Study on Orca-T for Patients Undergoing Stem Cell Transplant for Blood Cancers
Sponsor: Orca Biosystems, Inc.
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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| Ronald Reagan UCLA Medical Center | 90095 | Los Angeles | California |
| UC Davis | 95817 | Sacramento | California |
| Stanford Health Care | 94305 | Stanford | California |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Winship Cancer Institute - Emory University | 30322 | Atlanta | Georgia |
| University of Chicago | 60637 | Chicago | Illinois |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
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