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

Overview

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.

SparkCures ID 1234
Trial Phase Phase 2
Enrollment 136 Patients
Treatments
Tags
Trial Sponsors
  • Novartis
NCT Identifier

NCT05172596

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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