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CT041-CG4006 (Cohort 3) — Satri-cel (CT041), Claudin18.2 CAR T, advanced gastric/GEJ adenocarcinoma, sequential therapy after 1L

Abstract: 2557 · Session: Poster — May 30, 2026, 13:30–16:30 CDT · Presenter: CARsgen Therapeutics (presenter not individually named in release) · Embargo: May 30, 2026

At a glance

  • Sponsor: CARsgen Therapeutics Holdings Limited (investigator-initiated trial)
  • PI / presenter: Not individually named in company release
  • NCT ID: NCT03874897
  • Phase: Phase 1 (open-label, multi-cohort)
  • Design: Subgroup analysis of Cohort 3 — satri-cel given sequentially after first-line therapy in Claudin18.2+ gastric/GEJ adenocarcinoma; single infusion at 2.50×10⁸ cells
  • N: 5 (Claudin18.2+ gastric/GEJ; poor-prognosis — diffuse/signet-ring, peritoneal mets)
  • Primary endpoint(s): Safety and efficacy (ORR, DOR, PFS)
  • Comparator: None (single-arm)
  • Indication: Advanced gastric / gastro-esophageal junction adenocarcinoma
  • Line: Sequential / maintenance after first-line therapy

Headline result

In this long-term (>4.5 year) follow-up of Cohort 3 from CT041-CG4006 (NCT03874897), 5 Claudin18.2+ gastric/GEJ patients received satri-cel sequentially after first-line therapy. All 4 patients with measurable target lesions achieved a confirmed objective response (ORR 100%, 4/4). Median duration of response was not reached and median PFS measured from initiation of first-line therapy was 20.9 months, at the October 18, 2025 data cutoff (median follow-up 54.6 months from initial 1L therapy). Two patients achieving clinical benefit underwent surgical resection after satri-cel and both remained alive at 58.1 and 51.1 months. No grade ≥3 CRS, ICANS, treatment-related deaths, grade ≥3 infections, or febrile neutropenia were reported. All figures per CARsgen press release, May 30, 2026; small N=5 subgroup.

Mechanism / class

Satricabtagene autoleucel (satri-cel, CT041) is an autologous CAR T-cell therapy targeting Claudin18.2, a tight-junction protein highly expressed in gastric/GEJ and pancreatic adenocarcinoma. In the randomized phase 2 CT041-ST-01 trial (later-line G/GEJ), satri-cel improved PFS vs physician's choice (published in The Lancet, 2025). In China, the NMPA accepted the satri-cel NDA (June 2025) with Breakthrough Therapy Designation (March 2025) and Priority Review (May 2025) for Claudin18.2+ advanced G/GEJA after ≥2 prior lines.

Practice-changing?

No / pending. This is a hypothesis-generating N=5 subgroup from an early-phase IIT, not a controlled comparison. The durable responses and 20.9-month PFS-from-1L in a poor-prognosis population (diffuse/signet-ring, peritoneal mets) support moving satri-cel earlier into a sequential/maintenance setting after 1L, but practice change awaits a randomized first-line-adjacent study. Regulatory momentum for satri-cel rests on the later-line CT041-ST-01 data, not this cohort.

Sources

  • ASCO Meeting Library (Abstract 2557): https://meetings.asco.org/abstracts-presentations/
  • CARsgen press release (PR Newswire), May 30, 2026: http://www.prnewswire.com/news-releases/long-term-follow-up-results-of-carsgens-satri-cel-as-sequential-therapy-after-first-line-treatment-for-gastric-cancer-presented-at-the-2026-asco-annual-meeting-302785542.html
  • CARsgen press release (BioSpace): https://www.biospace.com/press-releases/long-term-follow-up-results-of-carsgens-satri-cel-as-sequential-therapy-after-first-line-treatment-for-gastric-cancer-presented-at-the-2026-asco-annual-meeting
  • CT041-ST-01 phase 2 (The Lancet, 2025): https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00860-8/abstract