Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Summary

This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide and fludarabine are given to help kill any remaining cancer cells in the body and to prepare the bone marrow for CAR-T therapy. Chimeric antigen receptor T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory multiple myeloma.

Conditions

• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

BIOLOGICAL

Ciltacabtagene Autoleucel

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Dasatinib

Given PO

DRUG

Fludarabine

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

DRUG

Quercetin

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Yi Lin, MD, PhD · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-23

Primary Completion

2031-08-15

Completion

2031-08-15

FDA Drug

Yes

Countries

• United States

Study Locations