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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05316701
Other study ID # Precision-T (PhIII component)
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 21, 2022
Est. completion date April 2027

Study information

Verified date April 2024
Source Orca Biosystems, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Description:

Cross reference NCT04013685


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
Orca-T
an allogeneic stem cell and T-cell immunotherapy biologic
Standard-of-Care
unmanipulated donor allograft

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Orca Biosystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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