A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT06878248
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-04-17
2028-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Combination product CLBR001 + ABBV461 is administered in ascending dose level cohorts to determine the Optimal Biologic Dose (OBD) of CLBR001 + ABBV-461.
Two Component Product CLBR001 + ABBV-461
Investigational switchable CAR-T cell therapy for breast cancer
Interventions
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Two Component Product CLBR001 + ABBV-461
Investigational switchable CAR-T cell therapy for breast cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Calibr, a division of Scripps Research
OTHER
Responsible Party
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Principal Investigators
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Amy Lightner, MD
Role: STUDY_DIRECTOR
Calibr-Skaggs Institute for Innovative Medicines
Locations
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Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Monica Dherin
Role: backup
Other Identifiers
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CBR-sCAR461-3001
Identifier Type: -
Identifier Source: org_study_id
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