A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)
NCT ID: NCT06197178
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2023-12-28
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chimeric Antigen Receptor T cell LCAR-G08 Cells
Each subject will receive LCAR-G08 Cells
LCAR-G08 cells
Prior to infusion of the LCAR-G08, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Interventions
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LCAR-G08 cells
Prior to infusion of the LCAR-G08, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed metastatic colorectal cancers and other advanced gastrointestinal cancers (esophageal cancer, gastric cancer, pancreatic cancer, and small bowel cancer).
* Aged 18 to 70 years, either sex.
* GCC immunohistochemistry (IHC) staining is positive.
* At least one measurable tumor lesion according to RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Expected survival ≥ 3 months.
* Clinical laboratory values meet screening visit criteria.
Exclusion Criteria
* Ever received any treatment targeting GCC.
* Prior antitumor therapy with insufficient washout period.
* Brain metastases.
* Pregnant or lactating women.
* Hepatitis C virus (HCV) antibody-positive or human immunodeficiency virus (HIV) antibody-positive, active syphilis, Epstein-Barr virus (EBV) infected.
* Severe underlying disease.
* Presence of other serious pre-existing medical conditions that may limit patient participation in the study.Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
18 Years
70 Years
ALL
No
Sponsors
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Nanjing Legend Biotech Co.
INDUSTRY
Peking University
OTHER
Responsible Party
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Shen Lin
Professor
Principal Investigators
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Lin Shen
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Lin Shen, MD
Role: primary
Yanshuo Cao, MD
Role: backup
Changsong Qi
Role: primary
Other Identifiers
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LB2301-0001
Identifier Type: -
Identifier Source: org_study_id