LMY-920 for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
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.
• Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT).
• No evidence of central nervous system (CNS) lymphoma.
• Male or female \> 18 years of age.
• Eastern Cooperative Oncology Group Performance status ≤ 2.
• At least one measurable lesion.
• \>2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.
• Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome).
• Aspartate aminotransferase/alanine transferase ≤ 2.5 X institutional upper limit of normal.
• Serum creatinine \< 1.5 mg/dL.
⁃ Cardiac ejection fraction of \>50%, and no evidence of pericardial effusion, as determined by an echocardiogram.
⁃ Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
⁃ Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
⁃ For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.
⁃ For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.