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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05172596.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Name Not Available
This clinical trial employs an open label, single arm, multi-center design with primary
analysis testing overall response rate ( ORR), including one interim analysis for
futility and one interim analysis for efficacy.
The trial population includes adult patients with relapsed and refractory multiple
myeloma (MM) after failure of 3 or more lines of therapy, including failing an
immunomodulatory drug (IMiD), a proteasome inhibitor (PI) and an anti-CD38 (cluster of
differentiation 38) monoclonal antibody (mAb) and who have measurable disease at
enrollment per IMWG criteria . In addition, patients must be refractory to the last line
of therapy
The trial will enroll 90 efficacy evaluable adult patients with relapsed and refractory
MM (efficacy evaluable means participants infused with a PHE885 product at target dose
10e6 that met all release specifications).
Patients will be followed for acute and intermediate safety and efficacy within this
trial for a minimum of 2 years before being transferred to the long-term follow-up trial.
A long-term post-study follow-up for lentiviral vector safety will be offered under a
separate destination protocol for 15 years post injection per health authority
guidelines.
Lead OrganizationNovartis Pharmaceuticals Corporation