Status:
RECRUITING
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Lead Sponsor:
Orca Biosystems, Inc.
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
12-78 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transpla...
Eligibility Criteria
Inclusion
- Key
- Age at the time of enrollment:
- For MAC with fully matched donor (Arm A with 8/8 donor and Arm C) and NMA/RIC: Age ≥ 12 and ≤ 78 years
- For MAC with mismatched donors (Arm A with 7/8 donor and Arm B): Age ≥ 12 and ≤ 65 years
- 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)
- Indicated for allogeneic hematopoietic stem cell transplant (alloHCT)
- Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor
- Estimated glomerular filtration rate (eGFR) \> 50 mL/minute (MAC with tacrolimus) or \> 30 mL/minute (NMA/RIC or MAC without tacrolimus)
- Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA/RIC)
- Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA/RIC
- Liver function: Total bilirubin \< 1.5 times upper limit of normal (ULN) (MAC) or \< 3 times ULN (NMA/RIC); alanine transaminase (ALT)/aspartate transaminase (AST) \< 3 times ULN (MAC) or \< 5 times ULN (NMA/RIC)
- Participants enrolling on NMA/RIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)
- Key
Exclusion
- Prior alloHCT
- 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/day are allowed
- Planned donor lymphocyte infusion (DLI)
- Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab
- Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
- Low performance score: For MAC: Karnofsky Performance Score (KPS) \< 70 percent, For NMA/RIC: \<60 percent
- High HCT-specific Comorbidity Index (HCT-CI): For MAC \> 4, For NMA/RIC \>6
- Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
- 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)
- Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
- 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
- History of idiopathic or secondary myelofibrosis
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
April 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03802695
Start Date
April 8 2019
End Date
December 1 2027
Last Update
December 4 2025
Active Locations (8)
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1
City of Hope
Duarte, California, United States, 91010
2
UC Davis
Sacramento, California, United States, 95817
3
Stanford Health Care
Stanford, California, United States, 94305
4
Emory University
Atlanta, Georgia, United States, 30322