MUC1-Activated T-Cells for Multiple Myeloma

Recruiting at1 trial location

Overseen by Leif 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.

Research Team

Leif Bergsagel, M.D.

Principal Investigator

Mayo Clinic Hospital in Arizona

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.

Your oxygen level is 90% or higher when you breathe normally.

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

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 do not have any uncontrolled illnesses.

Treatment Details

Interventions

• Autologous MUC1-activated T-cells (CAR T-cell Therapy)
• Cyclophosphamide (Alkylating agents)

Trial Overview 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.

Participant Groups

Group I: Treatment (cyclophosphamide, MUC1-activated T-cells) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School