RECRUITING

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

Conditions

B-cell Mediated Autoimmune Disorders Progressive forms of multiple sclerosis (PMS)Primary Progressive MS (PPMS)Secondary Progressive MS (SPMS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders

Quick Facts

Study Start:2025-01-17

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06680037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Study Contact

TG Therapeutics Clinical Support Team

CONTACT

1-877-555-8489

clinicalsupport@tgtxinc.com

Study Locations (Sites)

TG Therapeutics Investigational Trial Site

Lexington, Kentucky, 40506

United States

Collaborators and Investigators

Sponsor: TG Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2025-01-17

Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

Progressive forms of multiple sclerosis (PMS)
Primary Progressive MS (PPMS)
Secondary Progressive MS (SPMS)

Additional Relevant MeSH Terms

B-cell Mediated Autoimmune Disorders