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

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Trial ID: NCT05172596

Purpose

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

Official Title

A Phase 2 Study of PHE885, B-cell Maturation Antigen (BCMA)- Directed CAR-T Cells in Adult Participants With Relapsed and Refractory Multiple Myeloma.

Stanford Investigator(s)

Surbhi Sidana, MD
Surbhi Sidana, MD

Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Eligibility


Inclusion Criteria:

   1. ≥18 years of age at the time of informed consent form (ICF) signature

   2. 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:

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.

Intervention(s):

biological: PHE885

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kristin Ana-Marie Muller
kmuller1@stanford.edu

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