A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTG Therapeutics, Inc.

About this trial

The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).

Eligibility criteria

Qualifiers

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.

Disqualifiers

History of malignancy that has not been in remission for at least 2 years.

Viral Screening

Evidence of chronic active or history of hepatitis B virus (HBV).

Seropositive for human immunodeficiency virus (HIV) antibody.

Trial design

Treatments tested in this trial

  • Azercabtagene zapreleucel (azer-cel)

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators