Junshi Bio's GC101, the World’s First Lymphodepletion-Free TIL Therapy, Administers First Dose to Melanoma Patient at Peking University Cancer Hospital

Dec 31, 2023 21:23 CST Updated 21:23

Juncell Therapeutics

Solid Tumor Cell Therapy Developer

Recently, a clinical validation trial for GC101 in the treatment of melanoma was initiated through the collaboration between Juncell Therapeutics and Peking University Cancer Hospital.AlreadyCompletion of the First Subject DosingThe principal investigator (PI) of this clinical project is Professor Guo Jun, Vice Chairman and Secretary General of the CSCO Society, and Chairman of the CSCO Melanoma Expert Committee.

In September 2023, the project was successfully initiated.

In early November 2023, the kick-off meeting was successfully held.

The First Subject Signed the Informed Consent Form on the Day after the Launch Conference

In December 2023, the first subject was dosed.

Suspected recently due to useQing LinPre-treatment regimen leads to subjectsDeath, which in turn triggered clinical trialsPauseUnlike Iovance, the subject enrolled in Juncell Therapeutics' clinical trial received TIL cell infusion prior to the designated stage.Without Intensive Lymphodepletion Pre-treatment, After infusion,No dose of IL-2 combination therapy was used., only inGeneral WardTreatment received domestically，Condition stable, feeling good.Currently, multiple subjects have been successfully enrolled and are awaiting TIL cell infusion.

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About GC101

GC101 is the world's first TIL cell drug that requires no lymphodepletion and no IL-2 injection.Since receiving the implied permission for clinical trials from the National Medical Products Administration (NMPA) in April 2022 (the first batch in China), clinical research targeting various types of advanced solid tumors has been initiated at nearly 10 authoritative tertiary hospitals in regions such as Beijing, Shanghai, and Zhejiang.

Previous clinical data show that GC101 has an objective response rate exceeding 35% for various types of advanced solid tumors.Three patients have achieved complete tumor clearance, with the longest disease-free survival exceeding 2 years.。

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Clinical Recruitment

The Department of Melanoma and Sarcoma Medical Oncology at Peking University Cancer Hospital is the largest treatment center for malignant melanoma in Asia and an internationally authoritative institution. It also serves as the lead unit in drafting China's guidelines for the diagnosis and treatment of melanoma.

Currently, the clinical center is actively recruiting clinical trial participants for GC101 in the treatment of advanced melanoma.Subjects who successfully sign the informed consent form can participate in this clinical trial for free.

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