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Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

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

NCT04013685•Orca Biosystems, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Recipients must meet all of the following criteria:
•1. Patients must diagnosed with one 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
+6 more criteria

Exclusion Criteria

•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
+2 more criteria

Locations (21)

City of Hope

Duarte, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

Stanford Health Care

Stanford, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute - Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

The University of Kansas Hospital

Kansas City, Kansas, United States

Key Dates

Start Date

November 21, 2019

Primary Completion Date

April 30, 2025

Completion Date

April 1, 2027

Last Updated

May 2, 2025

Enrollment

255

ESTIMATED participants

Conditions

Acute Myeloid LeukemiaAcute Lymphoid LeukemiaMyelodysplastic SyndromesAcute LeukemiaBlastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Chronic Myeloid Leukemia

Interventions

Orca-T

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

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A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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