TG Therapeutics reports early Phase 1 safety and disability data for azer‑cel in progressive multiple sclerosis
TG Therapeutics presented initial results from its open‑label Phase 1 study of azer‑cel, an allogeneic CD19‑directed CAR‑T therapy, in 26 patients with progressive multiple sclerosis. No high‑grade CAR‑T toxicities were observed and B‑cell depletion was achieved in the majority of participants. At Day 90, 89% of the evaluable patients showed stable or improved disability scores, with five patients experiencing meaningful EDSS improvements. The company will continue dose escalation and longer‑term follow‑up.
Why it matters
The company says the safety profile and early signals of clinical activity could support further development of an off‑the‑shelf CAR‑T option for a disease with high unmet need. Investors should watch for subsequent trial cohorts and longer follow‑up data that will determine whether the therapy can advance to later‑stage studies.
Key facts
- 1The study enrolled 26 participants with progressive MS across six dose levels ranging from 30 million to 500 million CAR‑T cells. stocktitan.net
- 2Median baseline EDSS was 6.0 and median follow‑up was 4.9 months as of the September 3 2026 data cutoff. stocktitan.net
- 3No dose‑limiting toxicities or high‑grade CAR‑T‑associated events (≥Grade 3 CRS, ≥Grade 2 ICANS, graft‑versus‑host disease, ≥Grade 3 infections) were reported. stocktitan.net
- 4At Day 90, 89% of evaluable participants (16 of 18) had stable or improved EDSS scores. investing.com
- 5Five of the 18 evaluable patients showed EDSS improvements, including three with gains of two or more points. stocktitan.net
- 6Peripheral blood B‑cell counts fell below 10 cells/µL in 96% of participants (25 of 26). investing.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.