CAR T-cell Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen by Koen van Besien, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: David Wald

No Placebo Group

Trial Summary

What is the purpose of this 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.

Research Team

Koen van Besien, MD, PhD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with relapsed or treatment-resistant multiple myeloma. Participants must be able to provide a pint of blood and undergo chemotherapy before receiving the experimental CAR-T cell therapy. Specific inclusion and exclusion criteria details are not provided, but typically involve health status and prior treatments.

Inclusion Criteria

It has been at least 2 weeks since my last cancer treatment before giving blood for CAR-T therapy.

Total bilirubin ≤ 1.52X institutional upper limit of normal

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

My multiple myeloma has spread to my brain.

My tests show early signs of a bone marrow disorder.

I have severe heart failure.

Treatment Details

Interventions

• UF-KURE-BCMA CAR-T Cells (CAR T-cell Therapy)

Trial Overview The study tests UF-KURE-BCMA CAR-T cells, which are modified T cells designed to target cancer in patients with multiple myeloma. The process involves taking a patient's blood, modifying the T cells outside the body, then infusing them back into the patient after chemotherapy.

Participant Groups

Group I: UF-KURE-BCMA T cell-based immunotherapy Experimental Treatment 3 Interventions

Pre-infusion will include multiple myeloma testing, preCAR-T evaluation, and cells will be collected. Participants will undergo lymphodepletion and inpatient CAR T-cell infusion. Patients will be monitored closely during a 28 day dose limiting toxicity (DLT) period.

Who Is Running the Clinical Trial?

David Wald

Lead Sponsor

Trials

3

Recruited

40+