Actively Recruiting
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma
Led by Luminary Therapeutics · Updated on 2024-10-21
20
Participants Needed
2
Research Sites
93 weeks
Total Duration
On this page
Sponsors
L
Luminary Therapeutics
Lead Sponsor
C
Case Comprehensive Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
CONDITIONS
Official Title
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or refractory to chemotherapy
- No evidence of central nervous system lymphoma
- Male or female 18 years of age or older
- Eastern Cooperative Oncology Group Performance status 2 or less
- At least one measurable lesion
- More than 2 weeks since prior radiation or systemic therapy at leukapheresis
- Total bilirubin 1.5 mg/dL or less (except Gilbert's syndrome)
- Aspartate aminotransferase/alanine transferase 2.5 times or less institutional upper limit of normal
- Serum creatinine less than 1.5 mg/dL
- Cardiac ejection fraction over 50% with no pericardial effusion
- Adequate pulmonary function with pulse oximetry 92% or higher on room air
- Ability to understand and sign written informed consent
- Women of childbearing potential must agree to abstinence or effective contraception during treatment and 90 days after infusion
- Men must agree to abstinence or contraception and to refrain from donating sperm
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 central nervous system or meningeal lymphoma or leukemia involvement
- 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
- Recent serious cardiovascular events within 6 months
- Active infection requiring intravenous treatment
- HIV positive status
- Pregnant or breastfeeding women
- Evidence of myelodysplasia or cytogenetic abnormalities before therapy
- Active hepatitis B or C infection
- History of significant central nervous system disorders such as epilepsy, seizure disorders, stroke, severe brain injuries, dementia, or Parkinson's disease
- Uncontrolled intercurrent illness
- Additional malignancies requiring systemic treatment
- Autoimmune disease requiring immunosuppressive medications (other than low dose steroids) within 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
2
Taussig Cancer Institute | Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
P
Paolo F. 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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