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

Phase 1RecruitingNCT06680037

TG Therapeutics, Inc.32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

B-cell Mediated Autoimmune Disorders

Interventions

Azercabtagene zapreleucel (azer-cel)DRUG

IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

TG Therapeutics Investigational Trial Site

La Jolla, California, United States

RECRUITING

TG Therapeutics Investigational Trial Site

Lexington, Kentucky, United States

NOT_YET_RECRUITING

TG Therapeutics Investigational Trial Site

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Number of Participants with Dose-Limiting Toxicities (DLTs)

DLT will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame: From Day 0 to Day 28

Secondary Outcomes

Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)

Time frame: Up to Day 720

Change From Baseline in CAR T-cell Toxicities

Time frame: Baseline, up to Day 720

Pharmacokinetics (PK) Plasma Concentrations of Azer-cel

Time frame: Up to Day 720

Pharmacodynamics (PD) Plasma Concentrations of Azer-cel

Time frame: Up to Day 720

Time to Confirmed Disability Progression (CDP)

Time frame: Up to Day 720

Time to Confirmed Disability Improvement (CDI)

Time frame: Up to Day 720

Change From Baseline in Brain MRI Gadolinium Enhancing T1, New or Enlarging Hyperintense T2

Time frame: Baseline, up to Day 720

Change From Baseline in Whole Brain Atrophy

Time frame: Baseline, up to Day 720

Change From Baseline in Modified Rankin Scale (mRS)

Time frame: Baseline, up to Day 720

Central Contacts

TG Therapeutics Clinical Support Team

CONTACT

1-877-575-8489 clinicalsupport@tgtxinc.com

Data from ClinicalTrials.gov

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