A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

TG Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: B-cell Mediated Autoimmune Disorders

Treatments: Drug: Azercabtagene zapreleucel (azer-cel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06680037

TG-Azercel-101

Details and patient eligibility

About

The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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: Please note, other protocol specified Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Azer-cel

Experimental group

Description:

Participants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.

Treatment:

Drug: Azercabtagene zapreleucel (azer-cel)