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

Description

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

Conditions

B-cell Mediated Autoimmune Disorders

Study Overview

Study Details

Study overview

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

A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders

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

Condition
B-cell Mediated Autoimmune Disorders
Intervention / Treatment

-

Contacts and Locations

Lexington

TG Therapeutics Investigational Trial Site, Lexington, Kentucky, United States, 40506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
  • 2. Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.
  • 1. History of malignancy that has not been in remission for at least 2 years.
  • 2. Viral Screening
  • 1. Evidence of chronic active or history of hepatitis B virus (HBV).
  • 2. Seropositive for human immunodeficiency virus (HIV) antibody.
  • 3. History of bone marrow/hematopoietic stem cell or solid organ transplantation.
  • 4. Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

TG Therapeutics, Inc.,

Study Record Dates

2029-01-01