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Precision-T: A Randomized Phase III Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (Orca-T)

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ClinicalTrials.gov Identifier: NCT05316701
Recruitment Status : Recruiting
First Posted : April 7, 2022
Last Update Posted : January 26, 2023
Information provided by (Responsible Party):
Orca Biosystems, Inc.

Brief Summary:
This study will compare the safety and efficacy between patients receiving an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) or standard-of-care (SOC) control in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation (MA-alloHCT) for hematologic malignancies. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoid Leukemia Mixed Phenotype Acute Leukemia Undifferentiated Leukemia High-risk Myelodysplastic Syndrome Acute Leukemia Therapy-Related Myelodysplastic Syndrome MDS Biological: Orca-T Biological: Standard-of-Care Phase 3

Detailed Description:
Cross reference NCT04013685

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The Phase III is a randomized, open-label, multicenter study comparing outcomes between patients receiving Orca-T followed by single-agent tacrolimus or standard-of-care (SOC) control followed by dual agent, tacrolimus-based Graft-versus-Host-Disease (GVHD) prophylaxis regimen
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III 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
Actual Study Start Date : June 21, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2028

Arm Intervention/treatment
Experimental: Orca-T
For patients randomized to the Orca-T arm, Orca-T will be administered after myeloablative conditioning regimen. Single-agent GVHD prophylaxis with tacrolimus will be administered following Tcon infusion (generally Day +3).
Biological: Orca-T
engineered donor allograft
Other Name: TregGraft

Active Comparator: Standard of Care alloHCT Control
For patients randomized to the standard-of-care control arm, an unmanipulated allograft derived from the peripheral blood of a matched donor will be administered after a myeloablative conditioning regimen. Dual-agent prophylaxis consisting of tacrolimus plus methotrexate will be administered starting on Day -3.
Biological: Standard-of-Care
unmanipulated donor allograft
Other Name: SOC

Primary Outcome Measures :
  1. Chronic Graft-versus-Host-Disease-free Survival [ Time Frame: Randomization through 730 days post transplant ]
    An event for this time-to-event outcome is defined as death by any cause or moderate to severe cGVHD as defined by NIH consensus criteria

Secondary Outcome Measures :
  1. Graft-versus-Host-Disease and Relapse-free survival (GRFS) [ Time Frame: Day 0 through 365 days post-transplant ]
    An event for this time-to-event outcome is defined as survival free of death from any cause, relapse, Grade 3-4 aGVHD (graded per MAGIC), and moderate to severe cGVHD (graded per NIH consensus criteria).

  2. Moderate to severe chronic graft-versus-host-disease [ Time Frame: Day 0 through 365 days post-transplant ]
    An event for this time-to-event outcome is defined as moderate to severe cGVHD as defined by NIH consensus criteria.

  3. Relapse-free survival [ Time Frame: Day 0 through 730 days post-transplant ]
    Survival free of death from relapse.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Matched to a related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and DRB1
  • Diagnosed with one of the following diseases:

    • Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease
    • Myelodysplastic syndromes (MDS) that are indicated for alloHSCT per 2017 International Expert Panel recommendations and/or have therapy-related/secondary MDS, with ≤ 10% blast burden in the bone marrow
  • Planned to undergo MA-alloHCT including one of the following myeloablative conditioning regimens:

    • TBI/Cy
    • TBI/Etoposide
    • BFT
  • 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%
  • Negative serum or urine beta-HCG test in females of childbearing potential
  • ALT/AST < 3 times ULN
  • Recipients in screening must screen negative for SARS-CoV-2 RNA using a PCR-based test
  • Disease Risk Index (DRI) overall risk categorization of intermediate or high
  • Total bilirubin ≤ upper limit of normal (ULN)
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute

Key Exclusion Criteria:

  • 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.
  • Planned donor lymphocyte infusion (DLI)
  • Planned pharmaceutical in vivo or ex vivo T cell depletion
  • Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor
  • Karnofsky performance score < 70%
  • Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
  • Uncontrolled bacterial, viral or fungal infections at time of enrollment
  • Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, Hepatitis C antibody
  • Known allergy or hypersensitivity to, or intolerance of, tacrolimus
  • Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins
  • 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
  • Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow up care
  • Women who are pregnant or breastfeeding
  • Women of childbearing potential (WOCBP) or men who have sexual contact with WOCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05316701

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Contact: James S McClellan, MD PhD 530 414 9743 info@orcabio.com

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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Amandeep Salhotra         
Ronald Regan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Caspian Oliai, MD         
Contact: Bruck Habtemariam       BHabtemariam@mednet.ucla.edu   
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Rasmus Hoeg         
Contact: Dara Feleciano, RN MSN       djfeleciano@ucdavis.edu   
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Contact: Everett Meyer, MD, PhD         
Contact: Lindsay Danley       lindsmd@stanford.edu   
United States, Florida
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Antonio M Jimenez, MD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Rawan Faramand, MD    888-663-3488    Rawan.Faramand@moffitt.org   
United States, Georgia
Winship Cancer Institute - Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, MD, PhD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Satyajit Kosuri, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yi-Bin Chen, MD    617-724-3456    ychen6@partners.org   
United States, New York
Weill Cornell Medicine - New York-Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: Alexandra Gomez Arteaga, MD         
Contact: Meredith Mullane, RN    212-746-0702    Met9042@med.cornell.edu   
United States, Oregon
Oregon Health & Sciences University - Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Arpita Gandhi, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Bhagirathbhai Dholaria, MD    615-343-6653      
Contact: Rohan Goel       rohan.w.goel@vumc.org   
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37239
Contact: Jeremy Pantin, MD    615-342-3385      
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Sagar Patel, MD         
Contact: Collind Boyington       Collind.boyington@hci.utah.edu   
Sponsors and Collaborators
Orca Biosystems, Inc.
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Responsible Party: Orca Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT05316701    
Other Study ID Numbers: Precision-T (PhIII component)
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orca Biosystems, Inc.:
hematopoietic stem cell transplantation
acute leukemia
Myelodysplastic syndromes
matched related donor
matched unrelated donor
myelodysplastic syndrome
Additional relevant MeSH terms:
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Hematologic Neoplasms
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Acute Disease
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Disease Attributes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases