UF-KURE-BCMA CAR-T Cells
A Phase 1 Single Arm, Open Label Study to Evaluate the Safety of UF-KURE-BCMA CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma
What's the purpose of the trial?
The purpose of this study is to determine if UF-KURE-BCMA (B-Cell Maturation Antigen) chimeric antigen receptor T cells (CAR-T cells) can be used to treat relapsed or treatment refractory multiple myeloma (RRMM). This treatment uses T cells already present within the body that have been modified outside of the body by a virus and then returned by an infusion to fight cancer. The investigators are evaluating UF-KURE-BCMA because it uses a manufacturing process that is shorter than other Food and Drug Administration (FDA) approved CAR-T cells and only requires a simple blood draw. The standard treatments require weeks to manufacture the cells as well a special procedure to get an individual's cells. While the shorter manufacture time can be an advantage, the safety of this approach has not been demonstrated. The use of UF-KURE-BMCA is investigational and is not approved by the FDA outside of clinical trials. This is the first study of UF-KURE-BCMA in patients.
Participants will give a pint of blood, which is the amount one would provide if they were to donate blood. The blood will be used to make the UF-KURE-BCMA cells. Participants will then receive chemotherapy followed by a one-time infusion of the experimental modified CAR-T cells. After this infusion, participants will be watched for side effects and follow up will continue for up to 15 years.
Trial status
Not yet accepting
Phase
Phase 1
Enrollment
12
Last Updated
2 months ago

Participating Centers
There is one center participating in this trial. Enter a location below to view the distance.
Experimental Treatments
Learn more about the experimental treatments being evaluated in this clinical trial.
- Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
- Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
- UF-KURE-BCMA CAR T-cells
Arms / Cohorts
Explore eligibility, treatments and learn more about potential cohorts.
Not yet accepting
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