Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
A Phase Ib Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft
1 other identifier
interventional
255
1 country
21
Brief Summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2019
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
November 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedMay 2, 2025
May 1, 2025
5.4 years
July 3, 2019
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The incidence of primary graft failure
The incidence of primary graft failure
365 days
The incidence of grade 3 or 4 aGVHD
The incidence of grade 3 or 4 aGVHD
180 days
Secondary Outcomes (5)
1-year overall survival (OS)
365 days
1 year graft-versus-host-disease-free and relapse-free survival (GRFS)
365 days
incidence and severity of acute and chronic graft vs host disease (GvHD)
365 days
incidence of serious infections
365 days
incidence of engraftment
28 days
Study Arms (1)
Subjects with Acute Leukemia or Myelodysplastic Syndrome, or BPDCN
EXPERIMENTALThis is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product.
Interventions
an allogeneic stem cell and T-cell immunotherapy biologic
Eligibility Criteria
You may qualify if:
- Recipients must meet all of the following criteria:
- 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
- Patients must be matched to a 8/8 HLA-matched related or unrelated donor
- Estimated glomerular filtration rate (eGFR) \> 50 mL/minute
- Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
- Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
- +1 more criteria
You may not qualify if:
- History of prior allogeneic HCT
- Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
- Pre-planned donor lymphocyte infusion (DLI)
- Planned pharmaceutical in vivo or ex vivo T cell depletion
- Positive for anti-donor HLA antibodies against an allele in the selected donor
- Karnofsky performance score \< 70%
- Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \> 4
- Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
- Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
- 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
- Women who are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
City of Hope
Duarte, California, 91010, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UC Davis
Sacramento, California, 95817, United States
Stanford Health Care
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Massachusetts
Boston, Massachusetts, 02114, United States
University of Michigan Health System - Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Weill Cornell Medicine - New York-Presbyterian Hospital
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Sciences University - Knight Cancer Institute
Portland, Oregon, 97239, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77054, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2019
First Posted
July 10, 2019
Study Start
November 21, 2019
Primary Completion
April 30, 2025
Study Completion (Estimated)
April 1, 2027
Last Updated
May 2, 2025
Record last verified: 2025-05