RecruitingPhase 1NCT06680037

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

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

Sponsor

TG Therapeutics, Inc.

Enrollment

32 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

B-cell Mediated Autoimmune Disorders

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.

Exclusion Criteria6

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.
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 (e.g. CAR T-cell therapy).