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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

Trial Status: Active

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

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 less than or equal to (<=) 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 greater than or equal to (>=) 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 (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) 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

California

San Francisco
UCSF Medical Center-Parnassus
Status: ACTIVE
Contact: UCSF
Phone: 877-827-3222

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Chelsea Young
Phone: 317-278-5621

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: WITHDRAWN

Multiple myeloma is characterized by the production of monoclonal immunoglobulin (Ig)

proteins or protein fragments (M proteins) that have lost their function. The main aim of the

study is to determine the safety and efficacy of JNJ-68284528 in various clinical settings.

JNJ-68284528 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets

B-cell maturation antigen (BCMA). The study comprises of a Screening Phase (less than or

equal to [<=] 28 days prior to apheresis) followed by Apheresis (will occur upon enrollment);

a Treatment Phase including a conditioning regimen followed by infusion of JNJ-68284528 and

post-infusion assessments from Day 1 to Day 100 (participants who receive an infusion of

JNJ-68284528 should continue all subsequent assessments); and a Post-treatment Phase (Day 101

and up to the end of each study cohort). Safety evaluations will include a review of adverse

events, laboratory test results, vital sign measurements, physical examination findings

(including neurologic examination), assessment of cardiac function, immune effector

cell-associated encephalopathy (ICE) score, handwriting assessment, and assessment of Eastern

Cooperative Oncology Group (ECOG) performance status grade. Efficacy evaluations will include

measurements of tumor burden/residual disease, myeloma proteins, bone marrow examinations,

skeletal surveys, extramedullary plasmacytomas, and serum calcium corrected for albumin. For

certain participants (those without measurable disease in serum or urine) efficacy will be

assessed via imaging: positron emission tomography/ computed tomography (PET/CT) or whole

body magnetic resonance imaging (MRI). The overall duration of the study is up to 2.5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Janssen Research & Development, LLC

  • Primary ID CR108581
  • Secondary IDs NCI-2019-07363, 68284528MMY2003, 2018-004124-10
  • Clinicaltrials.gov ID NCT04133636