PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
About the study
Who can take part
INCLUSION 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 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
EXCLUSION CRITERIA
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 autoimmune or inflammatory disorders 8.Inadequate cardiac, renal, hepatic or hematologic function as defined in the protocol.
Other protocol-defined Inclusion/Exclusion may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Study’s details
Contition
Multiple Myeloma
Age (in years)
18+
Phase
Phase 2
Participants needed
136
Est. Completion Date
Dec 16, 2025
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT05172596
Study number
CPHE885B12201
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?