A Phase II Study of JNJ-68284528 CAR T-Cell Therapy to Treat Multiple Myeloma

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Full Title

A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)

Purpose

CAR T-cell therapy is a type of immunotherapy. During CAR T-cell therapy, a patient’s own T cells (a type of white blood cell) are removed and genetically modified in the laboratory to recognize a protein on their cancer cells. The modified T cells are multiplied in the lab and returned to the patient to find and destroy cancer cells. 

In this study, researchers are evaluating the effectiveness of a CAR T-cell therapy called JNJ-68284528 (Cilta-cel) in patients with multiple myeloma that has come back or continued to grow despite initial treatment. JNJ-68284528 recognizes a protein on most multiple myeloma cells called BCMA. Patients whose multiple myeloma remains after autologous stem cell transplantation will receive lenalidomide in addition to JNJ-68284528.

Eligibility

To be eligible for this study, patients must meet several criteria (which vary depending on their treatment history), including but not limited to the following:

  • Patients must have multiple myeloma that came back or persists despite prior treatment.
  • Patients should recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

 

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Alexander Lesokhin at 646-608-3717.

Protocol

21-009

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators