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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)
  • 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)
  • 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-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
  • POEMS syndrome
  • Active central nervous system (CNS) involvement by malignancy
  • Patients with active neurological auto immune or inflammatory disorders
  • Inadequate cardiac, renal, hepatic or hematologic function as defined in the protocol.

Other protocol-defined Inclusion/Exclusion may apply.

Additional Trial Information

Phase 2

Enrollment: 136 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Stanford Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Open and Accepting
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