Study on Dasatinib and Quercetin with CAR-T Therapy for Treating Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06940297

This clinical trial is exploring a new treatment combination using dasatinib, quercetin, and CAR-T cell therapy to help patients with multiple myeloma that has returned or not responded to previous treatments. The study aims to see if this combination can effectively kill more cancer cells.

Patient Parameters

Program Overview

This phase II study is testing a new treatment approach for patients with multiple myeloma that has either come back after treatment or hasn't responded to previous therapies. The treatment combines dasatinib, a drug that blocks cancer cell growth, and quercetin, a plant compound that may prevent cancer formation, with chemotherapy drugs cyclophosphamide and fludarabine. These drugs help prepare the body for CAR-T cell therapy, a treatment where a patient's immune cells are modified to attack cancer cells. The goal is to see if this combination can kill more cancer cells in patients with relapsed or refractory multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have relapsed or refractory multiple myeloma and have tried at least three different treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
  • Have access to a specific CAR-T cell therapy called Ciltacabtagene autoleucel (Carvykti).
  • Have measurable disease.
  • Be in relatively good health with an ECOG performance status of 0, 1, or 2.
  • Have a life expectancy of at least 12 weeks.
  • Meet specific blood count and organ function requirements based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Agree to use effective contraception during the study and for 30 days after the last dose.
  • Be willing to provide blood and bone marrow samples for research.
  • Agree to return to the study site for follow-up visits.

Exclusion Criteria

  • Have conditions like monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis.
  • Have not fully recovered from previous treatments, except for stable mild nerve damage.
  • Be pregnant, nursing, or unwilling to use contraception if of childbearing potential.
  • Have had major surgery within 28 days before joining the study.
  • Have severe health issues that could interfere with the study.
  • Be immunocompromised or have uncontrolled HIV, unless well-managed.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have active infections or other serious illnesses.
  • Be taking other investigational drugs or have received a live vaccine recently.
  • Be on certain medications that interact with the study drugs, like strong CYP3A4/5 inhibitors or inducers.
  • Have allergies to dasatinib or quercetin.
  • Be on blood thinners or certain antiplatelet medications, except for low-dose aspirin if needed for heart protection.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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