RECRUITINGPhase 1INTERVENTIONAL
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders
About This Trial
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Who May Be Eligible (Plain English)
Who May Qualify:
1. Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
2. Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.
Who Should NOT Join This Trial:
1. History of malignancy that has not been in remission for at least 2 years.
2. Viral Screening
1. Evidence of chronic active or history of hepatitis B virus (HBV).
2. Seropositive for human weakened immune system 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).
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
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:
1. History of malignancy that has not been in remission for at least 2 years.
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).
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Treatments Being Tested
DRUG
Azercabtagene zapreleucel (azer-cel)
IV infusion
Locations (8)
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
Rochester, New York, United States
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, United States
TG Therapeutics Investigational Trial Site
Columbus, Ohio, United States