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

Start date

May 6, 2025

Status verified

May 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)

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