CARsgen Announces CT041 Granted RMAT Designation to treat gastroesophageal junction adenocarcinoma by the FDA

Jul 18 2025

/

CARsgen Announces CT041 Granted RMAT Designation by the FDA

CARsgen Therapeutics Holdings Limited, a company primarily focused on developing novel CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today that CT041 had been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the US Food and Drug Administration (FDA) for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) with Claudin18.2-positive tumor.

Source: CARsgen Therapeutics Holdings Limited

Gastroesophageal junction adenocarcinoma is a type of carcinoma in which the tumor’s epicenter is located within the GEJ region. It is a significant clinical problem that increases disease burden and poor prognosis. Most patients present with advanced disease, and less than half receive curative treatment. In most studies, tumor infiltration of the proximal or distal resection margin has been linked to a lower chance of survival. The Siewert classification is used for adenocarcinomas located within 5 cm of the GEJ. The three types of GEJ adenocarcinomas are as follows. Type I adenocarcinoma of the distal esophagus is found 1–5 cm above the GEJ. Type II is a true cardia carcinoma located between 1 cm above and 2 cm below the GEJ. Subcardial carcinoma of type III is found 2–5 cm below the GEJ. Adenocarcinoma of the gastroesophageal junction (GEJ) is a significant clinical problem with an increasing incidence and a poor prognosis. Most patients present with advanced disease, and less than half receive curative treatment.

  • The incidence of Gastroesophageal junction adenocarcinoma ranges from 2.8 to 3.9 per 100,000 population in the USA.

However, the current Gastroesophageal junction adenocarcinoma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (EP-104IAR, DS-8201a, Bemarituzumab, Avelumab, QL1604, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Gastroesophageal junction adenocarcinoma treatment. The key companies in the advanced development stage are Akeso, Daiichi Sankyo, Inc., Amgen, Gilead Sciences, Qilu Pharmaceutical Co., Ltd., etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market insight report on Gastroesophageal junction adenocarcinoma to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making

  • Delivery Office:
    B-1030, C Wing Vrindavan tech village, Outer ring road
    Bangalore- 560037
    India+91(124)404-1731
    clientsupport@thelansis.com
  • Sales office:
    183 Asylum Street Hartford,
    CT-06103, USA
    Contact no. +1 (302) 380-3552
    m.berg@thelansis.com

Leave a Reply

Your email address will not be published. Required fields are marked *