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

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

ClinicalTrials.gov Identifier: NCT05172596

Novartis Reference Number: CPHE885B12201

Last Update: Apr 20, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Multiple Myeloma
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Mar 07, 2022
Completion date 
Jul 17, 2025
Gender 
All
Age(s)
25 Years and older (Adult, Older Adult)

Interventions

Biological
PHE885
Intravenous injection (IV) injection

Eligibility Criteria

Inclusion Criteria:

≥18 years of age at the time of informed consent form (ICF) signature
Adult 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

Exclusion Criteria:

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 Locations

Australia
Novartis Investigative Site
Recruiting
VIC, 3004
Melbourne
Australia
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]