Myelodysplastic Syndrome Clinical Trial

Precision-T: A Study of 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:

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

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 22 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
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Alireza Eghtedar, MD
Contact
720-754-4800
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
Massachusetts
Boston Massachusetts, 02114, United States More Info
Yi-Bin Chen, MD
Contact
University of Michigan Health System - Michigan Medicine
Ann Arbor Michigan, 48109, United States More Info
Cancer Center Hotline
Contact
800-865-1125
John Magenau, MD
Principal Investigator
Weill Cornell Medicine - New York-Presbyterian Hospital
New York New York, 10021, United States More Info
Alexandra Gomez Arteaga, MD
Contact
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Roni Tamari, MD
Contact
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Betty K Hamilton, MD
Contact
216-444-7923
[email protected]
OU Health Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Jennifer Holter-Chakrabarty, MD
Contact
405-271-8299
Silas Day
Contact
(405) 271-8001
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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