Cancer Clinical Trial
Official title:
A Multicenter, Single-arm, Open-label, Dose-escalation and Dose-expansion Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell WTX212 in Patients With Advanced Malignancies
This phase studies the engineered red blood cells with PD-1 inhibitor pembrolizumab（WTX212）, the natural biological metabolic function of red blood cells can make the carried pembrolizumab directionally distributed in the spleen tissue and activitate T cells, suggesting that this product may solve the problem that PD-1 treatment failure.
The present study has 2 parts. The dose increasing stage is carried out according to the "3+3" increasing principle. A total of 3 dose groups are preset (calculated by the number of red blood cells of the pabolizumab loaded), which are respectively 20 × e10、60 × e10 and 100 × e10。 Subjects with IO resistant advanced solid tumor and recurrent refractory lymphoma were studied. After the subjects passed the screening, blood was taken to prepare the engineered red blood cell WTX212, and the test drug was administered once every 21 days. Subjects completed the collection of PK, PD, biomarkers and immunogenicity samples during the observation period of dose limiting toxicity (DLT) (within 21 days after the first administration) and the continuous treatment period. After the end of DLT period of the first subject in each dose group, the second subject can be accepted. The subject continues to receive treatment until the subject suffers from intolerable toxicity, or withdraws informed consent, or disease progression, or solid tumor subjects up to 12 months after the first administration (lymphoma subjects can complete up to 6 administration cycles), or the end of the study, or the investigator comprehensively decides to withdraw and start new anti-tumor treatment according to the benefit of the subject, whichever occurs first. ;
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