Yimufeng Bio Launches Phase II Trial of IMC002 CAR-T Therapy for CLDN18.2-Positive Advanced Gastric Cancer
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
Dear Subject Friends:
A "Multicenter, Randomized, Controlled, Open-label Phase II Clinical Study Comparing the Efficacy and Safety of IMC002 versus Investigator's Choice of Treatment in Adult Subjects with Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing CLDN18.2 who Have Previously Received at Least Two Lines of Therapy" is currently underway. IMC002 is a CAR-T product. The study is sponsored by Immunofoco, and Professor Jianming Xu from the First Medical Center of the Chinese People's Liberation Army General Hospital serves as the leading principal investigator, with the trial being conducted simultaneously across multiple hospitals in China. This clinical study complies with the Good Clinical Practice guidelines and relevant regulatory requirements and has been approved by the National Medical Products Administration (Approval No. CTR20252202).
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Main Inclusion and Exclusion Criteria:
1) At least 18 years old when randomized, male or female.
2) Patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, which was previously confirmed by histology or cytology as inoperable, who experience disease progression within 6 months after the completion of neoadjuvant/adjuvant therapy, are also considered to have failed first-line treatment.
3) Have failed at least two lines of systemic treatment (radiographic progression or clinical symptom deterioration; intolerance, after being fully assessed by the investigator, is also eligible for enrollment).
4) It is expected to obtain tumor tissue samples from subjects (primary or metastatic, archived or newly collected), with positive histological staining for CLDN18.2 in tumor tissue samples tested by the central laboratory (defined as a tumor cell positivity rate ≥40% and staining intensity ≥2+).
If you meet the above conditions and are willing to participate in this study, after your written consent, the research doctor will conduct a detailed evaluation of your condition and perform laboratory tests related to the trial. If, after evaluation, you meet all the criteria for participating in this study, you will be able to enter the study to receive treatment with the trial drug.
If you are interested in learning more about the study, you can contact the researchers through the following methods.
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Contact Information
