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CAR T-cell Therapy

Azer-cel for Autoimmune Disease

Lexington, KY
Phase 1
Recruiting
Research Sponsored by TG Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS
Be between 18 and 65 years old
Must not have
Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy)
History of malignancy that has not been in remission for at least 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 0 to day 28
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to find the appropriate dose of Azercabtagene zapreleucel (azer-cel) for phase 2 of the study."

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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, side effects of azer-cel may include typical reactions to cellular therapies such as fever, fatigue, headache, or more serious complications like immune system overactivity or low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is Progressive Multiple Sclerosis.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had treatments like CAR T-cell therapy.
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I have had cancer that was not in remission for at least 2 years.
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I have had a bone marrow, stem cell, or organ transplant.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 0 to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 to day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Dose-Limiting Toxicities (DLTs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Azer-celExperimental Treatment1 Intervention
Participants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.

Find a Location

Closest Location:TG Therapeutics Investigational Trial Site· Lexington, KY· 158 miles
Image of TG Therapeutics Investigational Trial Site in Lexington, United States.Image of TG Therapeutics Investigational Trial Site in Lexington, United States.Image of TG Therapeutics Investigational Trial Site in Lexington, United States.

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor
40 Previous Clinical Trials
6,825 Total Patients Enrolled
~21 spots leftby Dec 2026
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