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A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.
Official title: Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
7
Start Date
2019-10-17
Completion Date
2026-04
Last Updated
2025-05-15
Healthy Volunteers
No
Interventions
anti-EGFR-bispecific antibody armed activated T-cells
Phase I: * First 3 participants, twice weekly infusions of 10\^10 EGFR BATs infusions * If there is toxicity in 0 or 1 of 3 participants, 3 additional participants will be added to the dose level of up to 10\^10. * If \>/= 2 of 6 participants experience DLTs, then the dose will be reduced to 7.5 x 10\^9 per infusion * If only 0 or 1 participants has toxicity in the first 6, then the study will proceed to enroll in the expansion cohort Expansion cohort: \- 8 infusions of 7.5 x 10\^9 or 10\^10 EGFR BATs in 22 evaluable participants (including the 6 participants treated at the maximum tolerated dose in Phase I)
Locations (2)
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Virginia (Specimen Analysis)
Charlottesville, Virginia, United States