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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Pregnant persons

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Ciltacabtagene Autoleucel

    Biological/Vaccine

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Cyclophosphamide

    Drug

    Given IV

  • Dasatinib

    Drug

    Given PO

  • Fludarabine

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Quercetin

    Drug

    Given PO

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)Experimental treatment 11 interventions

Trial outcomes

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.

Time frame
At 3 months

Secondary outcomes

1

Overall response rate (ORR)

Assessed by the number of patients who achieve any response (partial response or better) to therapy.

Time frame
Up to 2 years
2

Depth of response

Assessed by the number of patients who are able to achieve different levels of response, such as partial response (PR), very good partial response (VGPR), and complete response (CR), or stringent complete response (sCR).

Time frame
Up to 2 years
3

Progression free survival (PFS)

Defined as the time from study registration to the time of documented disease progression or death due to any cause.

Time frame
Up to 2 years
4

Duration of response

Defined as the time from first documented response to the time of progression and/or death due to any cause.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator