Azer-cel for Autoimmune Disease

Recruiting at 1 trial location

Overseen By TG Therapeutics Clinical Support Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: TG Therapeutics, Inc.

Disqualifiers: Cancer, Hepatitis B, HIV, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current disease modifying therapy (DMT) before joining the trial, and there is a specific washout period (time without taking certain medications) required before receiving treatment.

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for individuals with progressive forms of Multiple Sclerosis, including Primary Progressive and Secondary Progressive MS. Participants must have stopped any disease modifying therapy before joining the study and meet specific criteria for medication washout.

Inclusion Criteria

My condition is Progressive Multiple Sclerosis.

I have stopped all disease modifying treatments as required.

Exclusion Criteria

Viral Screening: Evidence of chronic active or history of hepatitis B virus (HBV), Seropositive for human immunodeficiency virus (HIV) antibody

I have not had treatments like CAR T-cell therapy.

I have had cancer that was not in remission for at least 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of intravenous (IV) infusion of azer-cel at different dose levels

4 weeks

1 visit (in-person) on Day 0

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Azercabtagene zapreleucel (azer-cel)

Trial Overview The trial is testing Azercabtagene zapreleucel (azer-cel) to find out the safest and most effective dose for treating B-cell mediated autoimmune disorders, specifically focusing on its use in Multiple Sclerosis.

Participant Groups

Group I: Azer-cel Experimental Treatment 1 Intervention

Participants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.

Who Is Running the Clinical Trial?

TG Therapeutics, Inc.

Lead Sponsor

Trials

41

Recruited

6,900+