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ACTIVE NOT RECRUITING
NCT06878248
PHASE1

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

Sponsor: Calibr, a division of Scripps Research

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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