B-cell Mediated Autoimmune Disorders study: Azercabtagene zapreleucel
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 cell therapy being studied 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 study aims to find the safest and most effective dose for future trials.
- Who it's for
- Adults who have a B‑cell mediated autoimmune disorder.
- What's involved
- Participants will receive a single infusion of azer-cel and will have follow‑up visits to monitor safety and response.
- Time commitment
- The study lasts a few weeks to months, with several clinic visits for monitoring.
- 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.
You likely can't join if
- History of malignancy that has not been in remission for at least 2 years.
- Active venous thromboembolism (e.g., deep vein thrombosis or pulmonary embolism), clinically significant coagulopathy (e.g., disseminated...
- Viral and Tuberculosis (TB) 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.
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.
- 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
- Between age 18 and ≤ 75 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 ≤75 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.
- Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND
- 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 ≤75 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.
- 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...
- Viral and Tuberculosis (TB) 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 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.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.