Actively Recruiting
DART: Phase II Study of Dasatinib and Quercetin with Chemotherapy and CAR-T Therapy for Relapsed or Refractory Multiple Myeloma
Led by Mayo Clinic · Updated on 2026-02-06
44
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating how well dasatinib and quercetin combined with cyclophosphamide, fludarabine, and CAR-T cell therapy work in treating patients with relapsed or refractory multiple myeloma. This phase II trial focuses on patients whose cancer has returned or not responded to previous treatments. Dasatinib is a drug that blocks cancer cell growth signals, while quercetin is a plant compound that may prevent cancer development. Chemotherapy is used to eliminate remaining cancer cells and prepare the bone marrow for CAR-T therapy, which modifies a patient's immune cells to attack cancer. Patients receive dasatinib by mouth once daily and quercetin twice daily on days -7 and -6 before chemotherapy with cyclophosphamide and fludarabine given intravenously from days -5 to -3. On day 0, patients receive CAR-T cell therapy through an infusion. Dasatinib and quercetin are given again on days 28, 29, 58, 59, 88, and 89, provided there is no disease progression or unacceptable side effects. This treatment schedule aims to enhance the ability of immune cells to target cancer. Throughout the study, participants will undergo CT and PET scans, tumor biopsies, bone marrow aspirations and biopsies, and blood sample collections to monitor their condition and response to treatment. The main outcome measured is the rate of minimal residual disease negativity at 3 months. Other outcomes include overall response, depth and duration of response, progression-free survival, and monitoring of side effects for up to 2 years. Participants will be followed closely to assess how well the treatment works and its safety.
CONDITIONS
Brief Title
Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma with at least 3 prior treatments including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody
- Availability of ciltacabtagene autoleucel (Carvykti) for the patient
- Eastern Cooperative Oncology Group 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 before registration
- Absolute neutrophil count of 1,000/mm3 or higher within 14 days before registration
- Platelet count of 50,000/mm3 or higher within 14 days before registration
- Total bilirubin at or below 1.5 times the upper limit of normal (up to 3 times for Gilbert's syndrome) within 14 days before registration
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) at or below 2 times the upper limit of normal within 14 days before registration
- Alkaline phosphatase at or below 1.5 times the upper limit of normal within 14 days before registration
- Calculated creatinine clearance of 30 ml/min or higher within 14 days before registration
- Negative pregnancy test within 7 days before registration for persons of childbearing potential
- Use of effective contraception by sexually active patients and their partners during and for 30 days after the study
- Written informed consent provided
- Willingness to provide mandatory blood and bone marrow samples for research
- Willingness to return to the enrolling institution for follow-up during the active monitoring phase
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 neuropathy for at least 1 month
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to use adequate contraception
- Major surgery within 28 days prior to registration
- Severe concurrent diseases or systemic illnesses interfering with safety assessment
- Immunocompromised patients or known HIV positive patients with immunocompromised state
- Clinically significant uncontrolled arrhythmias or ECG abnormalities, recent serious heart events or severe heart failure
- Uncontrolled hypertension or history of life-threatening ventricular arrhythmias
- QTC interval of 450 msec or more on ECG
- Uncontrolled infections or medical conditions making participation hazardous
- Receiving other investigational agents for the primary cancer
- Live vaccine within 6 weeks prior to registration
- Use of strong CYP3A4/5 inhibitors or inducers within 14 days prior to registration, including grapefruit or St. John's Wort
- Known allergy or hypersensitivity to dasatinib or quercetin
- Use of therapeutic doses of anticoagulants or antiplatelet agents, except low-dose aspirin for heart protection
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive dasatinib by mouth once daily and quercetin by mouth twice daily on days -7 and -6. They receive cyclophosphamide and fludarabine intravenously on days -5 to -3. On day 0, participants receive CAR-T therapy intravenously. Dasatinib and quercetin are again given on days 28, 29, 58, 59, 88, and 89 if there is no disease progression or unacceptable toxicity. Participants undergo CT and/or PET scans, tumor biopsy, bone marrow aspirate and biopsy, and blood sample collections throughout the study.
Multiple visits for treatment and assessments including imaging and biopsies
Duration - Up to 2 years
Participants are monitored for overall response, progression-free survival, duration of response, and adverse events for up to 2 years after treatment.
Periodic visits for up to 2 years
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
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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