A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
NCT ID: NCT03802695
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2019-04-08
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Recipients with human leukocyte antigen (HLA)-identical related or unrelated or 1-allele mismatched (7/8 alleles) unrelated donor undergoing myeloablative conditioning (MAC); with single- or dual-agent graft-versus-host disease (GVHD) prophylaxis given
OrcaGraft (Orca-Q)
engineered donor allograft
Arm B
Recipients with haploidentical-related donors undergoing MAC; with single- or dual-agent GVHD prophylaxis given
OrcaGraft (Orca-Q)
engineered donor allograft
Arm C
Recipients with an HLA-identical related or unrelated donor undergoing MAC; no GVHD prophylaxis given
OrcaGraft (Orca-Q)
engineered donor allograft
Arm D
Recipients with an HLA-identical related or unrelated donor undergoing non-myeloablative (NMA)/reduced intensity conditioning (RIC); with dual agent GVHD prophylaxis given
OrcaGraft (Orca-Q)
engineered donor allograft
Arm E
Recipients with 1-allele mismatched (7/8 alleles) unrelated donor undergoing NMA/RIC; with dual-agent GVHD prophylaxis given
OrcaGraft (Orca-Q)
engineered donor allograft
Arm F
Recipients with haploidentical-related donors undergoing NMA/RIC; with dual-agent GVHD prophylaxis given
OrcaGraft (Orca-Q)
engineered donor allograft
Interventions
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OrcaGraft (Orca-Q)
engineered donor allograft
Eligibility Criteria
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Inclusion Criteria
1. For MAC with fully matched donor (Arm A with 8/8 donor and Arm C) and NMA/RIC: Age ≥ 12 and ≤ 78 years
2. For MAC with mismatched donors (Arm A with 7/8 donor and Arm B): Age ≥ 12 and ≤ 65 years
2. 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)
3. Indicated for allogeneic hematopoietic stem cell transplant (alloHCT)
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 (MAC with tacrolimus) or \> 30 mL/minute (NMA/RIC or MAC without tacrolimus)
6. Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA/RIC)
7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA/RIC
8. 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)
9. Participants enrolling on NMA/RIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)
Exclusion Criteria
2. 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
3. Planned donor lymphocyte infusion (DLI)
4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab
5. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
6. Low performance score: For MAC: Karnofsky Performance Score (KPS) \< 70 percent, For NMA/RIC: \<60 percent
7. High HCT-specific Comorbidity Index (HCT-CI): For MAC \> 4, For NMA/RIC \>6
8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
9. 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)
10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
11. 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
12. History of idiopathic or secondary myelofibrosis
13. Women who are pregnant or breastfeeding
12 Years
78 Years
ALL
No
Sponsors
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Orca Biosystems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James S McClellan, MD, PhD
Role: STUDY_DIRECTOR
Orca Biosystems, Inc.
Locations
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UC Davis
Sacramento, California, United States
City of Hope
Duarte, California, United States
Stanford Health Care
Stanford, California, United States
Emory University
Atlanta, Georgia, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
Ohio State University
Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Amandeep Salhotra, MD
Role: primary
Mehrdad Abedi, MD
Role: primary
Robert Lowsky, MD
Role: primary
Samer Srour, MD
Role: primary
Other Identifiers
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OGFT001-001
Identifier Type: -
Identifier Source: org_study_id
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