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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Azercabtagene zapreleucel (azer-cel) — DRUG
  IV infusion

Study Details

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

Key Dates

First listed

Nov 8, 2024

Start date

May 6, 2025

Status verified

Jun 2026

Primary completion

Dec 1, 2027

Completion

Jan 1, 2030

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Day 0 to Day 28 ]

Central Contacts

• TG Therapeutics Clinical Support Team
  1-877-575-8489
  [email protected]

Locations (8)

Find similar trials in La Jolla, CA