A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

Launched by CALIBR, A DIVISION OF SCRIPPS RESEARCH · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination, CLBR001 and ABBV-461, for patients with locally advanced or metastatic breast cancer. This means it’s looking at how well these two therapies work together and whether they are safe for patients who have already tried other treatments without success. The trial is open to both men and women aged 18 and older who have measurable cancer and have exhausted standard treatment options.

If you participate in this trial, you will receive a single infusion of CLBR001 cells, followed by several cycles of ABBV-461. Throughout the study, your health will be closely monitored to check for any side effects and to see how well the treatment is working. It’s important to note that there are specific criteria to qualify for this trial, such as being in good health overall and not having certain recent infections or prior treatments that might interfere with the study. This trial is currently recruiting participants, so it could be an option if you or a loved one are looking for new treatment opportunities.

Gender

ALL

Eligibility criteria

• 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