Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
NCT ID: NCT04013685
Last Updated: 2025-05-02
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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ACTIVE_NOT_RECRUITING
PHASE1
255 participants
INTERVENTIONAL
2019-11-21
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subjects with Acute Leukemia or Myelodysplastic Syndrome, or BPDCN
This is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product.
Orca-T
an allogeneic stem cell and T-cell immunotherapy biologic
Interventions
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Orca-T
an allogeneic stem cell and T-cell immunotherapy biologic
Eligibility Criteria
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Inclusion Criteria
1. Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:
A) Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia who are not in CR or CRi (active disease) and/or MDS with \>10% to \<20% bone marrow blast burden (ages 18 to 75 years)
B) Acute leukemia in CR/CRi or MDS that is DRI intermediate to high risk (ages 66 to 75 years)
C) BPDCN (ages 18 to 65 years)
D) Participants aged 18 to 65 who would be eligible for the Phase 3 component of Precision-T except for mild impairments of renal and/or hepatic function as defined by an eGFR of 50 to \<60 mL/min and/or a total bilirubin of \>ULN to ≤2 x ULN and diagnosed with either of the following:
i. Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia that is in CR/CRi and DRI intermediate to high risk
a) MDS that is DRI intermediate to high risk
E) Acute or chronic leukemia in remission that is DRI low risk (ages 18 to 65 years), including the following:
i. CML in chronic phase but with a history of accelerated phase or blast crisis or who are resistant to or intolerant of more than 1 first- and second-generation tyrosine kinase inhibitors
ii. Acute myeloid leukemia (AML) with inv(16) without accompanying complex cytogenetics
2. Patients must be matched to a 8/8 HLA-matched related or unrelated donor
3. Estimated glomerular filtration rate (eGFR) \> 50 mL/minute
4. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
5. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
6. Total bilirubin \< 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST \< 3 times ULN
Exclusion Criteria
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. Pre-planned donor lymphocyte infusion (DLI)
4. Planned pharmaceutical in vivo or ex vivo T cell depletion
5. Positive for anti-donor HLA antibodies against an allele in the selected donor
6. Karnofsky performance score \< 70%
7. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \> 4
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 HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
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
12. Women who are pregnant or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
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Orca Biosystems, Inc.
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Davis
Sacramento, California, United States
Stanford Health Care
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
Massachusetts
Boston, Massachusetts, United States
University of Michigan Health System - Michigan Medicine
Ann Arbor, Michigan, United States
Weill Cornell Medicine - New York-Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health & Sciences University - Knight Cancer Institute
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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Precision-T (PhIb component)
Identifier Type: -
Identifier Source: org_study_id
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