IRB Study Number 25-275
Status Recruiting
Phase Phase 1
Location U Building - Mellen Center
Institute Neurological Institute
Description
The purpose of this study is to learn more about the safety and tolerability of azercabtagene zapreleucel (azer-cel) given to individuals who have been diagnosed with certain B-cell mediated autoimmune disorders, including either primary or secondary progressive multiple sclerosis (PMS). All participants will be given the study drug, there is no randomization (assignment by chance) to a placebo.
Azer-cel is an investigational drug made from a type of blood cell known as T cells. The T cells in azer-cel are from healthy people who have donated their blood. The donated T cells have been genetically changed so that they are able to target and eliminate a specific type of white blood cell, called B cells, that are involved in diseases like PMS, where the body's immune system attacks its own cells. It is not approved by the Food and Drug Administration (FDA).
You will be asked to visit the study center several times throughout the study, which has a duration of approximately 2 years.
Activities include screening tests and procedures, study therapies as well as lymphodepletion chemotherapy, and study drug infusion during inpatient hospital stay. Assessments, questionnaires, sample collections (including lumbar punctures), recordings, scans, etc. will be completed.
Inclusion Criteria
- Age 18-60 years
- Diagnosed with progressive multiple sclerosis (PMS)
- EDSS 3.0-6.5
- Discontinued disease modifying therapy (DMT) and met washout criteria
Exclusion Criteria
- History of malignancy not in remission for 2 years
- Evidence of chronic active or history of hepatitis B virus (HBV)
- HIV seropositive
- History of bone marrow/hematopoietic stem cell or organ transplantation
- Prior adoptive T-cell or gene therapy
