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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses the body's own infection-fighting cells to target and kill cancer cells.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Clinical response
Overall survival
Progression-free survival
Other outcome measures
MUC1 expression (bone marrow aspirate)
MUC1 expression (bone marrow biopsy tissue/slides)
Pharmacodynamics, adoptive T cells immunophenotyping TCRVbeta
+3 moreSide effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
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
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,350 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,113 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,842 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,693 Patients Enrolled for Multiple Myeloma
Leif BergsagelPrincipal InvestigatorMayo Clinic Hospital in Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to have a procedure to collect blood components.Your oxygen level is 90% or higher when you breathe normally.I need high doses of steroids every day for my condition.My cancer outside the bone marrow meets the required size criteria.Patients must have a detectable disease according to specific guidelines at the start of the study.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.I have not been diagnosed with another cancer within the last 4 years.I am HIV positive and currently on antiretroviral therapy.Your blood and other body chemistry levels need to be within certain ranges.You are taking any other experimental medication for your condition.I am fully active or can carry out light work.My multiple myeloma has returned or didn't respond after 3 treatments including a proteasome inhibitor, an IMiD, and a CD38 antibody. It's been 90 days since my last stem cell transplant.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.I am 18 years old or older.My multiple myeloma cells show MUC1 presence.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclophosphamide, MUC1-activated T-cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the registration period for this experiment still available?
"According to the clinicaltrials.gov listing, this medical trial is actively recruiting participants as of June 23rd 2022; it was first announced on June 20th 2022."
Answered by AI
How many subjects are engaged in this experiment?
"Affirmative. Information available on clinicaltrials.gov attests to the active recruitment of 18 patients from 1 medical centre for this experiment, which was initially posted on June 20th 2022 and modified most recently on June 23rd 2022."
Answered by AI
To what extent could Autologous MUC1-activated T-cells be a potential hazard for individuals?
"As this is only a Phase 1 trial, there is limited evidence of autologous MUC1-activated T-cells safety and efficacy. Thus, our Power team has given it an overall rating of 1 on the risk scale."
Answered by AI
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