Assessing a new CAR-T therapy for advanced 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
This study is testing a new CAR-T therapy combined with an adapter molecule to see if it can help people with advanced breast cancer who have run out of other treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Calibr, a division of Scripps Research Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06878248 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the combination of CLBR001, a switchable CAR-T cell therapy, and ABBV-461, an adapter molecule, for patients with locally advanced or metastatic breast cancer. Participants will receive a single infusion of CLBR001 followed by cycles of ABBV-461, with regular assessments to monitor safety and treatment response. The study aims to establish the safety, efficacy, and optimal dosing of this novel therapy in patients who have exhausted standard treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults with refractory or relapsed locally advanced or metastatic breast cancer who have exhausted all standard treatment options.
Not a fit: Patients with active infections, prior CAR-T therapy, or significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced breast cancer who have limited alternatives.
How similar studies have performed: While CAR-T therapies have shown promise in other cancers, this specific combination approach is novel and has not been extensively tested in breast cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Alex Brooks
- Email: abrooks@scripps.edu
- Phone: 858-242-1130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.