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

NCT06698744 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • David Wald

    lead OTHER

Principal Investigators

  • James Ignatz-Hoover, MD, PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-12-11
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698744 on ClinicalTrials.gov