Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06940297

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

Led by Mayo Clinic · Updated on 2026-02-06

44

Participants Needed

1

Research Sites

320 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Relapsed or refractory multiple myeloma with at least 3 prior therapies including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody
  • Availability of ciltacabtagene autoleucel (Carvykti) for treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • Hemoglobin level of 8.0 g/dL or higher within 14 days prior to registration
  • Absolute neutrophil count of 1,000/mm3 or higher within 14 days prior to registration
  • Platelet count of 50,000/mm3 or higher within 14 days prior to registration
  • Total bilirubin level less than or equal to 1.5 times the upper limit of normal within 14 days prior to registration (up to 3 times ULN for patients with Gilbert's syndrome)
  • ALT and AST levels less than or equal to 2 times the upper limit of normal within 14 days prior to registration
  • Alkaline phosphatase level less than or equal to 1.5 times the upper limit of normal within 14 days prior to registration
  • Calculated creatinine clearance of 30 ml/min or higher within 14 days prior to registration
  • Negative pregnancy test within 7 days prior to registration for persons of childbearing potential
  • Use of effective contraception with low failure rate during study and for at least 30 days after last study drug dose for sexually active patients and partners
  • Written informed consent provided
  • Willingness to provide mandatory blood and bone marrow specimens for research
  • Willingness to provide mandatory bone marrow cores and/or tissue specimens for research
  • Willingness to return to enrolling institution for follow-up during active monitoring phase
Not Eligible

You will not qualify if you...

  • Diagnosis of monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis
  • Failure to recover from acute, reversible effects of prior therapy, except stable Grade 1 peripheral sensory neuropathy for at least 1 month
  • Pregnant or nursing persons
  • Persons of childbearing potential or able to father a child who do not use adequate contraception
  • Major surgery within 28 days prior to registration
  • Severe concurrent illnesses or systemic diseases that interfere with study participation or safety assessment
  • Immunocompromised patients or known HIV positive patients (except those with well-controlled HIV on antiretroviral therapy)
  • Evidence of significant cardiovascular disease including uncontrolled arrhythmias, recent myocardial infarction or coronary procedures, severe heart failure, uncontrolled hypertension, life-threatening ventricular arrhythmias, or prolonged QTc interval
  • Uncontrolled infections or illnesses
  • Receiving other investigational agents for primary cancer
  • Live vaccine within 6 weeks prior to registration
  • Use of strong CYP3A4/5 inhibitors or inducers within 14 days prior to registration (except short courses with dose adjustment)
  • Known allergy to dasatinib or quercetin
  • Use of therapeutic anticoagulants or full-dose antiplatelet agents (baby aspirin allowed)
  • Use of quinolone antibiotics within 10 days prior to registration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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