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Official Title
A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies
Phase
Phase 1
Sponsor
Orca Biosystems, Inc.
Enrollment
300
Timeline
Apr 2019 → Dec 2027
About This Study
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.
Eligibility Criteria
Inclusion Criteria
- 1Age at the time of enrollment:
- 2For MAC with fully matched donor (Arm A with 8/8 donor and Arm C) and NMA/RIC: Age ≥ 12 and ≤ 78 years
- 3For MAC with mismatched donors (Arm A with 7/8 donor and Arm B): Age ≥ 12 and ≤ 65 years
- 4Diagnosed 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)
- 5Indicated for allogeneic hematopoietic stem cell transplant (alloHCT)
- 6Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor
- 7Estimated glomerular filtration rate (eGFR) \> 50 mL/minute (MAC with tacrolimus) or \> 30 mL/minute (NMA/RIC or MAC without tacrolimus)
- 8Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA/RIC)
- 9Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA/RIC
- 10Liver 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)
- 11Participants enrolling on NMA/RIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)
Exclusion Criteria
- 1Prior alloHCT
- 2Currently 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
- 3Planned donor lymphocyte infusion (DLI)
- 4Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab
- 5Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
- 6Low performance score: For MAC: Karnofsky Performance Score (KPS) \< 70 percent, For NMA/RIC: \<60 percent
- 7High HCT-specific Comorbidity Index (HCT-CI): For MAC \> 4, For NMA/RIC \>6
- 8Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
- 9Seropositive 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)
- 10Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
- 11Concurrent 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
- 12History of idiopathic or secondary myelofibrosis
- 13Women who are pregnant or breastfeeding
Locations
8 sites participating in this study
Emory University
Atlanta, Georgia 30322
City of Hope
Duarte, California 91010
Amandeep Salhotra, MD
UC Davis
Sacramento, California 95817
Mehrdad Abedi, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →