A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Launched by ORCA BIOSYSTEMS, INC. · Jan 10, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Orca-Q, which involves using specially engineered donor cells to help patients with certain blood cancers, such as acute myeloid leukemia and chronic myeloid leukemia. The goal is to see if this new approach is safe and effective for patients who are preparing to undergo a type of stem cell transplant known as myeloablative allogeneic hematopoietic cell transplantation. This trial is currently looking for participants aged 18 to 65 who have been diagnosed with specific types of blood cancers and are matched with a suitable donor.

If you or someone you know is eligible and chooses to participate, you can expect to receive close monitoring throughout the study to ensure your safety and health. It’s essential to know that participants must not have had a prior stem cell transplant or be receiving certain medications that suppress the immune system. The research team will provide detailed information about the trial and what participation entails, helping to ensure everyone feels comfortable and informed.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Age ≥ 18 and ≤ 65 years at the time of enrollment
• • 2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS), myelofibrosis, or chronic myeloid leukemia
• • 3. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
• • 4. Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor
• • 5. Estimated glomerular filtration rate (eGFR) \> 50 mL/minute
• • 6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
• • 7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
• • 8. Total bilirubin \< 1.5 times upper limit of normal (ULN) (\< 3 times if attributed to Gilbert's syndrome) and ALT/AST \< 3 times ULN
• Key Exclusion Criteria:
• • 1. Prior allogeneic HCT
• • 2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
• • 3. Planned donor lymphocyte infusion (DLI)
• • 4. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
• • 5. Karnofsky performance score \< 70% (Appendix 12.7)
• • 6. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \> 4 (Appendix 12.8)
• • 7. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
• • 8. Seropositive for HIV-1 or -2, HTLV-1 or -2
• • 9. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
• • 10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
• • 11. History of idiopathic or secondary myelofibrosis
• • 12. Women who are pregnant or breastfeeding