Acute Myeloid Leukemia Clinical Trial
— Orca-TOfficial title:
A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft
Verified date | April 2024 |
Source | Orca Biosystems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 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) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.
Status | Active, not recruiting |
Enrollment | 174 |
Est. completion date | April 2027 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System - Michigan Medicine | Ann Arbor | Michigan |
United States | Winship Cancer Institute - Emory University | Atlanta | Georgia |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Chicago | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Colorado Blood Cancer Institute | Denver | Colorado |
United States | City of Hope | Duarte | California |
United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
United States | University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Weill Cornell Medicine - New York-Presbyterian Hospital | New York | New York |
United States | OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | Oregon Health & Sciences University - Knight Cancer Institute | Portland | Oregon |
United States | UC Davis | Sacramento | California |
United States | University of Utah | Salt Lake City | Utah |
United States | Stanford Health Care | Stanford | California |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Orca Biosystems, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chronic Graft-versus-Host-Disease-free Survival | An event for this time-to-event outcome is defined as death by any cause or moderate to severe cGVHD as defined by NIH consensus criteria, whichever is earlier. | Randomization through 730 days post transplant | |
Secondary | Time to moderate or severe cGVHD | An event for this time-to-event outcome is defined as time from randomization to the first onset of of moderate or severe cGVHD within 730 days after randomization. Death within 730 days after randomization without prior moderate or severe cGVHD is considered a competing event. | Randomization through 730 days post transplant | |
Secondary | Graft-versus-Host Disease and Relapse-free survival (GRFS) up to 1 year | GRFS is defined as the time from randomization to death from any cause, relapse, the first onset of grade 3 or 4 aGVHD (graded per MAGIC criteria), or the first onset of moderate or severe cGVHD (graded per NIH consensus criteria), whichever is earliest. | Day 0 through 365 days post-transplant | |
Secondary | Overall Survival | OS is defined as the time from randomization to death from any cause . | 730 days after end of enrollment |
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