A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
NCT ID: NCT06680037
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
32 participants
INTERVENTIONAL
2025-05-06
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Azer-cel
Participants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.
Azercabtagene zapreleucel (azer-cel)
IV infusion
Interventions
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Azercabtagene zapreleucel (azer-cel)
IV infusion
Eligibility Criteria
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Inclusion Criteria
2. Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.
Exclusion Criteria
2. Viral Screening
1. Evidence of chronic active or history of hepatitis B virus (HBV).
2. Seropositive for human immunodeficiency virus (HIV) antibody.
3. History of bone marrow/hematopoietic stem cell or solid organ transplantation.
4. Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).
18 Years
60 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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TG Therapeutics Investigational Trial Site
La Jolla, California, United States
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, United States
TG Therapeutics Investigational Trial Site
Ann Arbor, Michigan, United States
TG Therapeutics Investigational Trial Site
Omaha, Nebraska, United States
TG Therapeutics Investigational Trial Site
New York, New York, United States
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, United States
TG Therapeutics Investigational Trial Site
Columbus, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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TG-Azercel-101
Identifier Type: -
Identifier Source: org_study_id