Actively Recruiting
Phase 1 Study of BAFF CAR T Cells (LMY-920) for Treatment of Relapsed or Refractory Multiple Myeloma
Led by Luminary Therapeutics · Updated on 2024-10-18
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
L
Luminary Therapeutics
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called LMY-920, which consists of CAR-T cells expressing the B-cell activating factor (BAFF) ligand, for people with relapsed or refractory multiple myeloma. This phase 1 study aims to find the recommended dose for further testing by assessing safety and treatment responses in patients whose myeloma has returned or not responded after multiple prior therapies, including other CAR-T treatments targeting BCMA. The study involves an open-label dose escalation of up to four levels of LMY-920 CAR-T cells given to participants. The maximum tolerated dose will be identified using a standard 3+3 design. Participants will receive their own modified T cells engineered to target the BAFF receptor family, including BCMA and other related receptors. The treatment is given as a single infusion, and participants will be closely monitored for side effects and response. During the study, participants will undergo regular assessments including blood tests, bone marrow evaluations, and disease measurements based on defined myeloma response criteria. Researchers will track safety, response rates, duration of response, progression-free and overall survival, and immune reactions over 24 months. The study includes detailed monitoring to determine the best dose and understand the treatment's effects in this patient group.
CONDITIONS
Brief Title
LMY-920 for Treatment of Relapsed or Refractory Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have confirmed relapsed or refractory myeloma after 3 or more prior therapies including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody
- No evidence of central nervous system (CNS) myeloma
- Male or female aged 18 years or older
- ECOG performance status of 0 to 2
- Measurable disease by serum M-protein, urine M-protein, serum free light chain assay, or bone marrow plasma cells
- More than 2 weeks since last radiation or systemic therapy before leukapheresis
- Total bilirubin less than or equal to 1.5 mg/dL (except Gilbert's syndrome)
- AST and ALT less than or equal to 2.5 times upper limit of normal
- Serum creatinine less than 2 mg/dL
- Cardiac ejection fraction greater than 45% with no pericardial effusion
- Adequate lung function with pulse oximetry at least 92% on room air
- Ability to understand and sign informed consent
- Women of childbearing potential must agree to abstain or use effective contraception during treatment and for 90 days after
- Men must agree to abstain or use contraception and refrain from sperm donation
You will not qualify if you...
- Autologous stem cell transplant within 6 weeks before consent
- History of allogeneic hematopoietic stem cell transplant
- Active graft-versus-host disease
- Active CNS or meningeal myeloma involvement or untreated brain metastases
- Active malignancy other than certain skin or in situ cancers
- Less than 28 days since prior investigational treatment before lymphocyte collection
- Severe heart failure or recent significant cardiac events
- Active infection requiring intravenous treatment
- HIV positive status
- Pregnant or breastfeeding women
- Evidence of myelodysplasia or related cytogenetic abnormalities
- Active hepatitis B or C infection
- History of significant CNS disorders like epilepsy or dementia
- Uncontrolled illnesses including infections, heart failure, or psychiatric conditions
- Additional malignancies requiring treatment
- Autoimmune diseases requiring immunosuppressants other than low dose steroids within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks depending on dose escalation and participant response
Participants receive autologous CAR-T cell therapy expressing the BAFF-ligand (LMY-920) in a dose escalation study for relapsed or refractory myeloma.
1 treatment visit and multiple follow-up visits during dose escalation
Duration - Up to 24 months
Participants are monitored for safety, response, and adverse events for up to 24 months after treatment.
Regular visits over 24 months for monitoring
Trial Site Locations
Total: 1 location
1
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
L
Leland Metheny, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here