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About
This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).
Full description
This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C (GCC)-positive advanced gastrointestinal tumors. Subjects who meet the eligibility criteria will receive LCAR-G08 infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.
Enrollment
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Inclusion criteria
Exclusion criteria
Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
Primary purpose
Allocation
Interventional model
Masking
42 participants in 1 patient group
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Central trial contact
Changsong Qi; Lin Shen
Data sourced from clinicaltrials.gov
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