NCT06878248TerminatedPhase 1
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Reason given: Business Decision
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 6 Mar 2025
- Start date
- 17 Apr 2025
- Primary completion date
- 9 Apr 2026
- Lead sponsor
- Calibr, a division of Scripps Research
- NCT number
- NCT06878248
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of a clinically significant infection within 4 weeks prior to consent
- Prior allogeneic stem cell transplant
- Prior lentiviral- or retroviral-based therapy including CAR-T cell therapy
- Prior lymphodepleting or T-cell cytotoxic therapy within 3 months of enrollment
- Subjects receiving attenuated vaccines within 4 weeks of consent or need for live vaccine within 12 months of starting study therapy
- Subjects with a prior history of or concurrent malignancy whose natural history or treatment has the potential to interfere with either the safety or efficacy assessment of the investigational regimen
Other illness
- Active bacterial, viral, and/or fungal infection
- History of significant cardiovascular conditions within the past 6 months
Who the study is looking for
- Refractory or relapsed locally advanced or metastatic breast cancer
- Exhaused all standard of care therapy options
- Measurable disease at time of screening in accordance with RECIST v1.1 criteria
- Women or men age ≥18 years of age at time of consent
- ECOG performance status 0 or 1
- Must provide a biopsy sample obtained during the screening period, following the end of the most recent prior line of therapy
- Adequate hematological, renal, and liver function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Augusta University Medical Center | Augusta | United States | Unknown status |
| Roswell Park Cancer Institute | Buffalo | United States | Unknown status |
| University of Virginia | Charlottesville | United States | Unknown status |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | United States | Unknown status |
| Fred Hutchinson Cancer Center | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.