Status:
ACTIVE_NOT_RECRUITING
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Lead Sponsor:
Orca Biosystems, Inc.
Conditions:
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 mobil...
Detailed Description
Cross reference NCT04013685
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT05316701
Start Date
June 21 2022
End Date
July 1 2026
Last Update
September 26 2025
Active Locations (19)
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1
City of Hope
Duarte, California, United States, 91010
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
3
UC Davis
Sacramento, California, United States, 95817
4
Stanford Health Care
Stanford, California, United States, 94305