New immune therapy targets Hard-to-Treat multiple myeloma
NCT ID NCT05411497
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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5 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Four-Drug combo aims to push High-Risk myeloma into deep remission
- Blood cancer transplant study tests safer GVHD prevention
- New hope for hard-to-treat myeloma: three-drug combo enters phase 2 trial
- Stem cell transplant study seeks best way to prevent immune attack
- New immune cell therapy takes on Hard-to-Treat myeloma
- New combo tackles resistant myeloma in early trial