Myelodysplastic Syndrome Clinical Trial

A Study of Engineered Donor Grafts (Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Summary

This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Recipients must meet all of the following criteria:

Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:

acute myeloid, lymphoid or mixed phenotype leukemia that is not in CR/CRi [Ages 18-65]
myelodysplastic syndromes with > 10% to < 20% bone marrow blast burden [Ages 18-65]
acute myeloid, lymphoid or mixed phenotype leukemia that is in CR/CRi but is categorized as DRI very high risk [Ages 18-65]
Myelofibrosis [Ages 18-65]
Blastic Plasmacytoid Dendritic Cell Neoplasm [Ages 18-65]
acute myeloid, lymphoid, mixed phenotype leukemia or myelodysplastic syndromes (therapy-related/secondary MDS or eligible for alloHCT per 2017 International Expert Panel) that are in CR and intermediate to high risk per the DRI in patients aged 66 to 75 [Ages 66-75]
chronic myeloid leukemia that is in chronic phase with history of blast crisis or accelerated phase and/or is resistant to or intolerant of >1 first- or second-generation TKI [Ages 18-65]
Patients must be matched to a 8/8 HLA-matched related or unrelated donor
Estimated glomerular filtration rate (eGFR) > 50 mL/minute
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%
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:

History of 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.
Pre-planned donor lymphocyte infusion (DLI)
Planned pharmaceutical in vivo or ex vivo T cell depletion
Positive for anti-donor HLA antibodies against an allele in the selected donor
Karnofsky performance score < 70%
Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
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
Women who are pregnant or breastfeeding

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

255

Study ID:

NCT04013685

Recruitment Status:

Recruiting

Sponsor:

Orca Biosystems, Inc.

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There are 16 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Amandeep Salhotra
Contact
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States More Info
Caspian Oliai
Contact
UC Davis
Sacramento California, 95817, United States More Info
Rasmus Hoeg
Contact
Stanford Health Care
Stanford California, 94305, United States More Info
Everett Meyer
Contact
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Antonio M Jimenez, MD
Contact
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Rawan Faramand, MD
Contact
Winship Cancer Institute - Emory University
Atlanta Georgia, 30322, United States More Info
Edmund Waller
Contact
University of Chicago
Chicago Illinois, 60637, United States More Info
Satyajit Kosuri
Contact
The University of Kansas Hospital
Kansas City Kansas, 66160, United States
Weill Cornell Medicine - New York-Presbyterian Hospital
New York New York, 10021, United States More Info
Koen Van Besien
Contact
Oregon Health & Sciences University - Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Arpita Gandhi
Contact
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Jeremy Pantin
Contact
Vanderbilt University
Nashville Tennessee, 37232, United States More Info
Bhagirathbhai Dholaria
Contact
University of Texas MD Anderson Cancer Center
Houston Texas, 77054, United States
Texas Transplant Institute
San Antonio Texas, 78229, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Sagar Patel
Contact

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

255

Study ID:

NCT04013685

Recruitment Status:

Recruiting

Sponsor:


Orca Biosystems, Inc.

How clear is this clinincal trial information?

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