The purpose of this study is to find out how safe and effective a new CAR-T study treatment, called MB-105, is for people with T-cell lymphoma. MB-105 is an experimental study treatment. This means it is not approved for general use by the U.S. Food and Drug Administration (FDA) and, as such, can only be used in research studies.
Your participation in this study includes the time from which you sign the consent form, through the completion of the 24 month follow up. During this time, you will need to visit the study clinic on a regular basis for study treatment, tests and exams. The study has five key time periods: • Screening: many tests during screening are repeated during study time periods and would be part of your standard cancer treatment. A biopsy will be performed during screening if tissue is not already available. • Creation of MB-105 (manufacturing): a blood collection procedure called apheresis will occur in order to make your MB-105. • Study Treatment: this includes conditioning therapy (administration of chemotherapy agents Cyclophosphamide and Fludarabine), anti-viral therapy (administration of anti-viral medicine Rituximab), and MB-105 study treatment. • Post-dose Safety monitoring: 4-week period after the MB-105 infusion for safety assessments. • Follow-up period: you will be checked on regularly in the 24 months after your MB-105 IV infusion. After the 24-month follow-up period, we will ask you to join another study. In this 'long-term follow-up' study we would like to monitor you regularly for up to 15 years. This will involve us contacting you every year to see how you are managing. You do not have to join the 15-year follow-up study to be part of this study.
If you have to travel far to the study clinic, we may help to pay for travel, food, and hotel costs.
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Anne Beaven
LCCC - Clinical Trials
Clinical or Medical
Interventional
Cancer (Lymphoma)
24-2095