PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma

Trial number:
Trial phase:
Study type:
Targeted therapy
Overall status:

Study start date

March, 2022

Scientific title

Phase II, Open Label, Study of PHE885, a B-cell Maturation Antigen (BCMA)-Directed CAR-T Cells in Adult Patients With Relapsed and Refractory Multiple Myeloma


This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed CAR-T cells, manufactured with a new process. CAR-T cells will be investigated as a single agent in relapsed and refractory multiple myeloma

≥18 years of age at the time of informed consent form (ICF) signatureAdult patients with relapsed and refractory multiple myeloma who have received at least 3 prior lines of therapy including an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab), and have documented evidence of disease progression (IMWG criteria) Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen). Measurable disease at enrollment as defined by the protocol Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Participants who have received prior BCMA -directed bi-speciific antibodies or anti-BCMA antibody drug conjugate.Prior allogenic stem cell transplantation (SCT) at any time or autologous SCT within 3 months prior to signing informed consent Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM POEMS syndrome Active central nervous system (CNS) involvement by malignancy Patients with active neurological auto immune or inflammatory disorders

Other protocol-defined Inclusion/Exclusion may apply.

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Masking: None (Open Label),


Multiple Myeloma

Other study ID numbers

CPHE885B12201; 2021-003747-22

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