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A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
Sponsor: Calibr, a division of Scripps Research
Summary
The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer. The goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses. Patients will be administered a single infusion of CLBR001 cells followed by cycles of ABBV-461 with regular assessments of safety and disease response to treatment.
Official title: A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Combination of CLBR001, an Engineered Autologous T Cell Product, and ABBV-461, an Antibody-Based Biologic, in Subjects With Locally Advanced or Metastatic Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-04-17
Completion Date
2026-06
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Two Component Product CLBR001 + ABBV-461
Investigational switchable CAR-T cell therapy for breast cancer
Locations (5)
Augusta University Medical Center
Augusta, Georgia, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States