An official website of the United States government
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
Trial Status: active
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.
Inclusion Criteria
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 Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06878248.
Locations matching your search criteria
United States
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not Available
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.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationCalibr, a division of Scripps Research
