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Publication Number
US-12109234-B2
Publication Date
2024-10-08
Expiration Date
Abstract
The invention provides improved anti-BCMA CAR T cell compositions for adoptive T cell therapy for relapsed/refractory multiple myeloma.
Core Innovation
The disclosure describes a method of treating relapsed or refractory multiple myeloma in a human subject. The method comprises administering intravenously a single dose of a pharmaceutical composition comprising anti-human B cell maturation antigen chimeric antigen receptor human T cells, and the treated population includes a human subject who has received at least 2 prior treatment regimens including a proteosome inhibitor and an immunomodulatory agent.
The core CAR composition is defined by an anti-BCMA CAR that comprises amino acids 22-493 of the amino acid sequence of SEQ ID NO: 9. The dosing is therapeutically effective and is independent of bone marrow disease in the subject, with embodiments specifying dose thresholds between greater than 45.0×10^7 and less than 80.0×10^7 cells or a defined proportion of anti-human BCMA CAR T cells.
The disclosure further describes an anti-BCMA CAR design domain set and CAR human T cell preparation. The components include an anti-BCMA CAR with a signal peptide, an anti-BCMA scFv defined by CDRs corresponding to SEQ ID NOs: 1-8, and a CD8a hinge and transmembrane domain, together with a 4-1BB/CD137 co-stimulatory domain and a CD3ζ primary signaling domain.
Claims Coverage
The partial claim set includes two independent claims. Each independent claim is centered on a single-dose intravenous method for RRMM using an anti-BCMA CAR human T cell product defined by amino acids 22-493 of SEQ ID NO: 9, with dose ranges or dose proportion and independence from bone marrow disease status.
Single-dose intravenous anti-BCMA CAR T cell treatment with a dose range independent of bone marrow disease
A method of treating RRMM in a human subject who has received at least 2 prior treatment regimens including a proteosome inhibitor and an immunomodulatory agent, comprising administering intravenously to the subject a single dose of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and anti-human BCMA CAR human T cells, wherein the dose is greater than 45.0×10^7 and less than 80.0×10^7 anti-BCMA CAR T cells, wherein the anti-BCMA CAR comprises amino acids 22-493 of the amino acid sequence of SEQ ID NO: 9, and wherein the dose is independent of bone marrow disease in the subject.
Single-dose intravenous anti-BCMA CAR T cell treatment with a defined dose and defined fraction independent of bone marrow disease
A method of treating RRMM in a human subject who has received at least 2 prior treatment regimens including a proteosome inhibitor and an immunomodulatory agent, comprising administering intravenously to the subject a single dose of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and anti-human BCMA CAR human T cells, wherein the dose is 45.0×10^7 to 120% anti-human BCMA CAR T cells, wherein the anti-BCMA CAR comprises amino acids 22-493 of the amino acid sequence of SEQ ID NO: 9, and wherein the dose is independent of bone marrow disease in the subject.
Across both independent claims, the coverage concentrates on intravenous single-dose anti-BCMA CAR human T cell therapy for RRMM after at least two prior regimens that include a proteosome inhibitor and an immunomodulatory agent. The anti-BCMA CAR is defined by amino acids 22-493 of SEQ ID NO: 9, and the dosing limitation and independence from bone marrow disease status define the key inventive boundaries.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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