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CAR T-cell Therapy
Immunotherapy for Multiple Myeloma
Phase 1
Waitlist Available
Led By Sarah Larson
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years old and =< 74 years old
Diagnosis of multiple myeloma relapsed or refractory after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent either alone or in combination, and anti-CD38 directed therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the date of cart-bcma/cs1 cell infusion in the study until death, assessed up to 15 years
Awards & highlights
Study Summary
This trial studies modified T cells to see how well they work in treating MM that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults aged 18-74 with multiple myeloma that's resistant or has returned after at least three treatments, including specific inhibitors and immunotherapies. Participants must have measurable disease, be in good physical condition, and able to undergo leukapheresis. They can't join if they've had certain other cancers recently, active hepatitis B/C, HIV, dementia, severe heart or lung issues, are pregnant/breastfeeding without contraception use or have used systemic steroids recently.Check my eligibility
What is being tested?
The trial tests CART-BCMA/CS1 therapy on patients with relapsed/refractory multiple myeloma. It involves modifying the patient's T cells to target cancer cells more effectively. The process includes bone marrow procedures and imaging tests before infusing engineered T cells back into the patient to attack the cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever and fatigue (cytokine release syndrome), neurological issues like confusion or seizures (neurotoxicity), blood cell count changes leading to increased infection risk or bleeding problems, and possible organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 74 years old.
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My multiple myeloma has returned or didn't respond after 3 treatments including a proteasome inhibitor, an immunomodulatory agent, and anti-CD38 therapy.
Select...
My multiple myeloma can be measured by specific blood or urine tests.
Select...
I am willing to undergo a procedure to collect white blood cells.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function is good enough for the trial, based on recent tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the date of cart-bcma/cs1 cell infusion in the study until death, assessed up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the date of cart-bcma/cs1 cell infusion in the study until death, assessed up to 15 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 dose limiting toxicities (DLTs)
Secondary outcome measures
CART-BCMA/CS1 cell persistence
Clinical response rate
Duration of response
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CART-BCMA/CS1)Experimental Treatment11 Interventions
Patients undergo leukapheresis on 35 to 21 days before Infusion Day (I-Day -35 to I-Day -21) and receive cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on I-Days -5, -4, and -3. Patients then receive CART-BCMA/CS1 IV on I-Day-0 on study. Patients undergo ECHO, ECG and MRI during screening. Patients undergo bone marrow biopsy and/or bone marrow aspirate screening, between I-Day -28 to I-Day -5, I-Day 30, and at 1 year post CART-BCMA/CS1 infusion. Patients also undergo FDG PET/CT during screening, between I-Day -28 to I-Day -5, I-Day 90 and I-Day 180 and every 3 months thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Echocardiography
2013
Completed Phase 4
~11670
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Leukapheresis
2016
Completed Phase 2
~690
Cyclophosphamide
1995
Completed Phase 3
~3770
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,020 Total Patients Enrolled
7 Trials studying Multiple Myeloma
133 Patients Enrolled for Multiple Myeloma
Sarah LarsonPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hepatitis B or C and it's currently harming my liver.Your heart's pumping ability is less than 45%.I am between 18 and 74 years old.My multiple myeloma has returned or didn't respond after 3 treatments including a proteasome inhibitor, an immunomodulatory agent, and anti-CD38 therapy.I may need or have recently used systemic steroids, but not inhaled or topical ones.My cancer has spread to my brain or spinal cord.I had a stem cell transplant using my own cells within the last 12 weeks.I have had cancer in the past 3 years, but it may be an exception.I've had anti-BCMA therapy without severe side effects.My multiple myeloma can be measured by specific blood or urine tests.I am not pregnant or breastfeeding, and if I can have children, I agree to use birth control during and for 6 months after treatment.I am mentally capable of understanding and following the study's requirements.My white blood cell count is high enough for treatment.Your bilirubin levels should be within a certain range, unless you have Gilbert's syndrome.Your oxygen level is 92% or lower when breathing regular air.I am willing to undergo a procedure to collect white blood cells.I have had a stem cell transplant from a donor.I've had treatment for multiple myeloma within the last 2 weeks.You have HIV or other conditions that weaken your immune system.I am fully active or restricted in physically strenuous activity but can do light work.Unable to collect at least 500 million CD62L-enriched cells from a blood collection process.You have had a bad reaction to any of the medications used in this study, or you are sensitive to cyclophosphamide or fludarabine.My hemoglobin level is at least 8 g/dL.Your liver enzymes (AST, ALT) should not be more than 2.5 times the normal level.My platelet count is at least 50, without needing a transfusion recently.My kidney function is good enough for the trial, based on recent tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CART-BCMA/CS1)
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.
Does the age range for this research include individuals younger than sixty?
"This study is seeking volunteers aged between 18 and 74 years old."
Answered by AI
What adverse effects might arise from Treatment (CART-BCMA/CS1) for those receiving it?
"Due to the limited data available, Treatment (CART-BCMA/CS1) received a score of 1 for safety. This is because it is still in its initial phase and there have been no significant findings regarding efficacy or safeguarding protocols."
Answered by AI
Is this medical study actively inviting participants?
"According to the clinicaltrial.gov database, this medical trial is currently not recruiting patients as its last update was on July 10th 2023. Despite that fact, 819 other studies are actively searching for participants right now."
Answered by AI
What criteria must potential participants meet in order to be involved in this clinical experiment?
"For eligibility in this medical trial, individuals must be diagnosed with multiple myeloma and aged between 18 to 74 years old. Approximately 30 participants are being accepted into the study."
Answered by AI
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