RecruitingPhase 2NCT06940297

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

DART: Phase II Study of Dasatinib and Quercetin in Patients With Relapsed, Refractory Multiple Myeloma Receiving CAR-T Therapy


Sponsor

Mayo Clinic

Enrollment

44 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two drugs — dasatinib and quercetin (a supplement) — to a CAR-T cell therapy called Carvykti can improve outcomes for patients with multiple myeloma (a blood cancer) that has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 or older - You have multiple myeloma that has returned or not responded to at least 3 prior treatment regimens (including specific drug types) - Carvykti (the CAR-T therapy) is already available for you - You are reasonably active and functional (ECOG score 0–2) - Your blood counts and organ function meet minimum thresholds - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have not had enough prior treatments - You have active CNS involvement with myeloma - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

BIOLOGICALCiltacabtagene Autoleucel

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

DRUGCyclophosphamide

Given IV

DRUGDasatinib

Given PO

DRUGFludarabine

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET scan

DRUGQuercetin

Given PO


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06940297


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