Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UC Davis UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Randomized Phase III Trial for 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

Details

Cross reference NCT04013685

Keywords

Acute Myeloid Leukemia Acute Lymphoid Leukemia Mixed Phenotype Acute Leukemia Undifferentiated Leukemia High-risk Myelodysplastic Syndrome Acute Leukemia Therapy-Related Myelodysplastic Syndrome hematopoietic stem cell transplantation Myelodysplastic syndromes matched related donor matched unrelated donor myelodysplastic syndrome Leukemia Preleukemia Hematologic Neoplasms Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Syndrome Acute Disease Orca-T

Eligibility

You can join if…

Open to people ages 18-65

  • 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 high to very high risk or therapy-related/secondary MDS
  • 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

You CAN'T join if...

  • 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

Locations

  • Ronald Regan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States
  • Stanford Health Care accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Orca Biosystems, Inc.
ID
NCT05316701
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 174 study participants
Last Updated