Direct answer
In the pivotal CT041-ST-01 trial (The Lancet, 2025), satri-cel more than halved the rate of progression or death against the physician's choice of drug — median progression-free survival 3.25 versus 1.77 months, hazard ratio 0.37 (95% CI 0.24–0.56), in 156 heavily pre-treated patients.1
Overall survival moved the same way (7.92 versus 5.49 months, hazard ratio 0.69) but reached significance only at the trial's one-sided threshold; the response rate was 22% against 4%. The cost was a near-universal grade 1–2 cytokine release syndrome and the haematological toxicity of lymphodepletion, with no neurotoxicity.13
2019 → 2022
Phase 1: the signal
The investigator-initiated first-in-human study (NCT03874897) at Peking University Cancer Hospital treated 37 patients with previously treated, Claudin18.2-positive digestive-system cancers at three dose levels. Its interim results in Nature Medicine are the reason a randomised trial was ever run.2
| Measure | All patients (n=37) | Gastric cancer subgroup | Note |
|---|---|---|---|
| Doses tested | 2.5 / 3.75 / 5.0 × 10⁸ cells | — | No dose-limiting toxicity at any level |
| Objective response rate | 48.6% | 57.1% | Heavily pre-treated population |
| Disease control rate | 73.0% | 75.0% | |
| Six-month duration of response | 44.8% | — | |
| Six-month overall survival | — | 81.2% | |
| Cytokine release syndrome | 94.6%, all grade 1–2 | — | No grade ≥3 CRS; no neurotoxicity; no treatment-related deaths |
| Haematological toxicity grade ≥3 | 100% | — | The lymphodepletion signature |
Primary sourceQi C et al., Nature Medicine 2022;28:1189–1198, PMID 35534566.2
2022 → 2025
CT041-ST-01: the randomised trial
Open-label, multicentre, randomised 2:1 across China. Eligible patients had Claudin18.2-positive (IHC ≥2+ in ≥40% of cells) advanced gastric or gastro-oesophageal junction cancer refractory to at least two prior lines. Satri-cel was infused at 250 × 10⁶ cells, up to three times, after lymphodepletion; the control arm received one of nivolumab, paclitaxel, docetaxel, irinotecan or apatinib at the physician's discretion, with crossover to satri-cel permitted on progression. The primary endpoint was independent-review progression-free survival in the intention-to-treat population.1
Between 22 March 2022 and 29 July 2024, 266 patients were screened and 156 randomised: 104 to satri-cel and 52 to control. Of those, 88 (85%) and 48 (92%) received study treatment — the gap on the satri-cel side is the wait for manufactured cells, and it is part of what the intention-to-treat analysis measures.1
Efficacy, population by population
| Population | Endpoint | Satri-cel | Physician's choice | Hazard ratio (95% CI) | Source |
|---|---|---|---|---|---|
| Intention-to-treat (104 vs 52) | Median PFS | 3.25 mo (2.86–4.53) | 1.77 mo (1.61–2.04) | 0.37 (0.24–0.56), p<0.0001 | 1 |
| Median OS | 7.92 mo (5.78–10.02) | 5.49 mo (3.94–6.93) | 0.69 (0.46–1.05), p=0.0416 | 3 | |
| Objective response | 22% (15–31) | 4% (0–13) | — | 3 | |
| Disease control · median DoR | 63% (52–72) · 5.52 mo | 25% (14–39) | — | 3 | |
| Modified ITT (treated: 88 vs 48) | Median PFS | 4.37 mo | 1.84 mo | 0.304 (0.195–0.474) | 4 |
| Median OS | 8.61 mo | 5.49 mo | 0.601 (0.385–0.939) | 4 | |
| Exploratory (vs control never crossed over) | Median OS | 9.17 mo | 3.98 mo | 0.288 (0.169–0.492) | 4 |
| Crossover (20 control patients) | Median OS after satri-cel | 9.20 mo | — | — | 4 |
LiteratureMedian follow-up for PFS was 9.07 months in the satri-cel arm and 3.45 months in the control arm — a difference some Chinese secondary reporting has misread as the PFS result itself. The PFS medians are 3.25 and 1.77 months; the follow-up figures describe how long patients were watched.1
Safety, by grade
| Event (safety set) | Satri-cel (n=88) | Physician's choice (n=48) | Source |
|---|---|---|---|
| Any grade ≥3 treatment-emergent AE | 87 (99%) | 30 (63%) | 1 |
| Decreased lymphocytes (grade ≥3, treatment-related) | 86 (98%) | — | 1 |
| Decreased white cells (grade ≥3) | 68 (77%) | — | 1 |
| Decreased neutrophils (grade ≥3) | 58 (66%) | — | 1 |
| Cytokine release syndrome, any grade | 84 (95%) · 90.9% grade 1–2 · 4.5% grade 3 | — | 14 |
| Neurotoxicity (ICANS) | 0 | 0 | 4 |
| Serious treatment-related AE | 35.2% | 25% | 4 |
| Treatment-related death | 1 | 1 | 4 |
MechanismThe lymphodepletion regimen: fludarabine 30 mg/m² and cyclophosphamide 250 mg/m² on days 1–3, with nab-paclitaxel 100 mg on day 2 — the chemotherapy that clears space for the cells and, the investigators argue, loosens the fibrotic barrier of a gastric tumour.4 The on-target, off-tumour question for the gastric mucosa is set out on the target page.
