Who is sponsoring NCT06680037?

NCT06680037 is sponsored by TG Therapeutics, Inc..

What drugs are being tested in NCT06680037?

Interventions in NCT06680037: Azercabtagene zapreleucel (azer-cel).

What condition does NCT06680037 study?

NCT06680037 studies B-cell Mediated Autoimmune Disorders.

Is NCT06680037 still recruiting?

NCT06680037 is currently recruiting now. Last updated 7 April 2026.

Last reviewed 2026-04-07 · How we verify

NCT06680037

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 7 April 2026

What this trial tests

Phase 1 trial testing Azercabtagene zapreleucel (azer-cel) in B-cell Mediated Autoimmune Disorders in 32 participants. Currently enrolling.

Timeline

6 May 2025

Primary endpoint
1 December 2026

1 January 2029

Quick facts

Lead sponsor	TG Therapeutics, Inc.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	6 May 2025
Primary completion	1 December 2026
Estimated completion	1 January 2029
Sites	9 locations across United States

Drugs / interventions tested

Azercabtagene zapreleucel (azer-cel) — full drug profile →

Conditions studied

B-cell Mediated Autoimmune Disorders — all drugs for B-cell Mediated Autoimmune Disorders →

Sponsor

TG Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with B-cell Mediated Autoimmune Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Roads and detours for CAR T cell therapy in autoimmune diseases.
Avouac J, Barzel A, Caiati D, Davis RS, et al · · 2026 · cited 1× · PMID 41588112 · DOI 10.1038/s41573-025-01349-4
CAR T-cells meet autoimmune neurological diseases: a new dawn for therapy.
Chinas NA, Alexopoulos H. · · 2025 · cited 1× · PMID 40755780 · DOI 10.3389/fimmu.2025.1604174
From insights to innovations: evaluating preclinical paradigms in demyelinating disease therapeutics.
Karbalaee M, Lin A, Peruzzotti-Jametti L, Pluchino S, et al · · 2026 · PMID 41998189 · DOI 10.1038/s41684-026-01725-6
CAR T-Cell Immunotherapy in Neuroautoimmune Diseases: Focus on the Central Nervous System
Demetriou F, Anagnostouli M. · · 2026

Verify or expand the search:

Other recruiting trials for B-cell Mediated Autoimmune Disorders

Currently open trials in the same condition.

NCT07148791 — Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease · Phase 2 · recruiting

Other TG Therapeutics, Inc. trials

Trials by the same sponsor.

NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis · Phase 2, PHASE3 · not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection · Phase 2 · not yet recruiting
NCT07211633 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ub · Phase 3 · recruiting
NCT06433752 — A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Mult · recruiting
NCT06433765 — A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple S · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06680037 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TG Therapeutics, Inc.
Last refreshed: 7 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06680037.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing