A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
NCT06878248 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-03
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.
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
- BIOLOGICAL
-
Two Component Product CLBR001 + ABBV-461
Investigational switchable CAR-T cell therapy for breast cancer
Sponsors & Collaborators
-
Calibr, a division of Scripps Research
lead OTHER
Principal Investigators
-
Chief Medical Officer, MD · Calibr-Skaggs Institute for Innovative Medicines
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-17
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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