The main purpose of this study is to evaluate the safety of an investigational CAR-T cell therapy called Descartes-08. The study will also explore whether Descartes-08 provides any treatment benefit in patients with Multiple Myeloma.
If you choose to participate and qualify, Descartes-08 will be custom-made for you from your own blood cells. Descartes-08 cells are CAR-T cells, which are T-cells that have been modified to attack myeloma (tumor) cells. To modify the cells, the Sponsor inserts new instructions into the T-cells. These instructions cause the cells to produce a new piece of cellular machinery called a CAR (Chimeric Antigen Receptor). The CAR in Descartes-08 causes T-cells to kill other cells that carry a marker called BCMA. Because the BCMA marker is present on myeloma cells, it is hoped that Decartes-08 will destroy the myeloma cells without harming most other cell types. However, the BCMA marker is not unique to myeloma cells. Plasma cells, whose role is to protect you from certain kinds of infection, also produce BCMA. Descartes-08 could have an unwanted effect on these cells.
If you choose to participate and qualify for this study, T-cells will be collected from your blood with equipment called an apheresis machine. Your T-cells will be sent to a special laboratory where they will be processed into Descartes-08 cells and quality-tested. If the cells meet all quality standards, they will be sent back to your clinic. Normally, production of Descartes-08 cells will take about one to two weeks.
The scheduled procedures for this study will occur in the outpatient clinic.
Once your Descartes-08 cells arrive at the clinic, they will be kept in the freezer. Before you can receive the Descartes-08 cells, you will receive three days of chemotherapy. This consists of two FDA-approved medicines called fludarabine and cyclophosphamide. It is hoped that the chemotherapy will improve the activity of the Descartes-08 cells.
Two days after the chemotherapy, after meeting pre-determined laboratory criteria, Descartes-08 will be infused into your bloodstream. You will receive Descartes-08 in multiple doses over a week. During that time, you will be monitored for any adverse reactions.
Your participation in this study will last about 12 months but could be shorter. About 15 people will participate. The study will be run at several study clinics.
The following is a visit-by-visit description of what you are expected to do.
The Descartes-08 cells that have been prepared for you will then be administered into your bloodstream (infused).
It is expected to take about 15-30 minutes to infuse the Descartes-08 cells into your bloodstream. You will have to remain in the clinic for up to 4 hours after you receive the Descartes-08 cells. During this time the clinic personnel will monitor you.
You will return to the clinic over the first week to receive repeat doses of Descartes-08.
After this visit, the study doctor will review the results of your tests. If your Multiple Myeloma has progressed (worsened) during the trial, you will be removed from the clinical trial. Your study doctor will speak with you about your treatment options.
At any of these visits, depending on the status of your Multiple Myeloma, your study doctor may continue to observe you without additional treatment, or may discuss with you other treatment options.
Your participation in the study will end at the 12-month visit or earlier if you withdraw from the study or the study doctor withdraws you. The study doctor can withdraw you at any time if you fail to show up for study visits or follow study instructions, or if the study doctor thinks withdrawal is necessary for your health or safety (or if you become pregnant). Your withdrawal would not require your consent, but you would be informed of this decision and the reason.
You are free to leave the study at any time. Withdrawal will not interfere with your future care. If you decide not to continue with the study, tell the study doctor. The study doctor may still recommend tests or a follow-up visit to monitor your health.
The Sponsor is providing reimbursement for travel and accommodation. Please contact study staff for details.
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.
Inclusion Criteria (condensed):
Exclusion Criteria (condensed):
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
Oklahoma City, OK
Oklahoma City, OK
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