NCT06698744

UF-KURE-BCMA CAR-T Cells in Patients With Relapsed or Refractory Multiple Myeloma

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: David Wald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

UF-KURE-BCMA is an autologous CAR-T cell therapy consisting of autologous cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using a novel ultrafast lentiviral manufacturing system to express a humanized BCMA CAR-T that targets the BCMA receptor to eliminate multiple myeloma cells using simple peripheral blood draws instead of invasive leukapheresis. This ultrafast platform optimizes CAR-T potency and allows for quicker and cheaper manufacturing of these agents. The goal of this phase 1 study is to find recommended phase 2 dose of UF-KURE-BCMA for treatment of patients with relapsed or refractory multiple myeloma

Conditions

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
BIOLOGICAL	UF-KURE-BCMA CAR T-cells	Experimental anti-BCMA CAR T-cells manufactured with a proprietary ultrafast process. Patients will receive a single dose of CAR T-cells at one of three potential doses: * Dose -1: 3x10\^6 cells * Dose 1: 10x10\^6 cells * Dose 2: 15x10\^6 cells
DRUG	Cyclophosphamide	Patients will receive 3 days of intravenous (IV) cyclophosphamide 500 mg/m\^2 days -5 to -3 or -4 to -2 where day 0 is the day of CAR T-cell infusion.
DRUG	Fludarabine	Patients will receive 3 days of IV fludarabine 30 mg/m2 days -5 to -3 or -4 to -2 where day 0 is the day of CAR T-cell infusion.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-11
• Completion: 2028-09-01
• First posted: 2024-11-21
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study