MUC1-Activated T-Cells for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByLeif Bergsagel, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a treatment using modified T cells to target a specific protein on cancer cells in patients with difficult-to-treat multiple myeloma. The goal is to see if these specially trained cells can help the immune system kill cancer cells more effectively. This new method for cancer treatment shows promise in treating multiple myeloma.

Eligibility Criteria

This trial is for adults over 18 with recurrent or treatment-resistant multiple myeloma that expresses MUC1. Participants must have tried at least three prior therapies, including a proteasome inhibitor, an IMiD, and a CD38 antibody. They should be in good general health with stable vital signs and able to provide consent. Pregnant or nursing individuals and those unwilling to use birth control are excluded.

Inclusion Criteria

I am willing to have a procedure to collect blood components.

My cancer outside the bone marrow meets the required size criteria.

I am fully active or can carry out light work.

I am 18 years old or older.

Exclusion Criteria

I need high doses of steroids every day for my condition.

I had a heart attack more than 6 months ago or I am being treated for heart failure.

I am HIV positive and currently on antiretroviral therapy.

I still have side effects from previous treatments, except for mild, stable nerve issues.

I have been diagnosed with plasma cell leukemia.

I have received treatments targeting MUC1.

I have untreated or ongoing brain metastases.

Participant Groups

The trial tests genetically engineered T-cells designed to target the MUC1 marker on cancer cells in patients with multiple myeloma. It aims to find the safest dose of these modified T-cells when combined with Cyclophosphamide, assessing how well they help the immune system fight cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment (cyclophosphamide, MUC1-activated T-cells)Experimental Treatment2 Interventions

LD CHEMOTHERAPY: Patients receive cyclophosphamide IV over 60 minutes on days -5, -4, -3. ASCT: Patients receive MUC1-activated T-cells IV over 10 minutes to 1 hour on day 0.