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

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT05172596

Run by

Novartis Pharmaceuticals

People needed

146

Starts

2022-03-03

Expected to finish

2025-05-21

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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)
• 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 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

You may not qualify if…

• 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.
• Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to signing informed consent.
• 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.

Where it is running

• Stanford University — Palo Alto, California, United States
• Emory University School of Medicine-Winship Cancer Institute — Atlanta, Georgia, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Fred Hutch Cancer Research — Seattle, Washington, United States
• Novartis Investigative Site — Camperdown, New South Wales, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Salvador, Estado de Bahia, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Calgary, Alberta, Canada
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Poitiers, France
• Novartis Investigative Site — Würzburg, Bavaria, Germany
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Athens, Greece
• Novartis Investigative Site — Thessaloniki, Greece
• Novartis Investigative Site — Ramat Gan, Israel
• Novartis Investigative Site — Tel Aviv, Israel
• Novartis Investigative Site — Bologna, BO, Italy
• Novartis Investigative Site — Milan, MI, Italy

Full record on ClinicalTrials.gov

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