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

NCT06940297 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: MC240801NCI-2025-0249024-002915P50CA186781
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Minimal residual disease (MRD) negativity rate

  Defined as the number of patients who are able to achieve undetectable MRD based on bone marrow (BM) and positron emission tomography (PET) evaluations.

  At 3 months

Secondary Outcomes (5)

• Overall response rate (ORR)

  Up to 2 years

• Depth of response

  Up to 2 years

• Progression free survival (PFS)

  Up to 2 years

• Duration of response

  Up to 2 years

• Incidence of adverse events (AEs)

  Up to 2 years

Study Arms (1)

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

EXPERIMENTAL

Patients receive dasatinib by mouth (PO) once a day (QD) and quercetin PO twice a day (BID) on days -7 and -6 and cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive CAR-T IV on day 0. Patients receive dasatinib PO QD and quercetin PO BID on days 28, 29, 58, 59, 88 and 89 in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET, tumor biopsy, bone marrow aspirate and biopsy and blood sample collection throughout the study.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Biological: Ciltacabtagene Autoleucel; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Dasatinib; Drug: Fludarabine; Procedure: Positron Emission Tomography; Drug: Quercetin

Interventions

Biopsy Procedure PROCEDURE

Undergo tumor biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Ciltacabtagene Autoleucel BIOLOGICAL

Given IV

Also known as: Autologous Anti-B-cell maturation antigen (BCMA) CAR-T Cells JNJ-68284528, Autologous Bi-epitope BCMA-targeted CAR T-cells JNJ-68284528, Autologous Bi-epitope CAR T-cells JNJ-68284528, CARVYKTI, Cilta-cel, JNJ 68284528, JNJ-68284528, JNJ68284528, LCAR B38M, LCAR-B38M, LCAR-B38M-transduced CAR-T Cells JNJ-68284528, LCARB38M, Autologous Anti-BCMA CAR-T Cells JNJ-68284528

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Dasatinib DRUG

Given PO

Also known as: BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Fludarabine DRUG

Given IV

Also known as: Fluradosa

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Quercetin DRUG

Given PO

Also known as: 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one, 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-chromen-4-one, C.I. Natural Yellow 10

Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Relapsed or refractory multiple myeloma who has had at least 3 prior lines of therapies including a proteasome inhibitor, immunomodulatory drug (IMiD) and anti-CD38 monoclonal antibody (mAb)
• Ciltacabtagene autoleucel (Carvykti) available for patient
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Life expectancy ≥ 12 weeks
• Hemoglobin ≥ 8.0 g/dL (obtained ≤ 14 days prior to registration)
• Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (obtained ≤ 14 days prior to registration)
• Platelet count ≥ 50,000/mm\^3 (obtained ≤ 14 days prior to registration)
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)
• Note: Patients with Gilbert's syndrome must have a total bilirubin of ≤ 3 x ULN (obtained ≤ 14 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 x ULN (obtained ≤ 14 days prior to registration)
• Alkaline phosphatase ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration)
• Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
• Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

You may not qualify if:

• Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis
• Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.
• EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 1 month since completion of prior treatment
• Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
• Major surgery ≤ 28 days prior to registration
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients and patients known to be HIV positive.
• NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, or those currently receiving antiretroviral therapy with good control of HIV, are eligible for this trial
• Evidence of cardiovascular disease risk, as defined by any of the following:
• Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block
• History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
• Class III or IV heart failure as defined by the New York Heart Association functional classification system

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Biopsy; Specimen Handling; bis(3-bis(4-chlorophenyl)methyl-4-dimethylaminophenyl)amine; Cyclophosphamide; Dasatinib; fludarabine; Magnetic Resonance Spectroscopy; Quercetin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Spectrum Analysis; Chemistry Techniques, Analytical; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yi Lin, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): August 15, 2031
• Study Completion (Estimated): August 15, 2031
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)