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Marco Donia: CAR-T Cells for Gastro-Oesophageal Cancer – First Randomized Trial of CAR-T in Solid Tumors

Marco Donia/LinkedIn

Jun 13, 2025, 14:09

Marco Donia: CAR-T Cells for Gastro-Oesophageal Cancer – First Randomized Trial of CAR-T in Solid Tumors

Marco Donia, Research Group Leader of the TIL group at CCIT (Center for Cancer Immune Therapy) and Professor at the University of Copenhagen , shared a post on LinkedIn:

“CAR-T cells for gastro-oesophageal cancer. First randomized trial of CAR-T in solid tumors (The Lancet, Qi et al., June 7th 2025)

CT041-ST-01 trial enrolled 156 patients in China with HER2-negative, CLDN18.2-positive advanced gastric or gastro-oesophageal junction cancer, all previously treated with ≥2 lines of therapy.

104 were randomized to CAR-T therapy (satri-cel, targeting claudin-18 isoform 2 [CLDN18.2], after lymphodepletion), 52 to physician’s choice. Crossover allowed at progression.

Key points:

Progression-free Survival: 3.25 vs 1.77 months (HR 0.37; 95% CI 0.24–0.56; one-sided log-rank p<0.0001)

Overall Survival (non-adjusted for crossover): 7.9 vs 5.5 months (HR 0.67; 95% CI 0.43–1.03; one-sided log-rank p=0.054)

ORR: 22% with satri-cel vs 4% with standard treatment

Toxicity:Satri-cel: Grade ≥3 AEs in 97%; CRS in 95% (7% grade ≥3)

Control group: Grade ≥3 AEs in 67%; no CRS reported

Logistics: 16 patients couldn’t proceed after apheresis due to rapid progression

Additional considerations:

CLDN18.2 positivity cutoff was lowered (≥40% vs ≥75% in zolbetuximab trials): broadens inclusion but complicates comparisons

Trial setting and therapies may limit generalisability beyond East Asia

Effective delivery still requires CAR-T centers equipped for complex logistics and toxicity management

Clinical implications:

This is the first randomized evidence for CAR-T therapy in solid tumors.Not ready for routine use yet, but a pivotal step forward.”

Title: Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician’s choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial

Authors: Changsong Qi, Chang Liu, Zhi Peng, Yanqiao Zhang, Jia Wei, Wensheng Qiu, Xiaotian Zhang, Hongming Pan, Zuoxing Niu, Meng Qiu, Yanru Qin, Weijia Fang, Feng Ye, Ning Li, Tianshu Liu, Anwen Liu, Xizhi Zhang, Changlu Hu, Jun Zhang, Jiuwei Cui, Xiaoyan Lin, Shubin Wang, Jian Zhang, Tongyu Lin, Xiujuan Qu, Xianglin Yuan, Jifang Gong, Jian Li, Wanwan Gao, Lun Gai, Yumeng Wang, Daijing Yuan, Zonghai Li, Lin Shen

You can read the Full Article on The Lancet Journal

Marco Donia: CAR-T Cells for Gastro-Oesophageal Cancer - First Randomized Trial of CAR-T in Solid Tumors

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Marco Donia: CAR-T Cells for Gastro-Oesophageal Cancer – First Randomized Trial of CAR-T in Solid Tumors

“CAR-T cells for gastro-oesophageal cancer. First randomized trial of CAR-T in solid tumors (The Lancet, Qi et al., June 7th 2025)

CT041-ST-01 trial enrolled 156 patients in China with HER2-negative, CLDN18.2-positive advanced gastric or gastro-oesophageal junction cancer, all previously treated with ≥2 lines of therapy.

104 were randomized to CAR-T therapy (satri-cel, targeting claudin-18 isoform 2 [CLDN18.2], after lymphodepletion), 52 to physician’s choice. Crossover allowed at progression.

Key points:

Progression-free Survival: 3.25 vs 1.77 months (HR 0.37; 95% CI 0.24–0.56; one-sided log-rank p<0.0001)

Overall Survival (non-adjusted for crossover): 7.9 vs 5.5 months (HR 0.67; 95% CI 0.43–1.03; one-sided log-rank p=0.054)

ORR: 22% with satri-cel vs 4% with standard treatment

Toxicity:Satri-cel: Grade ≥3 AEs in 97%; CRS in 95% (7% grade ≥3)

Control group: Grade ≥3 AEs in 67%; no CRS reported

Logistics: 16 patients couldn’t proceed after apheresis due to rapid progression

Additional considerations:

CLDN18.2 positivity cutoff was lowered (≥40% vs ≥75% in zolbetuximab trials): broadens inclusion but complicates comparisons

Trial setting and therapies may limit generalisability beyond East Asia

Effective delivery still requires CAR-T centers equipped for complex logistics and toxicity management

Clinical implications:

This is the first randomized evidence for CAR-T therapy in solid tumors.Not ready for routine use yet, but a pivotal step forward.”