RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-17
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06878248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Refractory or relapsed locally advanced or metastatic breast cancer
  2. * Exhaused all standard of care therapy options
  3. * Measurable disease at time of screening in accordance with RECIST v1.1 criteria
  4. * Women or men age ≥18 years of age at time of consent
  5. * ECOG performance status 0 or 1
  6. * Must provide a biopsy sample obtained during the screening period, following the end of the most recent prior line of therapy
  7. * Adequate hematological, renal, and liver function
  1. * History of a clinically significant infection within 4 weeks prior to consent
  2. * Active bacterial, viral, and/or fungal infection
  3. * Prior allogeneic stem cell transplant
  4. * Prior lentiviral- or retroviral-based therapy including CAR-T cell therapy
  5. * Prior lymphodepleting or T-cell cytotoxic therapy within 3 months of enrollment
  6. * Subjects receiving attenuated vaccines within 4 weeks of consent or need for live vaccine within 12 months of starting study therapy
  7. * History of significant cardiovascular conditions within the past 6 months
  8. * 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

Contacts and Locations

Study Contact

Alex Brooks
CONTACT
858-242-1130
abrooks@scripps.edu
Jessica Greene
CONTACT
7163907899
jegreene@scripps.edu

Principal Investigator

Chan Beals, MD, PhD
STUDY_DIRECTOR
Calibr-Skaggs Institute for Innovative Medicines

Study Locations (Sites)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Calibr, a division of Scripps Research

  • Chan Beals, MD, PhD, STUDY_DIRECTOR, Calibr-Skaggs Institute for Innovative Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-17
Study Completion Date2028-11

Study Record Updates

Study Start Date2025-04-17
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • CAR-T therapy
  • metastatic breast cancer
  • locally advanced breast cancer
  • malignant neoplasm of breast
  • Triple Negative Breast Cancer
  • hormone receptor positive breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer Metastatic
  • Locally Advanced Breast Cancer (LABC)
  • Malignant Neoplasm of Breast
  • Triple Negative Breast Cancer (TNBC)
  • Hormone Receptor-Positive Breast Cancer
  • HER2 + Breast Cancer