What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving immunotherapy and T-cell-based approaches like MUC1-activated T cells, often have side effects such as cytokine release syndrome (CRS), which includes symptoms like fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Neurotoxicity, leading to confusion, seizures, or severe headaches, is also a significant concern. Additionally, neutropenia, which increases infection risk, and other immune-related adverse events, such as organ inflammation, are notable side effects. These potential adverse effects necessitate careful patient management and monitoring.

What prior FDA approvals exist?

FDA approvals for the treatment of Multiple Myeloma have included several immunotherapy approaches similar to MUC1-activated T cells. Notably, chimeric antigen receptor (CAR) T-cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel have been approved for relapsed or refractory multiple myeloma. These therapies involve engineering a patient's T cells to target the B-cell maturation antigen (BCMA) on myeloma cells. Additionally, bispecific T cell engagers (BiTEs) like teclistamab, which also target BCMA, have shown promise. These treatments are part of a broader trend in using the body's immune system to identify and kill cancer cells, similar to the approach being studied with MUC1-activated T cells.

What other types of research exist?

Promising novel alternatives to MUC1-activated T cells for Multiple Myeloma patients include CAR T-cell therapies targeting other antigens such as BCMA (B-cell maturation antigen), bispecific antibodies like teclistamab, and novel agents such as selinexor (a selective inhibitor of nuclear export). These therapies have shown significant efficacy in clinical trials and are expected to be important treatment options in 2024.

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CAR T-cell Therapy

MUC1-Activated T-Cells for Multiple Myeloma

Phase 1

Recruiting

Led By Leif Bergsagel

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to undergo leukapheresis for blood component collection

Patients with extramedullary disease must meet specific lesion size criteria

Must not have

Patients requiring chronic supraphysiologic daily doses of steroids

History of myocardial infarction >= 6 months prior to registration, and/or congestive heart failure requiring ongoing treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to immune response such as fever, fatigue, chills; possible damage to non-target cells causing unintended organ inflammation; and typical chemotherapy-related issues like nausea or hair loss from Cyclophosphamide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am fully active or can carry out light work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am HIV positive and currently on antiretroviral therapy.

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

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I have been diagnosed with plasma cell leukemia.

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I have received treatments targeting MUC1.

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I have untreated or ongoing brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Clinical response

Overall survival

Progression-free survival

Other study objectives

MUC1 expression (bone marrow aspirate)

MUC1 expression (bone marrow biopsy tissue/slides)

Pharmacodynamics, adoptive T cells immunophenotyping TCRVbeta

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include immunotherapies, proteasome inhibitors, and monoclonal antibodies. Immunotherapies, such as the MUC1-activated T cells, involve genetically engineering a patient's T cells to target and kill cancer cells expressing the MUC1 protein, enhancing the body's immune response against the cancer. Proteasome inhibitors, like bortezomib, disrupt the protein degradation process in cancer cells, leading to cell death. Monoclonal antibodies, such as daratumumab, target specific antigens on myeloma cells, marking them for destruction by the immune system. These treatments are crucial as they offer targeted approaches to eliminate cancer cells, potentially leading to better outcomes and fewer side effects for Multiple Myeloma patients.

Latest developments in MUC1 immunotherapy.Stem cell transplantation in multiple myeloma and other plasma cell disorders (report from an EBMT preceptorship meeting).