LUMT1A22, Phase 1 Study of BAFF CAR T Cells (LMY-920) for Treatment of Relapsed or Refractory Myeloma (LMY-920-002)
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.
• Subjects must have histologically confirmed myeloma relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Failing line of therapy is defined accordingly to International Myeloma Workshop Consensus Panel.
• No evidence of CNS myeloma.
• Male or female \> 18 years of age.
• ECOG Performance status ≤ 2.
• Has measurable disease at the time of enrollment as defined by at least one of the following:
‣ Serum M-protein greater or equal to 0.5g/dL
⁃ Urine M-protein greater or equal to 200mg/24hr
⁃ Serum free light chain (FLC) assay: involved light chain greater or equal to 10mg/dL provided serum FLC ratio is abnormal
⁃ Bone marrow plasma cells greater than or equal to 30% total bone marrow cells
• \>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).
• AST (SGOT)/ALT ≤ 2.5 X institutional upper limit of normal.
• Serum creatinine \< 2 mg/dL.
⁃ Cardiac ejection fraction of \>45%, 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