RecruitingPhase 1

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

United States32 participantsStarted 2025-05-06

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).

Number of Participants with Dose-Limiting Toxicities (DLTs)

Timeframe: From Day 0 to Day 28

NCT IDNCT06680037

SponsorTG Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-01

TG Therapeutics Clinical Support Team