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CAR T-cell Therapy
CAR-T Cell Therapy for Multiple Myeloma (LMY-920-002 Trial)
Phase 1
Recruiting
Led By Leland Metheny, MD
Research Sponsored by Luminary Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiac ejection fraction of >45%, and no evidence of pericardial effusion, as determined by an echocardiogram.
Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
LMY-920-002 Trial Summary
This trial will test a new type of CAR-T cell to see if it can help people with myeloma who have relapsed after previous CAR-T cell treatment.
Who is the study for?
This trial is for adults over 18 with myeloma that's come back or hasn't responded after at least three treatments, including specific drugs. They must have measurable disease, be in relatively good health (ECOG ≤ 2), and not pregnant or breastfeeding. Participants need functioning major organs and can't have had certain other cancers or heart, lung, liver problems.Check my eligibility
What is being tested?
The study tests a new CAR-T cell therapy using BAFF-ligand on patients whose myeloma has relapsed or is refractory to treatment. It's an early-phase trial to see how well these modified immune cells work against cancer that didn’t respond to previous therapies like BCMA targeting CAR-T cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system attacking normal cells, such as fever and fatigue (cytokine release syndrome), nerve damage symptoms (neurotoxicity), low blood cell counts increasing infection risk, and organ inflammation.
LMY-920-002 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps well and I don't have fluid around it.
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My oxygen level is 92% or higher without extra oxygen.
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I agree to not have sex or use birth control and not donate sperm.
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I can take care of myself but might not be able to do heavy physical work.
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My myeloma has returned or didn't respond after 3 treatments including specific drugs.
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My cancer has not spread to my brain or spinal cord.
LMY-920-002 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine recommended phase II dose of human LMY-920 in patients with relapsed or refractory myeloma.
Secondary outcome measures
To determine incidence of adverse events
To determine incidence of anti- LMY-920 antibodies
To determine the complete response rate per International Myeloma Working Group uniform response criteria after treatment with LMY-920 in patients with relapsed or refractory myeloma.
+5 moreLMY-920-002 Trial Design
1Treatment groups
Experimental Treatment
Group I: LMY-920 dose escalationExperimental Treatment1 Intervention
Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicOTHER
1,030 Previous Clinical Trials
1,363,988 Total Patients Enrolled
9 Trials studying Multiple Myeloma
175 Patients Enrolled for Multiple Myeloma
Case Western Reserve UniversityOTHER
300 Previous Clinical Trials
246,592 Total Patients Enrolled
Luminary TherapeuticsLead Sponsor
2 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart pumps well and I don't have fluid around it.My oxygen level is 92% or higher without extra oxygen.I agree to not have sex or use birth control and not donate sperm.You have a disease that can be measured at the time of joining the study.You have a high level of M-protein in your blood.I have another cancer that needs treatment through the bloodstream.I can take care of myself but might not be able to do heavy physical work.You have a high level of M-protein in your urine.I have an autoimmune disease and needed strong medication for it within the last 6 months.I am experiencing complications from a transplant.My tests show early signs of a bone marrow disorder before starting treatment.My myeloma has returned or didn't respond after 3 treatments including specific drugs.My cancer has not spread to my brain or spinal cord.I have hepatitis but my PCR test for it is negative.I do not have any severe illnesses that would stop me from following the study's requirements.Your liver enzymes (AST and ALT) are not more than 2.5 times the normal limit.Your serum creatinine level is less than 2 mg/dL.I have an active cancer other than non-dangerous skin cancer or early-stage cancers.I can understand and am willing to sign the consent form.I have had a stem cell transplant from a donor.I have had a stem cell transplant within the last 6 weeks.I am not pregnant or breastfeeding and have a negative pregnancy test.I am HIV positive.I do not have active brain or spinal cord involvement by my cancer.I am currently receiving IV treatment for an infection.I am over 18 years old.I have severe heart failure.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.I have a history of significant brain-related health issues.It has been over 2 weeks since my last radiation or systemic therapy.More than 30% of your bone marrow cells are plasma cells.Your blood test shows high levels of a specific type of protein called free light chain, and the ratio of different types of free light chains in your blood is abnormal.Your total bilirubin level should be less than 1.5 mg/dL, unless you have Gilbert's syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: LMY-920 dose escalation
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 this medical experiment currently recruiting participants?
"The clinical trial's profile on clinicaltrials.gov reveals that it is no longer looking for participants, as the initial post was made November 1st 2022 and last modified September 15th 2022. Despite this, there are 807 additional trials recruiting patients at present moment."
Answered by AI
What potential risks do patients face when undergoing Autologous CAR-T cell therapy expressing the BAFF-ligand?
"This Autologous CAR-T Cell Therapy expressing the BAFF-ligand has limited data supporting its safety and efficacy, so our experts assigned it a score of 1."
Answered by AI
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