Is NCT07216443 recruiting in Tampa, FL?

Yes, NCT07216443 is currently recruiting participants at its Tampa, FL location. This leukemia, myeloid, acute clinical trial is actively enrolling qualified participants.

How do I join the leukemia, myeloid, acute clinical trial in Tampa?

To join this clinical trial in Tampa, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tampa clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Leukemia, Myeloid, Acute Clinical Trial in Tampa, FL

About This Leukemia, Myeloid, Acute Study in Tampa

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. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).

Sponsor: Orca Biosystems, Inc.

Who Can Participate

Inclusion 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 myeloid malignancies, with ≤10% blast burden in the bone marrow.

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

Exclusion Criteria

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 could affect compliance with the protocol or interpretation of results

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tampa?

Yes, this clinical trial (NCT07216443) has an active research site in Tampa, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Leukemia, Myeloid, Acute Treatment Options in Tampa, FL

If you're searching for leukemia, myeloid, acute treatment options in Tampa, FL, this clinical trial (NCT07216443) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tampa research site is actively enrolling participants for this clinical trial. You'll receive care from experienced leukemia, myeloid, acute specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all leukemia, myeloid, acute clinical trials near you to find additional studies recruiting in your area.

Leukemia, Myeloid, Acute Clinical Trial in Tampa, FL

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