BridgeMD
New treatment option for Leukemia, Myeloid, Acute
Official title Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT07216443
What this study is testing
What is Orca-T?
Orca-T is an investigational medicine, being studied as a potential treatment for leukemia, myeloid, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years at the time of enrollment
- Diagnosed with 1 of the following diseases:
- Acute myeloid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence...
- Myelodysplastic syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and/or therapy-related/secondary MDS...
- Planned to undergo 1 of the following preparative regimens as per Investigator discretion:
You likely can't join if
- Prior alloHCT
- Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or...
- Planned donor lymphocyte infusion (DLI)
- Planned pharmaceutical in vivo or ex vivo T-cell depletion
- Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor
- Karnofsky performance score \<60%
See the full eligibility criteria
- Age ≥18 years at the time of enrollment
- Diagnosed with 1 of the following diseases:
- Acute myeloid, 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 syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and/or therapy-related/secondary MDS as defined by the World Health Organization (WHO) classification of...
- Planned to undergo 1 of the following preparative regimens as per Investigator discretion:
- RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI/thiotepa/fludarabine
- NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine/cyclophosphamide/TBI
- Identified related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and -DRB1
- Estimated glomerular filtration rate ≥30 mL/minute
- Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA)
- Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%
- Negative serum or urine β-HCG test in persons of childbearing potential
- Alanine transaminase (ALT)/aspartate transaminase (AST) \<5 times the upper limit of normal (ULN)
- Total bilirubin \<3 × ULN
- Deemed ineligible for a fully myeloablative alloHCT per assessment of the principal investigator
- Prior alloHCT
- 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 antidonor HLA antibodies against a mismatched allele in the selected donor
- Karnofsky performance score \<60%
- For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6
- Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment
- Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or HCV antibody unless previously treated with curative therapy and are HCV NAT negative
- 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 malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected
- Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care
- Persons who are pregnant or breastfeeding
- Person of childbearing potential (POCBP) or men who have sexual contact with POCBP who are unwilling to use effective forms of birth control or abstinence for 1 year after transplantation.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the recipient's safe participation in and completion of the trial or which...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Tampa, Florida, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Tampa, Florida, United States; Hackensack, New Jersey, United States; New York, New York, United States; Portland, Oregon, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.