Myelodysplastic Syndrome Clinical Trial

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

Summary

This study will compare the safety and efficacy between patients receiving an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) or standard-of-care (SOC) control in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation (MA-alloHCT) for hematologic malignancies. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.

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Full Description

Cross reference NCT04013685

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Matched to a related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and DRB1

Diagnosed with one of the following diseases:

Acute myeloid, lymphoid 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 syndromes (MDS) that are indicated for alloHSCT per 2017 International Expert Panel recommendations and/or have therapy-related/secondary MDS, with ≤ 10% blast burden in the bone marrow

Planned to undergo MA-alloHCT including one of the following myeloablative conditioning regimens:

TBI/Cy
TBI/Etoposide
BFT
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%
Negative serum or urine beta-HCG test in females of childbearing potential
ALT/AST < 3 times ULN
Recipients in screening must screen negative for SARS-CoV-2 RNA using a PCR-based test
Disease Risk Index (DRI) overall risk categorization of intermediate or high
Total bilirubin ≤ upper limit of normal (ULN)
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute

Key Exclusion Criteria:

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.
Planned donor lymphocyte infusion (DLI)
Planned pharmaceutical in vivo or ex vivo T cell depletion
Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor
Karnofsky performance score < 70%
Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
Uncontrolled bacterial, viral or fungal infections at time of enrollment
Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, Hepatitis C antibody
Known allergy or hypersensitivity to, or intolerance of, tacrolimus
Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins
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
Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow up care
Women who are pregnant or breastfeeding
Women of childbearing potential (WOCBP) or men who have sexual contact with WOCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

174

Study ID:

NCT05316701

Recruitment Status:

Recruiting

Sponsor:

Orca Biosystems, Inc.

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There are 13 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Amandeep Salhotra
Contact
Ronald Regan UCLA Medical Center
Los Angeles California, 90095, United States More Info
Caspian Oliai, MD
Contact
Bruck Habtemariam
Contact
[email protected]
UC Davis
Sacramento California, 95817, United States More Info
Rasmus Hoeg
Contact
Dara Feleciano, RN MSN
Contact
[email protected]
Stanford Health Care
Stanford California, 94305, United States More Info
Everett Meyer, MD, PhD
Contact
Lindsay Danley
Contact
[email protected]
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
888-663-3488
[email protected]
Winship Cancer Institute - Emory University
Atlanta Georgia, 30322, United States More Info
Edmund Waller, MD, PhD
Contact
University of Chicago
Chicago Illinois, 60637, United States More Info
Satyajit Kosuri, MD
Contact
Weill Cornell Medicine - New York-Presbyterian Hospital
New York New York, 10021, United States More Info
Koen Van Besien, MD, PhD
Contact
Meredith Mullane, RN
Contact
212-746-0702
[email protected]
Oregon Health & Sciences University - Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Arpita Gandhi, MD
Contact
Vanderbilt University
Nashville Tennessee, 37232, United States More Info
Bhagirathbhai Dholaria, MD
Contact
615-343-6653
Rohan Goel
Contact
[email protected]
Sarah Cannon Research Institute
Nashville Tennessee, 37239, United States More Info
Jeremy Pantin, MD
Contact
615-342-3385
University of Utah
Salt Lake City Utah, 84112, United States More Info
Sagar Patel, MD
Contact
Collind Boyington
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

174

Study ID:

NCT05316701

Recruitment Status:

Recruiting

Sponsor:


Orca Biosystems, Inc.

How clear is this clinincal trial information?

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