Leukemia, Myeloid, AcutePhase 2NCT07216443
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 2 study testing Orca-T in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Orca Biosystems, Inc. at 6 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia
- What is being tested?
- Orca-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Dec 2025to Dec 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of enrollment
- Diagnosed with 1 of the following diseases:
- Acute myeloid, 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 syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and/or therapy-related/secondary MDS as defined by the World Health Organization (WHO) classification of myeloid malignancies, with ≤10% blast burden in the bone marrow.
- Planned to undergo 1 of the following preparative regimens as per Investigator discretion:
- RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI/thiotepa/fludarabine
Show all 15Show fewer
- NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine/cyclophosphamide/TBI
- Identified related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and -DRB1
- Estimated glomerular filtration rate ≥30 mL/minute
- Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA)
- Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%
- Negative serum or urine β-HCG test in persons of childbearing potential
- Alanine transaminase (ALT)/aspartate transaminase (AST) <5 times the upper limit of normal (ULN)
- Total bilirubin <3 × ULN
- Deemed ineligible for a fully myeloablative alloHCT per assessment of the principal investigator
Who cannot join
- Prior alloHCT
- 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 antidonor HLA antibodies against a mismatched allele in the selected donor
- Karnofsky performance score <60%
Show all 17Show fewer
- For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6
- Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment
- Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or HCV antibody unless previously treated with curative therapy and are HCV NAT negative
- 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 malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected
- Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care
- Persons who are pregnant or breastfeeding
- Person of childbearing potential (POCBP) or men who have sexual contact with POCBP who are unwilling to use effective forms of birth control or abstinence for 1 year after transplantation.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the recipient's safe participation in and completion of the trial or which could affect compliance with the protocol or interpretation of results
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Siddhartha Reddy, 551-996-5900, siddhartha.reddy@hmhn.org
- Recruiting
UCLA Department of Medicine
Los Angeles, California, 90095
Caspian Oliai, 310-794-0824, coliai@mednet.ucla.edu
- Recruiting
Vanderbilt University, Ingram Cancer Center
Nashville, Tennessee, 37232
Bhagirathbhai Dholaria, 615-875-3112, Bhagirathbhai.r.dholaria@vumc.org
- Recruiting
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, 10065
Alexandra Gomez Arteaga, MD, 646-962-7950, alg9117@med.cornell.du
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Arpita Gandhi, 503-494-5058, gandhiar@ohsu.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Nelli Bejanyan, MD, (813) 745-6008, nelli.bejanyan@moffitt.org
About this study
Official title: A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is 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).
Read the detailed description
This study is a multicenter, open-label phase 2 trial of Orca-T in adults with acute myeloid leukemia or myelodysplastic syndrome who are not able to receive myeloablative (high intensity) conditioning and are eligible for reduced intensity conditioning (RIC)-alloHCT or non-myeloablative (NMA)-alloHCT with an 8/8 human leukocyte antigen (HLA)-matched related or unrelated donor. The trial is designed to further characterize the safety and tolerability of Orca-T and to perform an initial assessment of the efficacy of Orca-T in participants eligible for RIC-alloHCT or NMA-alloHCT.
Participants will receive Orca-T after the investigator's choice from the RIC and NMA regimens followed by single-agent graft-versus-host disease (GVHD) prophylaxis with tacrolimus.
Prior to the initiation of this study (the SERENE-T Study), a phase 1 study (clinicaltrials.gov number: NCT05088356) was conducted to examine the safety and efficacy of Orca-T in participants receiving RIC-alloHCT. Participants have also been treated previously with Orca-T during an ongoing phase 1b/3 study (NCT05316701 and NCT04013685) in participants receiving a MAC regimen. The results of these studies have prompted Orca Bio to further evaluate Orca-T in participants receiving RIC or NMA.
- Being tested
- Orca-T
- Keywords
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Therapy-Related Myelodysplastic Syndrome, Hematopoietic Stem Cell Transplantation, Humans, Graft vs Host Disease, SERENE-T, ORCA-T, Disease, Pathologic Processes, Neoplasms by Histologic Type, Neoplasms, Hematologic Diseases, Bone Marrow Diseases, Precancerous Conditions, Neoplasms by Site, Disease Attributes, Immunoproliferative Disorders, Immune System Diseases
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Biphenotypic, Acute, Graft vs Host Disease, Disease, Pathologic Processes, Neoplasms by Histologic Type, Neoplasms
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 |
|---|---|---|
| Orca-T | Experimental | Participants will receive [RIC or NMA conditioning] + Orca-T + single-agent tacrolimus based on eligibility and investigator's choice of conditioning regimen. Receives: Biological: Orca-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
RIC Cohort: GVHD-free and relapse-free survival (GRFS)
GRFS is defined as the time from the date of transplantation to the date of death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per MAGIC criteria), or the first onset of moderate or severe chronic GVHD (graded per NIH consensus criteria), whichever is earliest.
