[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Orca Biosystems, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100347357","phase-1-a-phase-1-study-of-orca-q-in-recipients-undergoing-allogeneic-transplantation-for-hematologic-malignancies-100347357",false,"NCT03802695","A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies","A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies","Key Inclusion Criteria:\n\n1. Age at the time of enrollment:\n\n   1. For MAC with fully matched donor (Arm A with 8\u002F8 donor and Arm C) and NMA\u002FRIC: Age ≥ 12 and ≤ 78 years\n   2. For MAC with mismatched donors (Arm A with 7\u002F8 donor and Arm B): Age ≥ 12 and ≤ 65 years\n2. Diagnosed acute myeloid, lymphoblastic or mixed phenotype leukemia, or high or very high risk myelodysplastic syndrome (MDS) either in complete remission (CR) or with ≤ 10 percent of blast cells in bone marrow (BM)\n3. Indicated for allogeneic hematopoietic stem cell transplant (alloHCT)\n4. Matched to a 8\u002F8 or 7\u002F8 related or unrelated donor, or to a related haploidentical donor\n5. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fminute (MAC with tacrolimus) or \\> 30 mL\u002Fminute (NMA\u002FRIC or MAC without tacrolimus)\n6. Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA\u002FRIC)\n7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA\u002FRIC\n8. Liver function: Total bilirubin \\\u003C 1.5 times upper limit of normal (ULN) (MAC) or \\\u003C 3 times ULN (NMA\u002FRIC); alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\\u003C 3 times ULN (MAC) or \\\u003C 5 times ULN (NMA\u002FRIC)\n9. Participants enrolling on NMA\u002FRIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)\n\nKey Exclusion Criteria:\n\n1. Prior alloHCT\n2. Currently receiving corticosteroids or other immunosuppressive therapy except for approved disease-specific therapy for the patient's underlying hematologic malignancy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed\n3. Planned donor lymphocyte infusion (DLI)\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab\n5. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor\n6. Low performance score: For MAC: Karnofsky Performance Score (KPS) \\\u003C 70 percent, For NMA\u002FRIC: \\\u003C60 percent\n7. High HCT-specific Comorbidity Index (HCT-CI): For MAC \\> 4, For NMA\u002FRIC \\>6\n8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment\n9. Seropositive for human immunodeficiency virus (HIV)-1 or -2, human T-lymphotropic virus (HTLV)-1 or -2 or Hepatitis B surface antigen (HbsAg) or anti-Hepatitis C virus (HCV) antibody (Ab)\n10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment\n11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected. Patients with concurrent indolent hematologic malignancies that do not require active treatment and are under active surveillance only (such as CLL, low-grade lymphomas, smoldering MM, MZL) may be included with the approval of Medical Monitor\n12. History of idiopathic or secondary myelofibrosis\n13. Women who are pregnant or breastfeeding","ALL","12 Years","78 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts (\"OrcaGraft\"\u002F\"Orca-Q\") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.",[27,28,29,30],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Mixed Phenotype Acute Leukemia","Acute Lymphoblastic Leukemia","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2019-04-08",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"Orca Biosystems, Inc.","INDUSTRY",12,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100609581","phase-2-trial-of-orca-t-following-reduced-intensity-or-nonmyeloablative-conditioning-in-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100609581","NCT07216443","Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n1. Age ≥18 years at the time of enrollment\n2. Diagnosed with 1 of the following diseases:\n\n   1. Acute myeloid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease.\n   2. Myelodysplastic syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and\u002For therapy-related\u002Fsecondary MDS as defined by the World Health Organization (WHO) classification of myeloid malignancies, with ≤10% blast burden in the bone marrow.\n3. Planned to undergo 1 of the following preparative regimens as per Investigator discretion:\n\n   1. RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI\u002Fthiotepa\u002Ffludarabine\n   2. NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine\u002Fcyclophosphamide\u002FTBI\n4. Identified related or unrelated donor who is an 8\u002F8 match for HLA-A, -B, -C, and -DRB1\n5. Estimated glomerular filtration rate ≥30 mL\u002Fminute\n6. Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA)\n7. Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%\n8. Negative serum or urine β-HCG test in persons of childbearing potential\n9. Alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\\u003C5 times the upper limit of normal (ULN)\n10. Total bilirubin \\\u003C3 × ULN\n11. Deemed ineligible for a fully myeloablative alloHCT per assessment of the principal investigator\n\nExclusion Criteria:\n\n1. Prior alloHCT\n2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed.\n3. Planned donor lymphocyte infusion (DLI)\n4. Planned pharmaceutical in vivo or ex vivo T-cell depletion\n5. Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor\n6. Karnofsky performance score \\\u003C60%\n7. For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6\n8. Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment\n9. Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or HCV antibody unless previously treated with curative therapy and are HCV NAT negative\n10. Known allergy or hypersensitivity to or intolerance of tacrolimus\n11. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal, or Streptomyces avidinii proteins\n12. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment\n13. Concurrent malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected\n14. Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care\n15. Persons who are pregnant or breastfeeding\n16. Person of childbearing potential (POCBP) or men who have sexual contact with POCBP who are unwilling to use effective forms of birth control or abstinence for 1 year after transplantation.\n17. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the recipient's safe participation in and completion of the trial or which could affect compliance with the protocol or interpretation of results","18 Years",{"count":53,"type":21},80,[55],"PHASE2","This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).",[58,28,29],"Leukemia, Myeloid, Acute",[58,28,29,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"Therapy-Related Myelodysplastic Syndrome","Hematopoietic Stem Cell Transplantation","Humans","Graft vs Host Disease","SERENE-T","ORCA-T","Disease","Pathologic Processes","Neoplasms by Histologic Type","Neoplasms","Hematologic Diseases","Bone Marrow Diseases","Precancerous Conditions","Neoplasms by Site","Disease Attributes","Immunoproliferative Disorders","Immune System Diseases","Leukemia","Preleukemia","Hematologic Neoplasms","Syndrome","Acute Disease","2026-06-18",{"date":84,"type":35},"2026-06-23",{"date":86,"type":35},"2025-12-09",{"date":88,"type":21},"2028-12",{"name":41,"class":42},5,""]