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Emerging treatmentsPhase 1 study evidenceCurrent human-study status unknown

Azer-cel: donor-derived CAR T cells in progressive MS

Published by MyelinWatch:

Organisation
TG Therapeutics · United States
Study sponsor
TG Therapeutics
Researcher
Daniel Ontaneda and colleagues

Azer-cel (TG-Azercel-101) · TG-Azercel-101 studies azer-cel (azercabtagene zapreleucel), donor-derived CAR T cells designed to target CD19-positive B cells in progressive multiple sclerosis (MS). Participants receive one infusion after bendamustine lymphodepletion. This Phase 1 study chiefly assesses safety and early biological and clinical measures.

What is being studied

TG-Azercel-101 studies azer-cel (azercabtagene zapreleucel), donor-derived CAR T cells designed to target CD19-positive B cells in progressive multiple sclerosis (MS). Participants receive one infusion after bendamustine lymphodepletion. This Phase 1 study chiefly assesses safety and early biological and clinical measures.

Research stage

Phase 1 study evidence; current human-study status is unknown

The programme is listed as active; current human-study status is unknown.

What we know so far

Initial conference data cover 26 treated people, with median follow-up of 4.9 months at the 3 September 2026 cutoff. EDSS was stable or improved in 16/18 evaluable people at Day 90 and 7/8 at Day 180. Grade 3 or higher treatment-emergent adverse events occurred in 11/26 and serious adverse events in 4/26; no defined high-grade CAR-T toxicities were reported. These are descriptive results without a comparator.

What this means for patients today

Azer-cel remains investigational for MS. Disability and MRI observations cannot prove benefit, and the small group and short follow-up cannot establish broad safety. The sponsor reports ongoing dose escalation, but official recruitment status is unverified. Greek availability and reimbursement are unverified.

Next documented step

Dose escalation and longer follow-up, according to sponsor

Treatment or approach
Donor-derived CD19-directed CAR T cells for progressive MS
How it is intended to work
Donor-derived anti-CD19 CAR T-cell therapy after bendamustine lymphodepletion
Where the study is running
United States; Greek access unverified
Source: TG Therapeutics — sponsor conference presentation ↗Source: TG Therapeutics — initial Phase 1 results ↗ Source: OhioHealth — TG-Azercel-101 and NCT06680037 identity ↗
Published by MyelinWatch
Last substantive MyelinWatch update

Programme updates — newest research developments first

  1. Early human Phase 1 resultsResearch event/source date:

    Azer-cel: first Phase 1 results in 26 people with progressive MS

    At the 3 September 2026 data cutoff, 26 people had received azer-cel and median follow-up was 4.9 months. EDSS disability scores were stable or improved in 16/18 evaluable people at Day 90 and 7/8 at Day 180. Grade 3 or higher treatment-emergent adverse events occurred in 11/26, and serious adverse events in 4/26. No dose-limiting toxicity, Grade 3 or higher cytokine-release syndrome, Grade 2 or higher neurotoxicity, graft-versus-host disease or IEC-HS was reported.

    Source: TG Therapeutics — sponsor conference presentation ↗Source: TG Therapeutics — 23 October 2026 announcement ↗