Measured: Day 0 through day +365 after transplantation
NMA Cohort: Incidence of neutrophil engraftment
Incidence of neutrophil engraftment is defined as achieving an ANC ≥500/mm3 for 3 consecutive days by day +28. The first of the 3 days will be designated the day of engraftment. If the ANC never drops below 500/mm3, day +1 will be designated the day of engraftment.
Measured: Day 0 through day +28 after transplantation
NMA Cohort: Time to neutrophil engraftment
The first of the 3 days will be designated the day of engraftment. If the ANC never drops below 500/mm3, day +1 will be designated the day of engraftment.
Measured: Day 0 through day +28 after transplantation
Secondary outcomes (20)
Safety of Orca-T
The incidence of graft failure, grade ≥3 acute GVHD (per MAGIC criteria), grade ≥4 infection (per CTCAE v5.0), manufacturing failure, and non-relapse mortality for each cohort.
Measured: Day 0 through day +100 after transplantation
Incidence of serious infections
The incidence of grade ≥3 infection (per CTCAE v5.0)
Measured: Day 0 through day +365 after transplantation
Severity of serious infection
The severity of grade ≥3 infection (per CTCAE v5.0)
Measured: Day 0 through day +365 after transplantation
Overall survival
The rate of overall survival for each cohort.
Measured: Day 0 through day +730 after transplantation
Non-relapse mortality
The rate of non-relapse mortality for each cohort
Measured: Day 0 through day +730 after transplantation
Relapse-free survival
The rate of relapse-free survival for each cohort.
Measured: Day 0 through day +730 after transplantation
Chronic GVHD-free survival
The rate of chronic GVHD-free survival for each cohort
Measured: Day 0 through day +730 after transplantation
GVHD-free and relapse-free survival (GRFS)
The rate of GRFS for the NMA cohort.
Measured: Day 0 through day +730 after transplantation
Incidence of acute GVHD
The incidence of acute GVHD (all grades) for each cohort
Measured: Day 0 through day +180 after transplantation
Severity of acute GVHD
The severity of acute GVHD (all grades) for each cohort
Measured: Day 0 through day +180 after transplantation
Time to onset of acute GVHD
Time to first onset of grade 2 through 4 acute GVHD
Measured: Day 0 through day +180 after transplantation
Incidence of chronic GVHD
The incidence of chronic GVHD (all grades)
Measured: Day 0 through day +730 after transplantation
Severity of chronic GVHD
The severity of chronic GVHD (all grades)
Measured: Day 0 through day +730 after transplantation
Time to onset of acute GVHD
Time to first onset of moderate or severe chronic GVHD
Measured: Day 0 through day +730 after transplantation
RIC cohort: Incidence of neutrophil engraftment
The incidence of neutrophil engraftment in the RIC cohort.
Measured: Day 0 through day +28 after transplantation
RIC cohort: Time to neutrophil engraftment
Time to neutrophil engraftment in the RIC cohort.
Measured: Day 0 through day +28 after transplantation
Incidence of platelet engraftment
The incidence of platelet engraftment.
Measured: Day 0 through day +50 after transplantation
Time to platelet engraftment
Time to platelet engraftment.
Measured: Day 0 through day +50 after transplantation
Incidence of steroid-refractory acute GVHD
The incidence of steroid-refractory acute GVHD for each cohort.
Measured: Day 0 through day +180 after transplantation
Incidence of steroid-refractory chronic GVHD
The incidence of steroid-refractory chronic GVHD for each cohort.
Measured: Day 0 through day +730 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start9 Dec 2025
- Primary completionNov 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a multicenter, open-label phase 2 trial of Orca-T in adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are eligible for RIC-alloHCT or NMA-alloHCT with an 8/8 HLA-matched related or unrelated donor. Participants will receive Orca-T after the investigator's choice from the RIC and NMA regimens allowed as per protocol. Single-agent GVHD prophylaxis with tacrolimus will be administered.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orca Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216443
- Sponsor's protocol ID
- SERENE-T
- Status last verified
- Jul 2026
- First submitted
- 29 Sep 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT07216443
- Acronym / sponsor ID
- SERENE-T
- Keywords
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Therapy-Related Myelodysplastic Syndrome, Hematopoietic Stem Cell Transplantation, Humans, Graft vs Host Disease, SERENE-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Orca Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Oct 2025 (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 in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is 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).
Detailed description
This study is a multicenter, open-label phase 2 trial of Orca-T in adults with acute myeloid leukemia or myelodysplastic syndrome who are not able to receive myeloablative (high intensity) conditioning and are eligible for reduced intensity conditioning (RIC)-alloHCT or non-myeloablative (NMA)-alloHCT with an 8/8 human leukocyte antigen (HLA)-matched related or unrelated donor. The trial is designed to further characterize the safety and tolerability of Orca-T and to perform an initial assessment of the efficacy of Orca-T in participants eligible for RIC-alloHCT or NMA-alloHCT.