What the evidence does not establish
- A survival benefit at conventional significance. The ITT overall-survival hazard ratio's confidence interval crosses 1 (0.46–1.05); the p value is one-sided. The mITT and exploratory analyses are stronger but are not the primary analysis.34
- Durability. Median duration of response was 5.52 months. A minority of responders — the peritoneal-metastasis series below, the sequential-therapy patients — have gone years; most have not.36
- Generalisability. One country, one manufacturing site, an open-label design, and 15% of the satri-cel arm never dosed. The overseas phase 1b/2 (NCT04404595) is active but not yet reported.19
- The n=5. The 2026 ASCO sequential-therapy data are a five-patient investigator-initiated series; a Chinese clinician quoted in the business press said exactly that — whether the effect holds in larger groups needs more trials.711
Beyond the medians
The long tail, and the earlier line
LiteratureThree patients with peritoneal metastases — the site that makes gastric cancer so hard to treat — achieved durable peritoneal control after Claudin18.2 CAR-T, two of them with overall survival of 44 and 35 months.6 In an investigator-initiated study of satri-cel given sequentially after first-line chemotherapy, presented at ASCO 2026, five patients had a confirmed response rate of 100% among the four with measurable disease, a median PFS from first-line therapy of 20.9 months, no grade ≥3 cytokine release syndrome, and two who went on to surgical resection were alive at 58.1 and 51.1 months.7 That is the company's statement of an n=5 series; it is the hypothesis behind the sequential-therapy study now recruiting (NCT07179484), not a result.9
Who responds
Biomarkers of response and resistance
Because the phase 1 programme treated nearly a hundred patients over several years, the Beijing group has been able to ask what separated responders from the rest. The answers so far are about the host and the product as much as the tumour.
