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New immune therapy targets Hard-to-Treat multiple myeloma

NCT ID NCT05411497

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new treatment for multiple myeloma that has returned or stopped responding to standard therapies. The treatment uses a patient's own immune cells (T cells) that are specially trained to recognize and attack cancer cells carrying a protein called MUC1. The main goals are to check safety and find the best dose in a small group of 5 adults.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

5 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * MUC1 expression in multiple myeloma tumor cells verified by immunohistochemistry (IHC) or flow cytometry (FCM). Heterogeneous tumor expression of MUC1 is acceptable * Relapsed or refractory multiple myeloma previously treated with or intolerant to at least three prior lines of therapy and be relapsed or intolerant to a proteasome inhibitor, an immune modulatory drug (IMiD), and a CD38 antibody. Patients must be at least 90 days since an autologous stem cell transplant, if performed * Patients must have measurable disease per IMWG criteria on study entry, which must include at least one of the following: * Serum M-spike \>= 0.5 g/dL Patients with IgA, IgM or IgD myeloma in whom serum protein electrophoresis is deemed unreliable for routine M-protein quantitation may be considered eligible if total serum IgA, IgM or IgD level is elevated above normal range and parallels disease course * 24-hour urine M-spike \>= 200 mg * Involved serum free light chain (FLC) \>= 10 mg/L with an abnormal free light chain ratio * Bone marrow plasma cells \> 30% * Patients with extramedullary disease: * 1 lesion that has a single diameter of \>= 2 cm measured by computed tomography (CT) or magnetic resonance imaging (MRI) or the CT portion of the positron emission tomography (PET)/CT * Skin lesions can be used if the area is \>= 2cm in at least one diameter and measured with a ruler * Willingness and ability to provide written informed consent * Willing to return to Mayo Clinic Hospital in Arizona (MCA) for follow-up during the active monitoring phase of the study * Willingness to provide mandatory blood, bone marrow biopsy, and aspirate specimens for correlative research * Willing to undergo leukapheresis for blood component collection * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 14 days of study registration) * Lymphocyte count \>= 500/mm\^3 (within 14 days of study registration) * Hemoglobin \>= 8.0 g/dL (within 14 days of study registration) * Platelet count \>= 30,000/mm\^3 (within 14 days of study registration) * Total bilirubin =\< 2.0 mg/dL unless patient has documented Gilbert's syndrome (Subjects with Gilbert's Syndrome may be included if their total Bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN) (within 14 days of study registration) * Alanine aminotransferase (ALT) and aspartate amino transferase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement of their cancer) (within 14 days of study registration) * Prothrombin time, international normalized ratio (PT, INR) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis \[DVT\]/pulmonary embolism \[PE\] within the last 6 months of enrollment) * Calculated creatinine clearance \>= 30 ml/min using the Cockcroft-Gault formula (within 14 days of study registration) * Baseline oxygen saturation \>= 90% on room air Exclusion Criteria: * Clinically unresolved central nervous system (CNS) metastases * Prior treatment targeting MUC1 * Subjects with known plasma cell leukemia (PCL) * Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and/or teratogenic effects: * Pregnant persons * Nursing persons * Persons of childbearing potential who are unwilling to employ adequate birth control measures * History of myocardial infarction \>= 6 months prior to registration, and/or congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator to control life-threatening arrhythmias. * Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment. * Uncontrolled concurrent illness including, but not limited to: * Inability to clear an ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Uncontrolled psychiatric problems and/or difficult social situation * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy * Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements * Evidence of clinical immunocompromise and/or human immunodeficiency virus (HIV) positivity and currently receiving antiretroviral therapy * Patients requiring chronic supraphysiologic daily doses of steroids (\>10 mg prednisone or prednisolone, \>= 4 mg Decadron or \>= 50 mg hydrocortisol daily) * Patients receiving any other investigational agent which could be considered a treatment for the neoplasm * Other active malignancy first documented =\< 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

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Other studies related to the condition(s) this trial covers.