Clinical trial · Expanded Access
Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies
An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Mixed Phenotype Acute Leukemia | Mixed Phenotype Acute Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orca-T | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Recipients in this EAP must meet all of the following criteria: 1. Commercial Orca-T was prescribed to the patient by their treating physician. 2. The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry. 3. 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. 4. Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment. 5. Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation. Exclusion Criteria: Recipients 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.
References
Publications (1)
- BACKGROUNDMeyer 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. PMID 41385341