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ACTIVE NOT RECRUITING
NCT04137536
PHASE1

A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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

DRUG

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