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

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

Plain Language Summary

Simplified for easier understanding

This study tests a new CAR-T cell therapy called azer-cel in people with progressive forms of multiple sclerosis (MS). CAR-T therapy is a treatment where your immune cells are re-engineered to target and eliminate the abnormal immune cells causing MS. **You may be eligible if...** - You have been diagnosed with Primary Progressive or Secondary Progressive MS - You have stopped your current MS disease-modifying medication before enrolling and met the required washout period **You may NOT be eligible if...** - You have had a cancer that has not been in remission for at least 2 years - You have active or chronic hepatitis B, or you are HIV positive - You have previously had a bone marrow, stem cell, or organ transplant - You have previously received CAR-T cell therapy or any gene therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzercabtagene zapreleucel (azer-cel)

IV infusion


Locations(9)

TG Therapeutics Investigational Trial Site

La Jolla, California, United States

TG Therapeutics Investigational Trial Site

Lexington, Kentucky, United States

TG Therapeutics Investigational Trial Site

Ann Arbor, Michigan, United States

TG Therapeutics Investigational Trial Site

Omaha, Nebraska, United States

TG Therapeutics Investigational Trial Site

New York, New York, United States

TG Therapeutics Investigational Trial Site

Rochester, New York, United States

TG Therapeutics Investigational Trial Site

Cleveland, Ohio, United States

TG Therapeutics Investigational Trial Site

Columbus, Ohio, United States

TG Therapeutics Investigational Trial Site

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06680037