View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
March 24, 2022

CARsgen enrols first subject in Phase II gastric cancer trial of T-cell therapy

The CDE of the National Medical Products Administration of China granted approval to begin the trial in GC/GEJ patients.

CARsgen Therapeutics has enrolled the first subject in the confirmatory Phase II clinical trial of its autologous CAR T-cell therapy candidate, CT041, to treat CLDN18.2 positive advanced gastric/gastroesophageal junction cancer (GC/GEJ).

The first patient was enrolled at the Beijing Cancer Hospital in China. 

GC/GEJ patients who have failed a minimum of two previous lines of treatments will be part of the trial.

An autologous CAR T-cell product against the protein Claudin18.2 (CLDN18.2), CT041 is being analysed to treat CLDN18.2 positive solid tumours with an initial focus on GC/GEJ and pancreatic cancer (PC).

The latest development comes after the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China granted approval to begin the trial in GC/GEJ patients. 

The trial will analyse the safety and efficacy of CT041 to treat advanced GC/GEJ patients.

CT041 is claimed to be the only CLDN18.2-targeting CAR T-cell product candidate to enter a Phase II trial for solid tumour treatment.

It also showed favourable safety in ongoing trials.

The CAR T-cell therapy candidate obtained the US Food and Drug Administration’s (FDA) Orphan Drug designation and Orphan Medicinal Product designation from the European Medicines Agency to treat GC/GEJ and advanced GC in 2020 and 2021. 

Apart from the confirmatory trial in China, CARsgen commenced a Phase Ib trial of the product to treat advanced GC/GEJ and PC in China and another Phase Ib trial for advanced gastric or pancreatic adenocarcinoma in North America.

The company plans to carry out a pivotal Phase II trial in North America this year.

CARsgen Therapeutics founder, board chairman, CEO and chief scientific officer Dr Zonghai Li said: “In the following clinical trials, we will further explore the efficacy and safety of CT041 in the treatment of advanced gastric/gastroesophageal junction cancer, as well as pancreatic cancer.

“We hope that CT041, a potential first-in-class CAR T-cell therapy, could make considerable progress and meet the unmet medical needs as soon as possible.”

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Free Whitepaper
img

Secure the cell therapy supply chain from bench to bedside

The development of cell therapies is changing healthcare, delivering new hope to thousands of patients around the world. The vein-to-vein workflow for these therapies, however, is not without challenges, many of which will increase as we scale up to treat more patients. Download this free guide from Cytiva to learn more about the challenges and risks associated with the cryogenic supply chain for cell therapies, and how supply chain disruptions can best be mitigated.
by Cytiva Thematic

By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU