Dasatinib + Quercetin With CAR-T Therapy for Multiple Myeloma

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Antiplatelets, Quinolones, CYP3A4/5 inhibitors

Disqualifiers: HIV, Cardiovascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for people with multiple myeloma, a type of blood cancer that has either returned or not responded to previous treatments. It combines dasatinib, a drug that blocks cancer cell growth, and quercetin, a plant compound, with chemotherapy and CAR-T therapy, which uses modified immune cells to target cancer. The goal is to determine if this combination can kill more cancer cells. Those who have undergone at least three different treatments and still have active multiple myeloma might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to benefit from innovative therapies.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot take certain medications like strong CYP3A4/5 inhibitors or inducers, therapeutic doses of anticoagulants, or antiplatelet agents. If you are on these, you may need to adjust or stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CAR-T cell therapies, a key component of this treatment, have been generally safe in early trials for multiple myeloma. However, they can sometimes cause side effects like fever or low blood cell counts. Previous studies on dasatinib, a drug that blocks signals aiding cancer cell growth, and quercetin, a plant compound, suggest they are usually well-tolerated. Some patients might experience mild side effects like nausea or tiredness, but serious side effects are less common. Since this trial is in phase 2, earlier trials have already tested dasatinib and quercetin for basic safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Dasatinib and Quercetin with CAR-T therapy for multiple myeloma because this approach may offer a more targeted and effective treatment. Unlike standard treatments like chemotherapy and stem cell transplants, this combination leverages Dasatinib and Quercetin to potentially enhance the efficacy of CAR-T cells, which are engineered to specifically target and destroy cancer cells. This unique combination aims to improve the precision and durability of the treatment, possibly leading to better outcomes for patients with fewer side effects.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that combining dasatinib, quercetin, and CAR-T cell therapy, as studied in this trial, may effectively target and kill cancer cells in people with multiple myeloma. Participants in this trial will receive dasatinib, which blocks proteins that help cancer cells grow, potentially stopping them from spreading. Quercetin, also part of the trial treatment, may help prevent cancer from forming, adding extra protection. CAR-T therapy, another component of the trial, modifies a patient's immune cells to directly attack cancer cells, providing a strong treatment option. Together, these treatments may improve outcomes for patients whose multiple myeloma has returned or is difficult to treat. ^{1 2 3 4 5}

Who Is on the Research Team?

Yi Lin, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with multiple myeloma that has either returned after getting better (relapsed) or hasn't improved with treatment (refractory). Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the specifics of their cancer.

Inclusion Criteria

Life expectancy ≥ 12 weeks

Hemoglobin ≥ 8.0 g/dL

Absolute neutrophil count (ANC) ≥ 1,000/mm^3

Exclusion Criteria

Pregnant, nursing, or unwilling to employ adequate contraception

Receiving other investigational agents for primary neoplasm

Known hypersensitivity or allergy to dasatinib or quercetin

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants receive dasatinib and quercetin orally on days -7 and -6, followed by cyclophosphamide and fludarabine intravenously on days -5 to -3

1 week

Daily visits for drug administration

CAR-T Cell Infusion

Participants receive CAR-T cell therapy intravenously on day 0

1 day

1 visit (in-person)

Post-Treatment Monitoring

Participants receive dasatinib and quercetin on days 28, 29, 58, 59, 88, and 89, and undergo various assessments including CT scan, PET, tumor biopsy, and blood and urine sample collection

3 months

Multiple visits for assessments and drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Ciltacabtagene Autoleucel
• Dasatinib
• Quercetin

Trial Overview The study tests dasatinib and quercetin combined with cyclophosphamide, fludarabine, and CAR-T cell therapy. Dasatinib blocks proteins that tell cancer cells to grow; quercetin may prevent cancer formation. The chemotherapy drugs kill remaining cancer cells before the modified T cells are reintroduced to attack the cancer.

How Is the Trial Designed?

Group I: Treatment (Dasatinib, quercetin, chemotherapy, CAR-T) Experimental Treatment 11 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

T-cell redirecting bispecific antibodies and CAR T cells are effective treatments for multiple myeloma but are associated with significant adverse events, including cytokine release syndrome and neurotoxicity.

The European Myeloma Network recommends specific management strategies for these adverse events, such as premedication, corticosteroids, and monitoring for symptoms, to improve patient safety and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and management of adverse events during treatment with bispecific antibodies and CAR T cells in multiple myeloma: a consensus report of the European Myeloma Network. Ludwig, H., Terpos, E., van de Donk, N., et al.[2023]

Chimeric antigen receptor (CAR)-modified T cell therapy has shown promising efficacy in treating refractory or relapsed multiple myeloma (MM) in both preclinical and clinical studies, indicating a potential new treatment avenue for this incurable disease.

The toxicities associated with CAR-T cell therapy are manageable, suggesting that this innovative approach could be a safe option for patients with MM, especially as research continues to identify effective targets and improve technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor T cell therapies for multiple myeloma. Wu, C., Zhang, L., Brockman, QR., et al.[2020]

The introduction of new therapies, including proteasome inhibitors, immunomodulators, and various immunotherapies like CAR T-cell treatments, has significantly improved the five-year survival rate for multiple myeloma to nearly 60%.

Despite these advancements, multiple myeloma remains incurable, as patients often become resistant to treatments and experience relapses, highlighting the need for ongoing research and development of new therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future. Abramson, HN.[2023]

CAR-T cell therapies targeting B-cell maturation antigen have shown significant effectiveness against multiple myeloma in early clinical trials, indicating a promising new treatment approach for this challenging cancer.

Toxicities observed in these CAR-T trials, such as cytokine release syndrome, are similar to those seen in CAR-T therapies for other blood cancers, highlighting the need for careful monitoring and management in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor T-cell therapies for multiple myeloma. Mikkilineni, L., Kochenderfer, JN.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06940297?term=dasatinib%2Bquercetin&viewType=Table&rank=10

Dasatinib and Quercetin With CAR-T Therapy for the ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. withpower.com withpower.com/trial/phase-2-multiple-myeloma-4-2025-a4e07

Dasatinib + Quercetin With CAR-T Therapy for Multiple ... This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06940297

NCT06940297 | Dasatinib and Quercetin With CAR-T ... Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory ...

4. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/multiple-myeloma

Multiple Myeloma Clinical Trials This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works ...

5. trialx.com trialx.com/clinical-trials/listings/310029/dasatinib-and-quercetin-with-car-t-therapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma/

Dasatinib and Quercetin With CAR-T Therapy for the ... Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory ...