PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, B-cell maturation antigen, BCMA, BCMA-directed, chimeric antigen receptor, CAR-T, PHE885
Eligibility Criteria
Inclusion Criteria:
- ≥18 years of age at the time of informed consent form (ICF) signature
- 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 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 tot hat 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
Exclusion Criteria:
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 informed consent.
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 auto immune or inflammatory disorders
Other protocol-defined Inclusion/Exclusion may apply.
Sites / Locations
- Stanford University .Recruiting
- Emory University School of Medicine/Winship Cancer InstituteRecruiting
- Dana Farber Cancer Institute Main SiteRecruiting
- Oregon Health and Science UnivRecruiting
- Thomas Jefferson University .Recruiting
- Fred Hutch Cancer ResearchRecruiting
- Novartis Investigative SiteRecruiting
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- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Experimental
PHE885
Patients will receive PHE885