BCMA-directed CAR-T Cell Therapy in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Mar 6, 2024
  • participants needed
    48
  • sponsor
    Novartis Pharmaceuticals
Updated on 23 April 2022
measurable disease
lenalidomide
bortezomib
carfilzomib
daratumumab
refractory multiple myeloma
pomalidomide
immunomodulatory imide drug
bcma

Summary

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as a single agent in relapsed/refractory multiple myeloma

Details
Condition Multiple Myeloma
Treatment PHE885
Clinical Study IdentifierNCT04318327
SponsorNovartis Pharmaceuticals
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects with MM who are relapsed and/or refractory to at least 2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (IMWG criteria)
Measurable disease as defined by the protocol
ECOG performance status that is either 0 or 1 at screening
Adequate hematological values
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. Patients who have received prior BCMA-directed bi-specific antibodies or antibody-drug conjugates (ADC) are not excluded
Autologous HSCT within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (HSCT)
Chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (LD) chemotherapy) within 2 weeks prior to apheresis
Treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter
Have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. Daratumumab within 3 weeks prior to apheresis collection
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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