Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:09 AM
Study NCT ID:
NCT07346105
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2026-01-16
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'TEMPORARILY_NOT_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Hematopoietic stem cell transplantation', 'Acute leukemia', 'Myelodysplastic syndromes', 'Matched related donor', 'Matched unrelated donor', 'Myelodysplastic syndrome'], 'conditions': ['Hematologic Malignancies', 'Acute Myeloid Leukemia', 'Acute Lymphoid Leukemia', 'Myelodysplastic Syndrome', 'Mixed Phenotype Acute Leukemia']}, 'referencesModule': {'references': [{'pmid': '41385341', 'type': 'BACKGROUND', 'citation': 'Meyer EH, Salhotra A, Gandhi AP, Pantin J, Patel SS, Hoeg RT, Gomez-Arteaga A, Faramand R, Tamari R, Waller EK, Kosuri S, Jimenez Jimenez AM, Holter-Chakrabarty J, Dholaria B, Chen YB, Hamilton BK, Magenau J, Eghtedar A, Murray JM, Pavlova A, Fernhoff NB, McClellan JS, Killian MS, Li A, Negrin RS, Oliai C. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026 Mar 12;147(11):1168-1177. doi: 10.1182/blood.2025031313.'}]}, 'descriptionModule': {'briefSummary': 'This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Serious adverse events (SAEs) occurring during the safety reporting period (defined as the day the recipient receives the Orca-T HSPC drug product through day +365 after transplantation or until initiation of new anticancer therapy, whichever occurs sooner) will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': "Inclusion Criteria:\n\nRecipients in this EAP must meet all of the following criteria:\n\n1. Commercial Orca-T was prescribed to the patient by their treating physician.\n2. The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry.\n3. The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria.\n4. Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.\n5. Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation.\n\nExclusion Criteria:\n\nRecipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible."}, 'identificationModule': {'nctId': 'NCT07346105', 'briefTitle': 'Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orca Biosystems, Inc.'}, 'officialTitle': 'An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release', 'orgStudyIdInfo': {'id': 'Orca-T OOS EAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Orca-T', 'type': 'BIOLOGICAL', 'description': 'Orca-T that does not meet commercial release specifications'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orca Biosystems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}