NCT06878248

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

CLBR001 + ABBV-461 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR-T product (CLBR001, the switchable CAR-T cell \[sCAR-T\]) and ABBV-461 (the "switch" biologic molecule). ABBV-461 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.

Conditions

• Breast Cancer Metastatic
• Locally Advanced Breast Cancer (LABC)
• Malignant Neoplasm of Breast
• Triple Negative Breast Cancer (TNBC)
• Hormone Receptor-Positive Breast Cancer
• HER2 + Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Two Component Product CLBR001 + ABBV-461	Investigational switchable CAR-T cell therapy for breast cancer

Timeline

• Start date: 2025-04-17
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-03-14
• Last updated: 2026-04-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study