Calibrated CD19‑1XX CAR T Achieves 75% CR with Only 4% Grade ≥3 CRS in r/r LBCL
- Trial ID
- NCT04464200 on ClinicalTrials.gov
- Cancer type
- Large B-Cell Lymphoma
- Published in
- New in Oncology - Aug 1, 2025
19(T2)28z‑1XX, a CD19 CAR T cell engineered for “just‑right” 1XX signaling, was evaluated in the first‑in‑human phase I dose‑escalation/expansion study NCT04464200. Twenty‑eight adults with relapsed/refractory large B‑cell lymphoma received 25‑200 × 10⁶ cells; the 25 × 10⁶‑cell dose was selected for expansion (n = 16). Overall ORR was 82% with 71% CR; at the low dose ORR/CR were 88%/75%. After 24 months’ median follow‑up, 1‑yr event‑free survival reached 61%, and 14 patients remain in continuous CR beyond 12 months. Severe toxicities were rare (grade ≥3 CRS 4%, ICANS 7%). By comparison, axi‑cel yields 83% ORR/58% CR but grade ≥3 CRS 11% and ICANS 29%, while liso‑cel shows 73% ORR/53% CR with grade ≥3 CRS 1% and ICANS 14%—yet both use 1—2 × 10⁸ cells. Durable CAR persistence (>1 — 2 yrs) and a memory‑rich CD8 profile were documented.
Take home
Matching or beating approved CD19 CAR response rates at one‑quarter the cell dose and with markedly lower neuro/CRS rates, the 1XX platform looks poised to broaden CAR T access—but its single‑center, 28‑patient experience needs multi‑site confirmation before displacing axi‑cel or liso‑cel.
Source: Read the original publication
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