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UF-KURE-BCMA CAR-T Cells in Patients With Relapsed or Refractory Multiple Myeloma | Clinical Trials | Clareo Health

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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

NCT06698744•David Wald

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female participants aged 18 years or older.
•Subjects must have Multiple Myeloma that is relapsed (defined as non-responsive or progressive disease while on therapy or within 60 days of last treatment in participants who had achieved a minimal response (MR) or better on prior therapy) after three or more lines of therapy including at least one proteasome inhibitor, one imide, and one anti-CD38 agent.
•Participants with multiple myeloma with comorbid amyloid and/or extramedullary disease will be eligible.
•To be eligible for response assessment, participants must have measurable disease at the time of screening defined as serum protein electrophoresis M-spike greater than or equal to 0.5 g/dl, urine protein electrophoresis M spike greater than or equal to 200 mg/24 hr, or difference in involved free light chain level of greater than or equal to 10 mg/dl provided serum free light chain (FLC) ratio is abnormal.
•ECOG Performance status ≤ 2
•Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of blood sample collection for CAR-T manufacturing unless treatment was investigational, in which case a minimum of 4 weeks since last treatment is required. Prior CAR-T therapy is acceptable if participants exhibited progression free survival of greater than 6 months post CAR-T infusion.
•Total bilirubin ≤ 2X institutional upper limit of normal (except in participants with Gilbert's syndrome).
•AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal.
•Calculated creatinine clearance ≥ 30mL/min estimated by the Cockcroft - Gault formula.
•Cardiac ejection fraction of ≥45% as determined by an echocardiogram.
+4 more criteria

Exclusion Criteria

•Autologous stem cell transplant within 6 weeks of informed consent.
•Active CNS involvement of multiple myeloma.
•Plasma cell leukemia
•History of allogeneic hematopoietic stem cell transplantation.
•Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Stage 1 uterine cancer or localized prostate cancer.
•New York Heart Association class IV congestive heart failure.
•Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.
•Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness.
•Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
•Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on the most recent bone marrow biopsy prior to initiation of therapy.
+4 more criteria

Locations (1)

University Hospitals Cleveland Medical Center Seidman Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

September 1, 2025

Primary Completion Date

December 11, 2026

Completion Date

September 1, 2028

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple MyelomaMultiple Myeloma in RelapseMultiple Myeloma, Refractory

Interventions

UF-KURE-BCMA CAR T-cells

BIOLOGICAL

Cyclophosphamide

DRUG

Fludarabine

DRUG

Contacts

James Ignatz-Hoover, MD, PhD

CONTACT

216-844-0139 James.Ignatz-Hoover.2@uhhospitals.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

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