Actively Recruiting
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Led by Paolo Caimi, MD · Updated on 2025-11-10
18
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
P
Paolo Caimi, MD
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL/SLL, possibly secondary to the suppressive effect of circulating B cells on T cell function. BAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.
CONDITIONS
Official Title
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed chronic lymphocytic leukemia or small lymphocytic lymphoma relapsed after 2 or more lines of therapy including BTK and BCL2 inhibitors
- No evidence of central nervous system lymphoma
- Male or female aged 18 years or older
- ECOG performance status 0 to 2
- Presence of active disease for CLL and SLL, and measurable disease for SLL
- At least 2 weeks since prior radiation therapy or 5 half-lives for systemic therapy before leukapheresis
- Total bilirubin less than or equal to 1.5 times institutional normal (exceptions for certain conditions)
- AST/ALT less than or equal to 2.5 times institutional normal
- Creatinine clearance at least 30 ml/min
- Cardiac ejection fraction 50% or higher
- Pulse oximetry 92% or higher on room air
- Ability to understand and sign informed consent
- Women of childbearing potential must agree to abstinence or effective contraception during treatment and for 90 days after infusion
- Men must agree to abstinence or use contraception and avoid sperm donation during treatment and for 6 months after infusion
You will not qualify if you...
- Autologous stem cell transplant within 6 weeks of consent
- History of allogeneic stem cell transplant
- Active graft-versus-host disease
- Active central nervous system or meningeal lymphoma or leukemia involvement
- Active malignancy other than certain skin cancers or carcinoma in situ
- Additional malignancies requiring systemic treatment (exceptions may apply)
- Less than 28 days since prior investigational treatment before lymphocyte collection
- Severe heart failure or recent significant cardiovascular events within 6 months
- Active infection requiring intravenous treatment
- HIV positive status
- Pregnant or breastfeeding women
- Evidence of myelodysplasia or related bone marrow abnormalities
- Active hepatitis B or C infection
- History of active CNS disorders like epilepsy or severe brain injuries
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmias, pulmonary or psychiatric conditions limiting compliance
- Autoimmune diseases requiring immunosuppressive medications within 6 months except low dose steroids
- Pre-infusion safety concerns such as active infection, systemic inflammation, recent corticosteroid use, or neurological symptoms
AI-Screening
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Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
P
Paolo Caimi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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