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Tests treatment safety and results for B-cell Mediated Autoimmune Disorders
Official title A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
ClinicalTrials.gov ID: NCT06680037
What this study is testing
What is Azercabtagene zapreleucel (azer-cel)?
Azercabtagene zapreleucel (azer-cel) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell mediated autoimmune disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PMS and RMS
- Age 18 years to ≤60 years (inclusive) at screening.
- Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
- Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).
- Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit. NMOSD
You likely can't join if
- 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). Note: Other...
See the full eligibility criteria
- PMS and RMS
- Age 18 years to ≤60 years (inclusive) at screening.
- Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.
- Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).
- Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit. NMOSD
- Between age 18 and 65 years, inclusive at the time of signing the informed consent.
- 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).
- Diagnosis of anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive at screening (verified by the allocated central laboratory) and Neuromyelitis Optica Spectrum Disorder (NMOSD).
- Must meet the appropriate NMOSD treatment washout criteria prior to receiving lymphodepletion. MG
- Age ≥18 and ≤70 years of age at the time of signing the informed consent.
- Diagnosed with gMG at least 1 year prior to the date of signing the informed consent.
- Confirmation of MG Diagnosis:
- Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND
- 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.
- MG activities of daily living (MG-ADL) score ≥6 at screening. CIDP 1. Age ≥18 and ≤70 years of age at the time of signing the informed consent.
- Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome).
- CIDP Disease Activity Status (CDAS): CDAS score ≥3 at screening.
- INCAT Disability Score: INCAT disability score ≥4 to ≤9 score at screening. General
- 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). Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Ann Arbor, Michigan, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Rochester, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Ann Arbor, Michigan, United States; Omaha, Nebraska, United States; New York, New York, United States; Rochester, New York, United States; Cleveland, Ohio, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.