Status:
RECRUITING
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Calibr, a division of Scripps Research
Conditions:
Breast Cancer Metastatic
Locally Advanced Breast Cancer (LABC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 molec...
Eligibility Criteria
Inclusion
- 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
Exclusion
- History of a clinically significant infection within 4 weeks prior to consent
- Active bacterial, viral, and/or fungal infection
- 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
- History of significant cardiovascular conditions within the past 6 months
- 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
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06878248
Start Date
April 17 2025
End Date
November 1 2028
Last Update
September 17 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
University of Virginia
Charlottesville, Virginia, United States, 22908