Acute Myeloid LeukemiaPhase 1NCT04013685
Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
A Phase 1 study testing Orca-T in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Orca Biosystems, Inc. at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Orca-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 21 sitesUnited States
- Study dates
- 21 Nov 2019to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients must meet all of the following criteria:
- Patients must be diagnosed with 1 of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:
- 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)
- Acute leukemia in CR/CRi or MDS that is DRI intermediate to high risk (ages 66 to 75 years)
- BPDCN (ages 18 to 65 years)
- 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:
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- Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia that is in CR/CRi and DRI intermediate to high risk
- MDS that is DRI intermediate to high risk
- Acute or chronic leukemia in remission that is DRI low risk (ages 18 to 65 years), including the following:
- 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
- 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%
- 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
Who cannot join
- Recipients meeting any of the following exclusion criteria will not be eligible:
- 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
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- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Michigan Health System - Michigan Medicine
Ann Arbor, Michigan, 48109
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
Massachusetts
Boston, Massachusetts, 02114
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope
Duarte, California, 91010
University of Texas MD Anderson Cancer Center
Houston, Texas, 77054
The University of Kansas Hospital
Kansas City, Kansas, 66160
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt University
Nashville, Tennessee, 37232
Weill Cornell Medicine - New York-Presbyterian Hospital
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Oregon Health & Sciences University - Knight Cancer Institute
Portland, Oregon, 97239
UC Davis
Sacramento, California, 95817
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Stanford Health Care
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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
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.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia
- Being tested
- Orca-T
- Keywords
- hematopoietic stem cell transplantation, acute leukemia, Myelodysplastic syndromes, matched related donor, matched unrelated donor, TREGZI
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasm, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orca-TBiological
an allogeneic stem cell and T-cell immunotherapy biologic
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Acute Leukemia or Myelodysplastic Syndrome, or BPDCN | Experimental | This is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product. Receives: Biological: Orca-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of primary graft failure
The incidence of primary graft failure
Measured: 365 days
The incidence of grade 3 or 4 aGVHD
The incidence of grade 3 or 4 aGVHD
Measured: 180 days
Secondary outcomes (5)
1-year overall survival (OS)
1-year overall survival (OS)
Measured: 365 days
1 year graft-versus-host-disease-free and relapse-free survival (GRFS)
1 year graft-versus-host-disease-free and relapse-free survival (GRFS)
Measured: 365 days
incidence and severity of acute and chronic graft vs host disease (GvHD)
incidence and severity of acute and chronic graft vs host disease (GvHD)
Measured: 365 days
incidence of serious infections
incidence of serious infections
Measured: 365 days
incidence of engraftment
incidence of engraftment of platelets and neutrophils
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start21 Nov 2019
- Primary completion30 Apr 2025
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orca Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013685
- Sponsor's protocol ID
- Precision-T (PhIb component)
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2019
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04013685
- Acronym / sponsor ID
- Precision-T (PhIb component)
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia
- Keywords
- hematopoietic stem cell transplantation, acute leukemia, Myelodysplastic syndromes, matched related donor, matched unrelated donor, TREGZI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Orca Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Acute Leukemia or Myelodysplastic Syndrome, or BPDCN | Experimental | Biological: Orca-TThis is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must be diagnosed with 1 of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:
- 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%
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orca-Tan allogeneic stem cell and T-cell immunotherapy biologic | Biological | Subjects with Acute Leukemia or Myelodysplastic Syndrome, or BPDCN |
Primary outcome
The incidence of primary graft failure
Time frame: 365 days
The incidence of primary graft failure
The incidence of grade 3 or 4 aGVHD
Time frame: 180 days
The incidence of grade 3 or 4 aGVHD
5 secondary outcomes
1-year overall survival (OS)
Time frame: 365 days
1 year graft-versus-host-disease-free and relapse-free survival (GRFS)
Time frame: 365 days
incidence and severity of acute and chronic graft vs host disease (GvHD)
Time frame: 365 days
incidence of serious infections
Time frame: 365 days
incidence of engraftment
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Orca-T in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Orca Biosystems, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of primary graft failure (time frame: 365 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.