ASH 2019: Phase Ib/II Study of BCMA-Directed CAR T-Cell Therapy for Pretreated Multiple Myeloma

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Patients with multiple myeloma who had received a median of five prior therapies with refractory disease had a high response rate when treated with the investigational chimeric antigen receptor (CAR) T-cell therapy JNJ-4528, which targets B-cell maturation antigen (BCMA), a protein commonly found on the surface of multiple myeloma cancer cells. Madurri et al presented these results at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 577).

“We are seeing a high response rate, with most patients achieving minimal residual disease (MRD) negativity,” said lead study author Deepu Madduri, MD, of The Tisch Cancer Institute at Mount Sinai. “Considering these patients have all received multiple prior therapies, these results are extremely encouraging.” 

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More About JNJ-4528

"JNJ-4528 is a novel CAR T-cell therapy featuring two molecules that bind to BCMA. “We are learning that every CAR T-cell therapy is different,” said Dr. Madduri. “JNJ-4528 has a unique CAR T-cell composition in patients, preferentially enriched in CD8 T cells, which are believed to be one of the most important T cells in killing cancer cells.”


The phase Ib/II trial—CARTITUDE-1—is continuing to enroll patients. Dr. Madduri reported results for the first 29 patients enrolled. Patients’ T cells were collected and sent to a laboratory where they were genetically engineered to express JNJ-4528. Prior to reinfusing these CAR T cells, the patients received 3 days of chemotherapy. Following chemotherapy, each patient received a single infusion of the JNJ-4528 CAR T cells. They had blood and bone marrow exams at a minimum of 28 days, 6 months, and 1 year after treatment to assess their response. The primary endpoints of the trial are to assess the therapy’s safety and to confirm the dose to be tested in a larger phase II trial.


The median follow-up time in the current analysis is 6 months. Overall, 100% of patients had a clinical response to JNJ-4528. All evaluable patients receiving the CAR T-cell therapy achieved MRD-negative disease state, and 27 of 29 patients were progression-free at a median follow-up of 6 months, Dr. Madduri said. Sixty-six percent of patients had a stringent complete response.

Most patients (93%) experienced cytokine release syndrome; one patient had grade 3 cytokine release syndrome, and one patient died from its complications 99 days after the CAR T-cell infusion. In 76% of patients, cytokine release syndrome was treated with tocilizumab.


  • Overall, 100% of patients had a clinical response to JNJ-4528, and all evaluable patients receiving the CAR T-cell therapy achieved MRD-negative disease state.
  • 27 of 29 patients were progression-free at a median follow-up of 6 months.
  • Most patients (93%) experienced cytokine release syndrome.

“To see some patients in this heavily pretreated population surviving for a year or more with a one-time treatment and a manageable safety profile is remarkable,” said Dr. Madduri. “These patients feel that they have their quality of life back. They no longer have to come into the clinic for weekly treatments, and some are well enough to travel.”

The phase II portion of this study is ongoing to evaluate the overall response rate of patients treated with JNJ-4528. Additional clinical studies are evaluating the safety and efficacy of JNJ-4528 in different multiple myeloma treatment settings.

Disclosure: This study was supported by Janssen Research & Development, LLC. For full disclosures of the study authors, visit

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.