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

RECRUITINGPhase 1Sponsored by TG Therapeutics, Inc.

Actively Recruiting

PhasePhase 1

SponsorTG Therapeutics, Inc.

Started2025-05-06

Est. completion2026-12-01

Eligibility

Age18 Years+

Healthy vol.Accepted

Locations8 sites

View on ClinicalTrials.gov →

NCT06680037

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted

Inclusion 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.

Exclusion Criteria:

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).

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.