Learn more about a phase 3 clinical research study called the TRANSFORM Study, for people with high risk, aggressive B-cell non-Hodgkin lymphomas
About this study
In non-Hodgkin lymphoma (NHL), the T-cells (whose job it is to destroy abnormal cells in the body) are unable to recognize cancerous B-cells, and so these are not destroyed. The TRANSFORM Study is testing an investigational study drug called JCAR017 and comparing it to existing treatments for aggressive B-cell NHL.
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. TRANSFORM Study participants will need to undergo chemotherapy, called lymphodepleting chemotherapy, prior to the modified cells being injected back into their bodies. This is to reduce the number of other immune cells and give the modified cells a better chance to spread to where they are needed.
Not all participants will receive CAR-T cell therapy at the start of the study. Some participants will receive the current standard of care – however if their disease worsens or does not respond as expected, they may receive JCAR017 (CAR-T). You will not know which group you will be assigned until after you qualify and enroll in the study. You have an equal chance of being placed into either study group.
About Non-Hodgkin Lymphoma (NHL)
Non-Hodgkin lymphomas are cancers that start in the lymphatic system. The lymphatic system is a network of tissues and cells that help the body remove toxins, waste, and other unwanted materials. The system transports a fluid called “lymph” that contains white blood cells called B-cells and T-cells throughout the body, which are used to fight infections. The tonsils, lymph nodes, thymus, and spleen are some of the organs in this system.
In most cases it is not known what causes NHL, but it starts when the body makes too many abnormal lymphocytes that do not work as they should. These abnormal cells continue to grow and spread, causing crowding in the lymph nodes, causing swelling and damage to healthy cells.
Symptoms of NHL can include:
- Painless, swollen lymph nodes in the neck, armpits, or groin
- Abnormal pain or swelling
- Chest pain, coughing and/or trouble breathing
- Extreme tiredness
- Fever
- Night sweats
- Unexpected weight loss
How is NHL treated?
Once NHL is diagnosed by a doctor, depending on what type it is and how far it has developed, a doctor will recommend different treatments. In most cases, various cancer specialists will work together with the patient to determine the best options available. The main treatments for NHL are:
- Chemotherapy: A drug treatment that uses a combination of chemicals to kill fast-growing cells in the body. There are many different kinds of chemotherapy, and more than one type may be used at a time.
- Radiation Therapy: The use of intense energy beams (often x-rays) to kill cancer cells.
- Monoclonal Antibodies: These are proteins that recognize and attach to specific proteins of cancer cells. These antibodies attach to damaged cells, helping the body’s immune system detect and destroy them, or can inject toxins directly into the damaged cells to help kill them.
- Immunotherapy: Also called biologic therapy, helps boost the body’s natural defense to fight cancer. It can include the monoclonal treatments above and CAR-T therapy, such as what the TRANSFORM Study is currently testing.
- Stem Cell/Bone Marrow Transplant: Stem cells are collected from a donor and injected into the patient. This is seen as an aggressive treatment, generally used only with cases of NHL that have progressed significantly or that keeps coming back. In an autologous stem cell transplant, your own blood-forming stem cells are collected.
Frequently asked questions
How can I participate in this study?
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.
What will I be asked to do?
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.
- Pre-Treatment:
- You will undergo a series of tests to check if you qualify for the study.
- You will be randomly assigned (by chance) to receive either standard of care or JCAR017 at the start of the study.
- Treatment:
- You will be randomly (by chance) assigned to one of two treatment groups below:
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- Arm A: Standard of Care (whatever your doctor feels is the best treatment for you that has already been approved and defined in the study protocol)
- Arm B: Investigational study drug JCAR017 infusion, following intravenous (IV) lymphodepleting chemotherapy
- Post-Treatment:
- Your study doctor will continue to follow up with you. The visit schedule for follow-up will depend on which group you were assigned and if/when you may have crossed over from Arm A (standard of care) to Arm B (investigational study drug).
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.
What is the study drug?
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.
Is there any cost to participate?
You will receive study treatment at no cost.
What are the risks and benefits of taking part?
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.