Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06680037

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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