Participants will receive Orca-T after the investigator's choice from the RIC and NMA regimens followed by single-agent graft-versus-host disease (GVHD) prophylaxis with tacrolimus.
Prior to the initiation of this study (the SERENE-T Study), a phase 1 study (clinicaltrials.gov number: NCT05088356) was conducted to examine the safety and efficacy of Orca-T in participants receiving RIC-alloHCT. Participants have also been treated previously with Orca-T during an ongoing phase 1b/3 study (NCT05316701 and NCT04013685) in participants receiving a MAC regimen. The results of these studies have prompted Orca Bio to further evaluate Orca-T in participants receiving RIC or NMA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicenter, open-label phase 2 trial of Orca-T in adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are eligible for RIC-alloHCT or NMA-alloHCT with an 8/8 HLA-matched related or unrelated donor. Participants will receive Orca-T after the investigator's choice from the RIC and NMA regimens allowed as per protocol. Single-agent GVHD prophylaxis with tacrolimus will be administered.
| Arm | Type | Receives |
|---|---|---|
| Orca-T | Experimental | Biological: Orca-TParticipants will receive [RIC or NMA conditioning] + Orca-T + single-agent tacrolimus based on eligibility and investigator's choice of conditioning regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years at the time of enrollment
- Diagnosed with 1 of the following diseases:
- Planned to undergo 1 of the following preparative regimens as per Investigator discretion:
- Identified related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and -DRB1
- Estimated glomerular filtration rate ≥30 mL/minute
Key exclusion criteria (17 listed)
- Prior alloHCT
- 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 antidonor HLA antibodies against a mismatched 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 | Orca-T |
Primary outcome
RIC Cohort: GVHD-free and relapse-free survival (GRFS)
Time frame: Day 0 through day +365 after transplantation
GRFS is defined as the time from the date of transplantation to the date of death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per MAGIC criteria), or the first onset of moderate or severe chronic GVHD (graded per NIH consensus criteria), whichever is earliest.
NMA Cohort: Incidence of neutrophil engraftment
Time frame: Day 0 through day +28 after transplantation
Incidence of neutrophil engraftment is defined as achieving an ANC ≥500/mm3 for 3 consecutive days by day +28. The first of the 3 days will be designated the day of engraftment. If the ANC never drops below 500/mm3, day +1 will be designated the day of engraftment.
NMA Cohort: Time to neutrophil engraftment
Time frame: Day 0 through day +28 after transplantation
The first of the 3 days will be designated the day of engraftment. If the ANC never drops below 500/mm3, day +1 will be designated the day of engraftment.
20 secondary outcomes
Safety of Orca-T
Time frame: Day 0 through day +100 after transplantation
Incidence of serious infections
Time frame: Day 0 through day +365 after transplantation
Severity of serious infection
Time frame: Day 0 through day +365 after transplantation
Overall survival
Time frame: Day 0 through day +730 after transplantation
Non-relapse mortality
Time frame: Day 0 through day +730 after transplantation
Relapse-free survival
Time frame: Day 0 through day +730 after transplantation
Chronic GVHD-free survival
Time frame: Day 0 through day +730 after transplantation
GVHD-free and relapse-free survival (GRFS)
Time frame: Day 0 through day +730 after transplantation
Incidence of acute GVHD
Time frame: Day 0 through day +180 after transplantation
Severity of acute GVHD
Time frame: Day 0 through day +180 after transplantation
Time to onset of acute GVHD
Time frame: Day 0 through day +180 after transplantation
Incidence of chronic GVHD
Time frame: Day 0 through day +730 after transplantation
Severity of chronic GVHD
Time frame: Day 0 through day +730 after transplantation
Time to onset of acute GVHD
Time frame: Day 0 through day +730 after transplantation
RIC cohort: Incidence of neutrophil engraftment
Time frame: Day 0 through day +28 after transplantation
RIC cohort: Time to neutrophil engraftment
Time frame: Day 0 through day +28 after transplantation
Incidence of platelet engraftment
Time frame: Day 0 through day +50 after transplantation
Time to platelet engraftment
Time frame: Day 0 through day +50 after transplantation
Incidence of steroid-refractory acute GVHD
Time frame: Day 0 through day +180 after transplantation
Incidence of steroid-refractory chronic GVHD
Time frame: Day 0 through day +730 post-transplant
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orca-T in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Orca Biosystems, Inc. at 6 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 15 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Chief Medical Officer (650-246-9601, info@orcabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RIC Cohort: GVHD-free and relapse-free survival (GRFS) (time frame: Day 0 through day +365 after transplantation). The study lists 3 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 7 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.