A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
Recruiting
Phase 1Interventional Study
B-cell Mediated Autoimmune Disorders
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
TG Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with specific autoimmune disorders who want to explore a new treatment called Azer-cel. Participants will undergo tests and may have a procedure to collect fluid from their spine.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have a specific autoimmune disorder diagnosed by a doctor.
I have not improved from my condition over the past year.
I am willing to have a lumbar puncture for testing.
I have a certain score on a disability assessment.
I have tested positive for specific antibodies related to my condition.
You may not be able to join if
I have had any type of cancer that is not in remission for at least 2 years.
I have recent blood clots or bleeding disorders.
I have a history of certain viral infections like hepatitis B or HIV.
I have had a stem cell or organ transplant.
I have previously received gene therapy for my condition.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
PMS and RMS inclusion criteria:
1. Age 18 years to ≤60 years (inclusive) at screening.
2. Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
3. Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (n…
Inclusion Criteria:
PMS and RMS inclusion criteria:
1. Age 18 years to ≤60 years (inclusive) at screening.
2. Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
3. Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).
4. Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit.
5. Willingness and ability to undergo lumbar puncture (LP) for cerebrospinal fluid (CSF) collection at protocol-specified timepoints, with no contraindications to the procedure in the opinion of the Investigator.
NMOSD inclusion criteria:
1. Between age 18 and ≤ 75 years, inclusive at the time of signing the informed consent.
2. EDSS score between 2.0 and 7.0 at screening, inclusive (for higher EDSS, the Investigator must assess that the participant is reasonably able to participate in the study).
3. Diagnosis of anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive at screening (verified by the allocated central laboratory) and Neuromyelitis Optica Spectrum Disorder (NMOSD).
4. Must meet the appropriate NMOSD treatment washout criteria prior to receiving lymphodepletion.
MG Inclusion criteria:
1. Age ≥18 and ≤75 years of age at the time of signing the informed consent.
2. Diagnosed with gMG at least 1 year prior to the date of signing the informed consent.
3. Confirmation of MG Diagnosis:
1. Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND
2. One of the following (either historical or during screening):
* Abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation.
* Positive anticholinesterase test (e.g., edrophonium chloride test).
* Demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
4. MG activities of daily living (MG-ADL) score ≥6 at screening.
CIDP Inclusion criteria
1. Age ≥18 and ≤75 years of age at the time of signing the informed consent.
2. Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Separately, Autoimmune Nodopathy (AN) participants with anti-CNTN1 or anti-NF155/anti-NF186, as confirmed by serological testing, may be included.
3. CIDP Disease Activity Status (CDAS): CDAS score ≥3 at screening.
4. INCAT Disability Score: INCAT disability score ≥4 to ≤9 score at screening.
General Exclusion Criteria:
1. History of malignancy that has not been in remission for at least 2 years.
2. Active venous thromboembolism (e.g., deep vein thrombosis or pulmonary embolism), clinically significant coagulopathy (e.g., disseminated intravascular coagulation), or current therapeutic anticoagulation (e.g., warfarin).
3. Viral and Tuberculosis (TB) Screening
1. Evidence of chronic active or history of hepatitis B virus (HBV).
2. Seropositive for human immunodeficiency virus (HIV) antibody.
4. History of bone marrow/hematopoietic stem cell or solid organ transplantation.
5. Prior treatment with any gene therapy product directed at any target (e.g. CAR T-cell therapy), with the exception of azer-cel.
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.