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NCT05316701 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-03-04

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. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)

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outcome · POSTED

Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC

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outcome · POSTED

Event-free at 12 Months for Overall Survival (OS)

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outcome · POSTED

Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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).
    intervention Names
    1. Biological: Orca-T
    label
    Orca-T
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Biological: Standard-of-Care
    label
    Standard of Care alloHCT Control
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Orca-T
    description
    an allogeneic stem cell and T-cell immunotherapy biologic
    name
    Orca-T
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Standard of Care alloHCT Control
    description
    unmanipulated donor allograft
    name
    Standard-of-Care
    other Names
    1. SOC
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
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 Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
187
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Event-free rate estimated at 12 months for cGFS per EAC, which is defined as the time from date of allogeneic hematopoietic cell transplantation (alloHCT) (ie, day 0) to date of death from any cause or first onset of moderate or severe chronic graft-versus-host disease (cGVHD) (graded per NIH consensus criteria), whichever was earliest, within 2 years after day 0. cGVHD was assessed and graded by EAC blinded to treatment assignment. Each participant in the study is followed for up to 730 days after transplant. Primary analysis was event driven (ie, when 56 participants had died or had moderate or severe cGVHD) and was not based on duration of follow-up. The analysis was conducted using all available data at the time that the 56th event occurred, and event-free rate at 12 months was estimated regardless of length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
    measure
    Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)
    time Frame
    Day 0 through 730 days after transplantation
secondary Outcomes
  1. description
    Event rate estimated at 12 months for time from alloHCT to first onset of moderate or severe cGVHD defined by NIH consensus criteria within 2 years after day 0. Death within 2 years after day 0 without prior moderate or severe cGVHD was considered a competing event. cGVHD was assessed and graded by an independent EAC. Each participant in the study is followed for up to 730 days after transplant. The primary analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event rate of moderate or severe cGVHD at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
    measure
    Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC
    time Frame
    Day 0 through 730 days after transplantation
  2. description
    Event-free rate estimated at 12 months for OS, which is defined as time from randomization to death from any cause. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event-free rate of OS at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
    measure
    Event-free at 12 Months for Overall Survival (OS)
    time Frame
    Up to 730 days after end of enrollment
  3. description
    Event-free rate estimated at 12 months for GRFS, which is defined as time from alloHCT to death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per Mount Sinai aGVHD International Consortium \[MAGIC\] criteria), or the first onset of moderate or severe cGVHD (graded per NIH consensus criteria), whichever is earliest, within 2 years from day 0 as assessed by independent EAC. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe cGVHD) and not based on duration of follow-up. Therefore, analysis was conducted using all available data at the time that the 56th cGFS event occurred, and event-free rate of GRFS at 12 months was estimated regardless of length of follow-up for individual participants. At time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
    measure
    Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC
    time Frame
    Day 0 through 730 days after transplantation
Full study description
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. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.
detailed Description
Cross reference NCT04013685
Source references
references
  1. citation
    Meyer EH, Salhotra A, Gandhi AP, Pantin J, Patel SS, Hoeg RT, Gomez-Arteaga A, Faramand R, Tamari R, Waller EK, Kosuri S, Jimenez Jimenez AM, Holter-Chakrabarty J, Dholaria B, Chen YB, Hamilton BK, Magenau J, Eghtedar A, Murray JM, Pavlova A, Fernhoff NB, McClellan JS, Killian MS, Li A, Negrin RS, Oliai C. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026 Mar 12;147(11):1168-1177. doi: 10.1182/blood.2025031313.
    pmid
    41385341
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        ical License Application Approvals">2026 Biological License Application Approvals</a>.</p><h2>Efficacy and Safety</h2><p>Efficacy was evaluated in Precision-T (NCT05316701), a multicenter, open-label, randomized, controlled trial in adults with acute leukemias or myelodysplastic syndrome (MDS). In total, 187 patients were randomi
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      FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies

    Preserved source evidence · Not medical advice