Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Calibr, a division of Scripps Research
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
