NCT06680037
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
Recruiting · Phase 1 · TG Therapeutics, Inc. · registry updated 2026-10-27
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Inclusion
- PMS and RMS inclusion criteria:
- Age 18 years to ≤60 years (inclusive) at screening.
- Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
- Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).
- Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit.
- Willingness and ability to undergo lumbar puncture (LP) for cerebrospinal fluid (CSF) collection at protocol-specified timepoints, with no contraindications to the procedure in the opinion of the Investigator.
Exclusion
- History of malignancy that has not been in remission for at least 2 years.
- Active venous thromboembolism (e.g., deep vein thrombosis or pulmonary embolism), clinically significant coagulopathy (e.g., disseminated intravascular coagulation), or current therapeutic anticoagulation (e.g., warfarin).
- Viral and Tuberculosis (TB) Screening
- Evidence of chronic active or history of hepatitis B virus (HBV).
- Seropositive for human immunodeficiency virus (HIV) antibody.
- History of bone marrow/hematopoietic stem cell or solid organ transplantation.