate aminotransferase (AST\u002Fserum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 3 x the upper limit of normal (ULN) or ≤ 5 x ULN if documented liver involvement by disease\n* Estimated glomerular filtration rate (eGFR) \\> 50mL\u002Fminute. Creatinine clearance of ≥ 30 mL\u002Fmin is allowed in patients eligible for no tacrolimus immunosuppression\n* Pulmonary function as defined by diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%\n* Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram, or radionuclide scan (multigated acquisition scan \\[MUGA\\])\n* Corrected diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%\n* Individuals of childbearing potential or those with partners of childbearing potential must agree to use methods of contraception for the duration of study participation or be surgically sterilized\n* Stated ability and willingness to adhere to the study visit schedule and protocol requirements\n* DONOR: Ability to understand and sign informed consent\n* DONOR: Age ≥ 16 and ≤ 35 years at time of enrollment for unrelated donors and Age ≥ 16 and ≤ 50 years for related donors\n* DONOR: Either one of the following scenarios:\n\n  * Sibling donor who is a 7\u002F8 mismatched or 8\u002F8 matched for HLA-A, -B, -C, and -DRB1, all typed using deoxyribonucleic acid (DNA)-based high-resolution methods\n  * Unrelated donor who is 7\u002F8 mismatched or 8\u002F8 matched HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods\n* DONOR: Willing to donate stem cell mobilized mononuclear cells for up to two consecutive days\n* DONOR: Able to donate within the continental United States at a site that will employ a Spectra Optia Apheresis System for post-mobilization apheresis\n* DONOR: Meets federal eligibility criteria for donors of viable, leukocyte-rich cells or tissues and all relevant Food and Drug Administration (FDA) Guidance for Industry (Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 2007; Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum \\[syphilis\\], 2015; Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 2016; Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products \\[HCT\u002FPs\\], 2016)\n* DONOR: Donors determined to be ineligible, based on the results of required testing and\u002For screening, may nonetheless be included if either applies:\n\n  * The donor is a first-degree blood relative of the recipient\n  * Urgent medical need, meaning no comparable human cell product is available, and the recipient is likely to suffer death or serious morbidity without the human cell product, as attested by the investigator\n  * Meets any other criteria for donation as specified by standard National Marrow Donor Program (NMDP) guidelines (NMDP donors) or institutional standards (non-NMDP donors)\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic cell transplantation (HCT)\n* Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy), peri-transplant anti-thymocyte globulin (ATG), or alemtuzumab\n* Positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n  * A positive crossmatch test of any titer; or\n  * The presence of anti-donor HLA antibody to any HLA locus\n* Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \\> 4\n* Uncontrolled bacterial, viral, or fungal infections (currently taking antimicrobial therapy and with no clinical improvement) at time of enrollment\n* Seropositive for HIV-1 or -2, human T-cell lymphotropic virus (HTLV)-1 or -2\n* Documented allergy or documented hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins\n* Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers or any carcinoma in situ that have been curatively resected\n* History of idiopathic or secondary myelofibrosis\n* Individuals who are pregnant or breastfeeding\n* Any condition that would prohibit the understanding or rendering of informed consent\n* Any condition that in the opinion of the investigator would interfere with the subject's safety or compliance while on study\n* A diagnosis of polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome\n* DONOR: Evidence of uncontrolled, active infection\n* DONOR: Seropositive for HIV-1 or -2, HTLV-1 or -2\n* DONOR: Positive for hepatitis B (HBV) surface antigen (HBsAg), total anti-hepatitis B core antibody (HBcAb, immunoglobulin \\[I\\]gG and IgM), HBV nucleic acid testing (NAT), anti-hepatitis C (HCV) antibody, or HCV NAT\n* DONOR: Aberrant CD45RA isoform expression\n* DONOR: Women who are pregnant or breastfeeding",true,"ALL","18 Years","65 Years",{"count":191,"type":192},20,"ESTIMATED","INTERVENTIONAL",[195],"PHASE1","This phase I trial tests the effect of allogeneic Orca-Q stem cell transplant in treating patients with high-risk multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). An allogeneic (donor) transplant uses blood forming stem cells (graft) from a matched donor. When the healthy blood forming (stem) cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease \\[GVHD\\]). Orca-Q includes some T cells (a type a white blood cell) that are thought to help prevent some of the known complications as well as help attack the cancer cells. However, Orca-Q removes a specific type of T cell called naive T lymphocytes. Naive T cells may contribute to GVHD and are not thought to be required for the success of the treatment. Removing these cells may help reduce the frequency or severity of GVHD. Giving chemotherapy, such as thiotepa, busulfan, and fludarabine, before a donor stem cell transplant helps kill cancer cells in the body and prepare the body to receive the transplant graft. Giving allogeneic Orca-Q may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory (R\u002FR) high-risk multiple myeloma.",[198,199],"Recurrent Multiple Myeloma","Refractory Multiple Myeloma",[201],"ORCA-Q","NOT_YET_RECRUITING","2026-08-05",{"date":205,"type":206},"2026-08-12","ACTUAL",{"date":208,"type":192},"2026-09-01",{"date":210,"type":192},"2033-09-01",{"name":5,"class":6},1]