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This study will open for enrollment soon. Please contact the study team for more information and check back frequently.
Legend_LB1908-1001 (GI cancers) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called LB-1908 (the study drug) is a safe and effective treatment for different types of gastrointestinal cancers. The study drug is custom-made for each participant from their own white blood cells or T-cells. We collect these cells using a procedure called apheresis.
What is the Condition Being Studied?
Gastric Cancer, Gastroesophageal Junction (GEJ) Cancer, Esophageal Cancer, or Pancreatic Adenocarcinoma
adenocarcinoma
Who Can Participate in the Study?
Adults ages 18-75 who:
- Are diagnosed with gastric cancer, gastroesophageal junction (GEJ) cancer, esophageal cancer, or pancreatic
adenocarcinoma - Test positive for Claudin 18.2 protein
- Have received at least one round of previous treatment for their cancer
For more information about who can join this study, please contact the study team at cci-trialreferrals@duke.edu or 919-681-6468.
Age Group
Adults
What is Involved?
If you choose to join this study, you will:
- Have a tumor biopsy to test for a particular protein (Claudin 18.2) in your body
- Undergo apheresis to collect your white blood cells or T-cells to make the study drug
- Receive lympho-depleting chemotherapy
- Check into the hospital for a stay during which you will get the study drug through an intravenous (IV) infusion
- Have physical exams, blood draws, and give urine samples
- Have imaging scans (CT and/or MRI)
- Have heart tests (ECG)
Study Details
Full Title
A Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:
PRO00114853
NCT:
NCT05539430
Phase
Phase
I
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon