TNB-383B is a bi-specific antibody, meaning that it interacts with two molecules in your body. One molecule is called B-Cell Maturation Antigen (BCMA) and is found on your multiple myeloma cells. The second is called CD3 and is present on your killer T-cells. When CD3 is engaged on a T cell, it turns the T-cell on and makes it kill whatever cell triggered the activation. Because TNB-383B sticks very strongly to the BCMA on your myeloma cells, nearby T-cells should specifically attack your tumor cells.
This study is open-label, meaning that everyone on the study will receive TNB-383B. It is a Phase 1, First-in-Human trial, meaning that it is the first study where TNB-383B will be given to human patients. TNB-383B is an investigational agent, meaning that it is still being tested for safety and efficacy and has not yet been approved by the FDA.
The purpose of the Study is:
The study is divided into two parts. Part 1 of the Study will be conducted with approximately 24 participants at about 6 sites in the United States.
This first part will test different and increasing doses of TNB-383B. In Part 1 of the study, called the “dose escalation phase”, approximately 9 different, increasing doses of TNB-383B will be tested. TNB-383B is a medication that is given to you in the doctor’s office by an intravenous injection(IV, which means in the arm vein or central line). Each dose of TNB-383B will be assigned to a separate group of 1-6 participants. If the group assigned to the first dose level tolerates TNB-383B without serious side effects, then the next group will be assigned an increased dose of TNB-383B. This will continue until pre-determined and/or significant side effects are seen or the highest planned dose has been tested. The Sponsor will then stop the dose escalation part of the Study and move into the next part of the study, called the “expansion” phase.
The total number of patients enrolled in both arms of the study is anticipated to be approximately 72 subjects. This includes approximately 24 patients in the dose escalation arm and approximately 48 patients in the dose expansion arm of the study,
TNB-383B is a medication that is given to you in the doctor’s office by an intravenous injection(IV, which means in the arm vein or central line). After the first dose, a patient receiving TNB-383B must stay in the hospital for 48 hours to let the doctors observe them for any reaction they might have to the drug.
Your time in this research study will be followed in cycles. One cycle is 21 days (3 weeks) in duration. The duration of participation in this study may be different for each participant. For most participants, the screening will take up to 28 days to determine if you meet all of the criteria for study participation, called eligibility. If you are eligible to participate in this study, you will be enrolled and receive TNB-383B once every three weeks. Study participants will be given TNB-383B and carefully monitored for as long as your myeloma is not growing, you do not have any unacceptable side effects, and you do not decide to withdraw from the study.
This study includes four periods:
If at any point you become unwell during the study, either from your myeloma, another illness/injury, or from side effects of your medications, it may require additional, unscheduled visits or possibly even a hospital admission. Your safety and well-being are our first priority so you may be asked to come in for an office visit or be admitted to the hospital at a lower threshold than you are used to while not receiving an investigational agent. You are always encouraged to let your Study doctor know if you have concerns or are feeling unwell. Nevertheless, your Study doctor will also strive to minimize inconvenience and disruption for you.
If your myeloma gets worse despite treatment with TNB-383B, or if you have a bad reaction to TNB-383B that the doctors cannot effectively treat, TNB-383B will likely be stopped. However, your Study doctor or nurse will continue to check in via telephone with you every 3 months to see how you are doing.
Study visits and evaluations will be performed at Screening and at Day 1 of each Cycle. Based on a 3- week cycle, additional study visits and evaluations will be performed on Days 2, 3, 8, and 15 during the first Cycle, on Day 15 only in Cycles 2 and 3, and on Days 2, 8, and 15 in Cycle 6.
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.
You may be eligible to participate in this study if you:
The following is a listing of trial locations that are open and accepting patients.