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New stem cell therapy aims to tame transplant complications

NCT ID NCT04013685

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 1 time

Summary

This study tests a new treatment called Orca-T for people with advanced blood cancers like leukemia. It uses a special mix of stem cells and immune cells from a donor to help the body accept the transplant while reducing serious side effects like graft-versus-host disease. The goal is to improve survival and quality of life after a stem cell transplant.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

155 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Apr 2027

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 75 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: Recipients must meet all of the following criteria: 1. Patients must be diagnosed with 1 of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned: A) 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) B) Acute leukemia in CR/CRi or MDS that is DRI intermediate to high risk (ages 66 to 75 years) C) BPDCN (ages 18 to 65 years) D) 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: i. Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia that is in CR/CRi and DRI intermediate to high risk a) MDS that is DRI intermediate to high risk E) Acute or chronic leukemia in remission that is DRI low risk (ages 18 to 65 years), including the following: i. 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 ii. Acute myeloid leukemia (AML) with inv(16) without accompanying complex cytogenetics 2. Patients must be matched to a 8/8 HLA-matched related or unrelated donor 3. Estimated glomerular filtration rate (eGFR) \>50 mL/minute 4. Cardiac ejection fraction at rest ≥45% or shortening fraction of ≥27% by echocardiogram or radionuclide scan (MUGA) 5. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥50% 6. 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 Key Exclusion Criteria: Recipients meeting any of the following exclusion criteria will not be eligible: 1. History of prior allogeneic HCT 2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. 3. Pre-planned donor lymphocyte infusion (DLI) 4. Planned pharmaceutical in vivo or ex vivo T cell depletion 5. Positive for anti-donor HLA antibodies against an allele in the selected donor 6. Karnofsky performance score \<70% 7. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \>4 8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment 9. Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody 10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment 11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected 12. Women who are pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

acute leukemia acute lymphoblastic leukemia acute myeloid leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm CD4+/CD56+ hematodermic neoplasm chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive mixed phenotype acute leukemia myelodysplastic syndrome Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma

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 Blastic plasmacytoid dendritic cell neoplasm (BPDCN) Chronic myeloid leukemia Myelodysplastic syndromes

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

    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, 37203, United States

  • Stanford Health Care

    Stanford, California, 94305, United States

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160, 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 Texas MD Anderson Cancer Center

    Houston, Texas, 77054, United States

  • University of Utah - Huntsman Cancer Institute

    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.