A Study Of JNJ-68284528, A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) In Participants With Multiple Myeloma

Overview

About this study

The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Cohort A:
    • Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines.
  • Cohort B:
    • Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria ≤ 12 months after treatment with autologous stem cell transplantation (ASCT) or ≤ 12 months from the start of anti-myeloma therapy for participants who have not had an ASCT.
  • Cohort C:
    • Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy.
  • Cohort D:
    • Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation.
  • Cohort E:
    • Have newly diagnosed multiple myeloma without prior therapy and classified as high risk per International Staging System (ISS) stage III criteria, defined as: beta 2 microglobulin greater than (>) 5.5 milligram per litre (mg/L).
  • Cohort A, B, C, E:
    • Serum monoclonal paraprotein (M-protein) level ≥ 1.0 gram per deciliter (g/dL) or urine M-protein level ≥ 200 milligram (mg)/24 hours.
    • Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
  • Cohort A, B, C:
    • For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria.
  • Cohort A, B, C, D, E:
    • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.

Exclusion Criteria:

  • Cohort A, B, D:
    • Any therapy that is targeted to BCMA.
  • Cohort A, B, C, D:
    • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target.
    • Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
    • Received a cumulative dose of corticosteroids equivalent to ≥ 70 mg of prednisone within the 7 days (Cohort A, B, C) or 14 days (Cohort D) prior to apheresis.
    • Serious underlying medical condition, such as:
      • Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection.
      • Active autoimmune disease or a history of autoimmune disease within 3 years.
      • Overt clinical evidence of dementia or altered mental status.
      • Any history of Parkinson's disease or other neurodegenerative disorder.
  • Cohort A, B, C, D, E:
    • Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yi Lin, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20520963

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