Advancing Regenerative Medicine
Stanford's Alpha Clinic supports the advancement of regenerative therapies in the following ways
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- biological: Orca-T
- biological: Standard-of-Care
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
Ages Eligible for Study
18 Years - 65 Years
Genders Eligible for Study
ALL
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kimberly Xie
Not Recruiting
The Alpha Clinic Network
We are part of a state-wide network funded by the California Institute for Regenerative Medicine
This network includes: