Study on Orca-T for Patients Undergoing Stem Cell Transplant for Blood Cancers

Sponsor: Orca Biosystems, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05316701

This clinical trial is testing the safety and effectiveness of Orca-T, a new type of stem cell and T-cell therapy, for patients receiving a stem cell transplant to treat blood cancers. The therapy is made from a donor's blood and includes special cells to help the transplant work better.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new treatment called Orca-T, which is used in patients undergoing a stem cell transplant for blood cancers. Orca-T is made from a donor's blood and includes different types of cells that help the transplant process. This study is part of a larger research project called Precision-T, focusing on how well this treatment works and how safe it is for patients.

Description

This study is part of a larger research project called Precision-T, which is exploring the use of Orca-T in patients undergoing stem cell transplants for blood cancers. Orca-T is a special treatment made from a donor's blood, containing stem cells and two types of T-cells that help the transplant process. The study aims to determine if this treatment is safe and effective for patients.

Eligibility Criteria

Inclusion Criteria

  • Must have a donor who is a perfect match for specific genetic markers.
  • Diagnosed with certain blood cancers, such as acute leukemia or myelodysplastic syndromes, and in remission or with minimal disease.
  • Planned to receive a specific type of high-dose chemotherapy before the transplant.
  • Heart function must be adequate, with specific measurements.
  • Lung function must be adequate, with specific measurements.
  • Women of childbearing potential must have a negative pregnancy test.
  • Liver function tests must be within normal limits.
  • Must test negative for COVID-19.
  • Must have a certain level of kidney function.
  • Must have an intermediate or high risk of disease progression.

Exclusion Criteria

  • Have had a previous stem cell transplant.
  • Currently taking certain medications that suppress the immune system, except for low-dose steroids.
  • Planned to receive additional donor cells or treatments that remove T-cells.
  • Have antibodies against the donor's cells.
  • Have a low performance score indicating poor health.
  • Have a high score on a specific index measuring other health conditions.
  • Have uncontrolled infections at the time of enrollment.
  • Test positive for certain viruses, including HIV and hepatitis.
  • Have allergies to specific medications or proteins.
  • Have uncontrolled autoimmune diseases requiring treatment.
  • Have other active cancers or diseases within the past year, except for certain skin cancers.
  • Have social or psychological issues that prevent participation in the study.
  • Women who are pregnant or breastfeeding.
  • Women and men who are not willing to use birth control or abstain from sex for one year after the transplant.

Locations

FACILITYZIPCITYSTATE
City of Hope91010DuarteCalifornia
Ronald Reagan UCLA Medical Center90095Los AngelesCalifornia
UC Davis95817SacramentoCalifornia
Stanford Health Care94305StanfordCalifornia
Colorado Blood Cancer Institute80218DenverColorado
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center33136MiamiFlorida
Moffitt Cancer Center33612TampaFlorida
Winship Cancer Institute - Emory University30322AtlantaGeorgia
University of Chicago60637ChicagoIllinois
Massachusetts General Hospital02114BostonMassachusetts

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