A Phase 2 study of PHE885, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants 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 cell therapy, manufactured with a new process. The CAR-T cell therapy will be
investigated as a single agent in relapsed and refractory multiple myeloma
1. ≥18 years of age at the time of informed consent form (ICF) signature
2. Adult patients after failure of three or more 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
who have documented evidence of disease progression (IMWG criteria) 3, Must have
received ≥2 consecutive cycles of treatment for at least three prior regimens unless
deemed refractory to that regimen (i.e., progressive disease as the best response)
4. Must be refractory to the last treatment regimen (defined as progressive disease on or
within 60 days measured from last dose of last regimen).
5. Measurable disease at enrollment as defined by the protocol 6. Eastern Cooperative
Oncology Group (ECOG) performance status that is either 0 or 1 at screening 7. Must have a
leukapheresis material of non-mobilized cells accepted for manufacturing
1.Prior administration of a genetically modified cellular product including prior BCMA
CAR-T therapy. 2.Participants who have received prior BCMA -directed bi-specific antibodies
or anti-BCMA antibody drug conjugate.
3. Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to signing
4.Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM 5.POEMS
syndrome 6.Active central nervous system (CNS) involvement by malignancy 7.Patients with
active neurological autoimmune or inflammatory disorders 8.Inadequate cardiac, renal,
hepatic or hematologic function as defined in the protocol.
Other protocol-defined Inclusion/Exclusion may apply.