Actively Recruiting
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
Led by TG Therapeutics, Inc. · Updated on 2026-04-07
32
Participants Needed
9
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
CONDITIONS
Official Title
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS
- Participants must have discontinued disease modifying therapy prior to signing the informed consent form
- Participants must meet specific washout criteria before receiving lymphodepletion
You will not qualify if you...
- History of malignancy not in remission for at least 2 years
- Evidence of chronic active or history of hepatitis B virus infection
- Seropositive for human immunodeficiency virus (HIV) antibody
- History of bone marrow, hematopoietic stem cell, or solid organ transplantation
- Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target such as CAR T-cell therapy
- Other protocol-specified inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
TG Therapeutics Investigational Trial Site
La Jolla, California, United States, 92093
Actively Recruiting
2
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, United States, 40506
Not Yet Recruiting
3
TG Therapeutics Investigational Trial Site
Ann Arbor, Michigan, United States, 48019
Actively Recruiting
4
TG Therapeutics Investigational Trial Site
Omaha, Nebraska, United States, 68198
Actively Recruiting
5
TG Therapeutics Investigational Trial Site
New York, New York, United States, 10025
Actively Recruiting
6
TG Therapeutics Investigational Trial Site
Rochester, New York, United States, 14642
Actively Recruiting
7
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
TG Therapeutics Investigational Trial Site
Columbus, Ohio, United States, 43210
Actively Recruiting
9
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
T
TG Therapeutics Clinical Support Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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