Phase II Study of Dasatinib and Quercetin Combined with CAR-T Cell Therapy for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the combination of dasatinib and quercetin with chemotherapy and CAR-T cell therapy in patients with relapsed or refractory multiple myeloma, a type of cancer that has returned or not responded to previous treatments. This phase II study aims to understand how well this combination works in killing cancer cells and improving patient outcomes. The study is led by the Mayo Clinic and focuses on patients who have already undergone multiple prior therapies. Participants receive dasatinib and quercetin by mouth on specific days before and after chemotherapy and CAR-T cell therapy. Chemotherapy drugs cyclophosphamide and fludarabine are given intravenously in the days leading up to the CAR-T cell infusion. The CAR-T cell therapy, where the patients immune cells are modified to attack cancer, is given by intravenous infusion on day 0. Additional cycles of dasatinib and quercetin are given at later days if the disease does not progress or if side effects are acceptable. Throughout the study, patients undergo various scans, tumor biopsies, bone marrow procedures, and blood collections to monitor their condition. During the study, participants will be regularly assessed with imaging tests such as CT and PET scans, tumor biopsies, bone marrow aspirates and biopsies, and blood tests. Researchers will measure outcomes including minimal residual disease negativity at 3 months and track response rates, progression-free survival, duration of response, and adverse events for up to 2 years. Patients are expected to return for follow-up visits during the active monitoring phase. The total participation time may last up to several years, depending on individual responses and study timelines.

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