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.
Who Can Participate?
Eligibility
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
What is Involved?
Description
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
Nicholas
DeVito
Protocol Number
PRO00114853
NCT ID
NCT05539430
Phase
I
Enrollment Status
Pending Open to Enrollment