Please note that some study locations are now accepting new study participants, however some locations remain closed due to the ongoing impact of Coronavirus (COVID-19). Please continue to check back as we expect to add more study locations as this situation improves and changes.
In order to qualify for the TRANSFORM Study, certain criteria must be met. Some of the basic criteria are listed below.
Other criteria must be met to participate. A study doctor will need to perform various health tests and examinations to confirm if you are able to participate in the TRANSFORM Study.
If you meet these initial criteria, we invite you to take the prescreening questionnaire below to see if you may qualify to participate in this study.
Health insurance is not required to participate.
You will first need to take part in a screening visit for a series of medical tests to determine whether you qualify for the study. The visit will include disease assessment, blood and urine sample testing, a physical exam, questions about your health and treatments, and a full review of your medical history. If you qualify and agree to participate, you will be entered into the study.
If you qualify and agree to participate, you will be asked to follow instructions of the study doctor. Your participation is expected to last up to three years. Below is a breakout of the different stages of the TRANSFORM Study.
If you join the TRANSFORM Study, it will be important for you to keep in communication with the study team and to ask questions. Treatments for cancer and for side effects can be complicated, so be sure to talk openly about your disease, your overall health, and what treatment options may be best for you at any time. The study doctor and team want you to be informed and are available to support you throughout your participation and study treatment.
Remember, you can choose to leave the study at any time for any reason, without penalty to you.
JCAR017 is known as a Chimeric Antigen Receptor T cell, or CAR-T cell therapy. This involves taking T-cells from your body, modifying them in a laboratory, then injecting them back into your body. These modified cells may have the potential to recognize, target, and destroy the mutated B-cells.
You will be asked to undergo lymphodepleting chemotherapy before the modified cells are injected back into your body.
You will receive study treatment at no cost.
There are risks and benefits of taking part in any clinical research study. For example, you may benefit from the frequent health checks. You may also benefit from taking the investigational study drug, although this cannot be guaranteed. Your health may get better, it may stay the same, or it may get worse. You should discuss the risks and benefits of participation with your health care providers. These risk and benefits are also outlined in detail in the informed consent form (ICF) that you must read and sign before you can take part in the study.
Study treatment will be provided at no cost. You may be reimbursed for reasonable travel expenses as long as relevant receipts are provided.