| Factor | Finding | Numbers | Source |
|---|---|---|---|
| Neutrophil-to-lymphocyte ratio | High NLR predicts worse outcome; neutrophils contribute to resistance | ORR 34.2% vs 55.9% · mPFS 3.6 vs 8.0 mo · mOS 5.6 vs 13.8 mo | 5 |
| Antibiotic exposure | Concomitant antibiotics shorten PFS and OS | mPFS 2.6 vs 5.8 mo · mOS 3.9 vs 9.5 mo | 8 |
| Product composition | A high proportion of naïve-like T cells favours benefit | Single-cell sequencing of treated patients | 10 |
| Ascites biology | MYC-high epithelial cells in ascites are adverse | Same study | 10 |
The registry
Every registered satri-cel study, and the field around it
Enumerated from ClinicalTrials.gov on 15 September 2026. A registry search for CT041, satri-cel or satricabtagene returns nine records, eight of them the therapy's own (the ninth is an unrelated insulin study that matches on a token).9
| Registry ID | Study | Phase | Sponsor | Status | Start |
|---|---|---|---|---|---|
| NCT03159819 | CAR-CLD18 T cells, advanced gastric and pancreatic adenocarcinoma — the first Claudin18.2 CAR-T study | — | Changhai Hospital | Unknown | 2017 |
| NCT03874897 | CT041 first-in-human (CT041-CG4006), solid tumours | 1 | Peking University | Completed (n=134) | 2019 |
| NCT04581473 | CT041-ST-01, the pivotal randomised trial | 1/2 | CARsgen | Active, not recruiting (n=192) | 2020 |
| NCT04404595 | CT041 in gastric, pancreatic and other digestive cancers — United States and Canada | 1/2 | CARsgen | Active, not recruiting (n=110) | 2020 |
| NCT05911217 | CT041 after adjuvant chemotherapy, pancreatic cancer (CT041-ST-05) | 1 | CARsgen | Recruiting (n=20) | 2023 |
| NCT06857786 | Post-operative consolidation, gastric/GEJ (CT041-CG4010) | 1 | Peking University | Not yet recruiting (n=48) | 2025 |
| NCT07179484 | Sequential treatment after first-line therapy, advanced GEJ (CT041-CG4011) | — | Beijing GoBroad Hospital | Recruiting (n=20) | 2025 |
| NCT05472857 | A different CLDN18.2 CAR-T (Immunofoco) matched by the search token | 1 | Suzhou Immunofoco | Unknown | 2022 |
Primary sourceThe wider count is the review's: 143 Claudin18.2 gastric-cancer trials, most still early-phase.12 On PubMed, a search for CT041, satri-cel or satricabtagene returns 16 records and a search for Claudin18.2 CAR returns 71, both on 15 September 2026.
Panacea lens
Reading a trial the way an engineer reads a spec
Panacea research noteFifteen percent of the arm never got the drug
The most quietly important number in CT041-ST-01 is not a hazard ratio. It is that 16 of 104 patients randomised to satri-cel were never infused, because an autologous product is manufactured for one person and a fourth-line gastric cancer does not wait. Every step between apheresis and infusion — the days of transduction and expansion, the release testing, the cold chain, the lymphodepletion window — is time the tumour keeps. Shortening that chain is as real a therapeutic gain as a better binder.
Panacea technologyPanacea Bio Chem researches this sphere from the side of the molecules that surround the cell product: the cytokines and peptides that expand, arm and sustain the T cells, and the preservation science that keeps such molecules active until they are used. That is what the Lyoprester™ dual-chamber cartridge and the TgShift™ and Cryolapse™ drying governors are for; Panacea's position is that the best peptide source worldwide is the one that holds the chain from design to a sealed, reconstitution-ready cartridge, and it built that chain itself. Exact procedures and parameters are proprietary.
Panacea peptides — Peptourbillon™ dual-chamber presentations ↗
Continue
The rest of the resource
Current literature
Trending in the field
Recent literature touching Claudin18.2 and solid-tumour CAR-T — retrieved from PubMed, 15 September 2026.
- First CAR T-Cell Therapy Approved for Solid Tumors — Cancer Discov, 2026 Sep 1
- Long-term control of peritoneal metastases following claudin 18.2-targeted CAR T-Cell therapy in advanced gastric cancer — J Hematol Oncol, 2026 Jul 1
- Impact of concomitant medications on efficacy of CLDN18.2-specific CAR-T cell therapy in advanced gastric cancer — Br J Cancer, 2026 Feb
- A two-step scoring model incorporating visceral-to-subcutaneous fat ratio and systemic immunoinflammatory index for predicting cytokine release syndrome severity — Cancer Immunol Immunother, 2026 Mar 9
Literature
References
Retrieved at the identifier given on 15 September 2026. Company statements are labelled as such.
Questions
Frequently asked
What is the primary result of CT041-ST-01?
Median progression-free survival of 3.25 months with satri-cel versus 1.77 months with the physician's choice of drug, intention-to-treat, hazard ratio 0.37 (95% CI 0.24–0.56), p<0.0001.1
Did satri-cel improve overall survival?
Median OS was 7.92 versus 5.49 months (ITT; HR 0.69, 95% CI 0.46–1.05), significant only at the one-sided threshold (p=0.0416). Among patients who actually received satri-cel, 8.61 versus 5.49 months (HR 0.60); against control patients who never crossed over, 9.17 versus 3.98 months in an exploratory analysis.34
