Actively Recruiting
LMY-920 for Treatment of Relapsed or Refractory Myeloma
Led by Luminary Therapeutics · Updated on 2024-10-18
30
Participants Needed
1
Research Sites
85 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
Since CAR-T cell treatment of refractory myeloma has shown success, based on preclinical data, we posit that CAR-T cells expressing B-cell activating factor (BAFF) can become another strategy to treat refractory myeloma, even after relapse following BCMA targeting CAR-T cell treatment. This will be phase 1 study of BAFF ligand CAR-T cells in relapsed and refractory myeloma.
CONDITIONS
Official Title
LMY-920 for Treatment of Relapsed or Refractory Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed multiple myeloma relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody
- No evidence of central nervous system (CNS) myeloma
- Male or female aged over 18 years
- ECOG Performance status of 2 or less
- Measurable disease by at least one of the following: serum M-protein 0.5 g/dL, urine M-protein 200 mg/24hr, serum free light chain involved light chain 10 mg/dL with abnormal ratio, or bone marrow plasma cells 30% of total marrow cells
- More than 2 weeks since prior radiation or systemic therapy at leukapheresis
- Total bilirubin 1.5 mg/dL (except Gilbert's syndrome)
- AST (SGOT)/ALT 2.5 times institutional upper limit of normal
- Serum creatinine less than 2 mg/dL
- Cardiac ejection fraction greater than 45% with no pericardial effusion
- Adequate pulmonary function with pulse oximetry 92% on room air
- Ability and willingness to provide informed consent
- For women of childbearing potential: agreement to abstain from heterosexual intercourse or use effective contraception during treatment and for 90 days after infusion
- For men: agreement to abstain from heterosexual intercourse or use contraception and to avoid sperm donation
You will not qualify if you...
- Autologous stem cell transplant within 6 weeks prior to consent
- History of allogeneic hematopoietic stem cell transplantation
- Active graft-versus-host disease
- Active CNS or meningeal involvement by myeloma, or untreated brain metastases/CNS disease
- Active malignancy other than non-melanoma skin cancer or carcinoma in situ
- Less than 28 days since prior investigational treatment before lymphocyte collection
- New York Heart Association class IV congestive heart failure
- Cardiovascular disorders including unstable angina, serious arrhythmias, myocardial infarction, or stroke within 6 months
- 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 confirmed by PCR
- History of significant CNS disease such as epilepsy, seizure disorders, severe brain injuries, dementia, or Parkinson's disease
- Uncontrolled illness including infection, heart failure, angina, arrhythmia, pulmonary issues, or psychiatric/social issues limiting compliance
- Known additional malignancies requiring systemic treatment
- Autoimmune disease requiring immunosuppressive medications (other than low dose steroids) within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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