This is an investigational study of CAR2 Anti-CD38 A2 CAR-T Cells in patients with Relapsed or Refractory Multiple Myeloma. The treatment uses your own T cells to try to kill your cancerous multiple myeloma cells. T cells fight infections and can also kill cancer cells in some cases. In this study, some of your T cells will be removed from your blood by a process called leukapheresis, changed in a laboratory, and then given back to you by intravenous (IV) infusion. While your T cells are in the laboratory, new genetic material will be put into your T cells. If your genetically changed T cells recognize and attach to multiple myeloma cells, the T cells may have the ability to become activated and kill the multiple myeloma cells.
The aim of this study is to find out:
If you meet all the criteria for being in the study, you will be entered into the study. The study is divided into the following 3 Periods: Screening, Treatment, and Observation.
Screening: The Screening Period is scheduled to take place within up to 43 days prior to receiving the study therapy and will includes the T cell collection visit. If the tests performed during the Screening Period show that you can take part in this study and your T cells grow in the laboratory so that there is an adequate number of cells available to give you an appropriate dose of study therapy, you will receive the dose of study therapy in 3 divided intravenous infusions.
Treatment: On Day 1 of the Treatment Period you will receive 10% of the dose, on Day 2 you will receive 30% of the dose, and on Day 3 you will receive 60% of the dose of study therapy. Each intravenous infusion will occur over 15 to 60 minutes. You may receive pre-medications such as Tylenol and Benadryl to help prevent a reaction to the infusion. After receiving the study therapy, you will be required to stay near to the hospital for the duration of the Treatment Period (Days 1 to 28 of the Treatment Period) to ensure rapid identification and rapid treatment of any side effects that you may experience that occur following the infusion of study therapy. You will be required to return for visits throughout the rest of the 28 day Treatment Period to be followed for safety and to perform further tests and procedures.
Observation: You will also be required to return for additional safety follow-up visits and procedures every 28 days for 5 months following the completion of the Treatment Period.
Long Term Follow-up: You will be asked to enroll into a long-term safety observation study at the End of Study visit or at your last study visit if you discontinue the study prior to the end of the Observation Period. All patients who have received modified T cell therapy regardless of the dose received will be contacted at least annually for follow-up. This follow-up visit may be by a clinic visit or by a telephone call. You will be asked about your general health and your multiple myeloma. The visit schedule for this long-term safety observation study will be every 2 months for 2 visits after the End of Study visit, then every 6 months up to year 5, and then yearly up to year 15.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
The following is a listing of trial locations that are open and accepting patients.