A Phase 2 Trial in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Undergoing Reduced Intensity or Non-myeloablative Allogeneic Hematopoietic Cell Transplantation With Orca-T

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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. 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 1: Planned RIC-alloHCT including RIC regimen with TBI/thiotepa/fludarabine

‣ NMA cohort 2: Planned NMA-alloHCT including NMA regimen with fludarabine/cyclophosphamide/TBI

• Identified sibling 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 women 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

Locations
United States
California
UCLA Department of Medicine
RECRUITING
Los Angeles
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
NOT_YET_RECRUITING
Hackensack
Oregon
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Contact Information
Primary
Chief Medical Officer
info@orcabio.com
650-246-9601
Backup
Medical Director
info@orcabio.com
650-246-9601
Time Frame
Start Date: 2025-11
Estimated Completion Date: 2028-12
Participants
Target number of participants: 80
Treatments
Experimental: Orca-T
Participants will receive \[RIC or NMA conditioning\] + Orca-T + single-agent tacrolimus based on eligibility and investigator's choice of conditioning regimen.
Sponsors
Leads: Orca Biosystems, Inc.

This content was sourced from clinicaltrials.gov

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