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New stem cell mix aims to make transplants safer for blood cancer patients

NCT ID NCT05316701

Disease control Sponsor: Orca Biosystems, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests a new treatment called Orca-T for people with advanced blood cancers like leukemia. Orca-T is a special mix of stem cells and immune cells from a matched donor, designed to reduce a serious side effect called graft-versus-host disease. The study compares Orca-T to the standard stem cell transplant in 187 patients, tracking how many are alive and free of moderate or severe graft-versus-host disease after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Orca-T (a mix of stem cells and immune cells from a donor)
What this could lead to
If it works, this could lead to a safer stem cell transplant with fewer severe side effects, improving survival and quality of life for people with blood cancers.
What could go wrong
This is still a phase 3 trial, so results are not yet final. The treatment may not work better than standard care, and there are risks like infection or graft failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

187 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute biphenotypic leukemia acute leukemia acute lymphoblastic leukemia acute myeloid leukemia acute undifferentiated leukemia mixed phenotype acute leukemia myelodysplastic syndrome Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma therapy-related myeloid neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute leukemia Acute lymphoid leukemia Acute myeloid leukemia Mixed phenotype acute leukemia Myelodysplastic syndrome Therapy-related myelodysplastic syndrome Undifferentiated leukemia

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, 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

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37239, United States

  • Stanford Health Care

    Stanford, California, 94305, United States

  • UC Davis

    Sacramento, California, 95817, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Michigan Health System - Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Weill Cornell Medicine - New York-Presbyterian Hospital

    New York, New York, 10021, United States

  • Winship Cancer Institute - Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.