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

NCT06878248 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CBR-sCAR461-3001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of subjects with adverse events as assessed by CTCAE v5.0 and ASTCT consensus grading criteria for CRS and ICANS

  To assess the safety and tolerability in subjects by evaluating the frequency, relatedness, severity and duration of adverse events, as assessed by CTCAE v5.0 and ASTCT consensus grading criteria for CRS and ICANS.

  To 1-year post administration of CLBR001

• Number of subjects with replication competent lentivirus

  To assess the safety and tolerability in subjects by evaluating the number of subjects testing positive for replication competent lentivirus.

  To 1-year post administration of CLBR001

• Number of dose-limiting toxicities as assessed by CTCAE v5.0 and ASTCT consensus grading for CRS and ICANS

  The number of dose-limiting toxicities as assessed by CTCAE v5.0 and ASTCT consensus grading for CRS and ICANS will be used to identify an Optimal Biologic Dose (OBD) of CLBR001 and ABBV-461.

  To 28-days post-first dose of ABBV-461

Secondary Outcomes (8)

• Pharmacodynamics

  To 1-year post administration of CLBR001

• Assess Immunogenicity using Antidrug Antibodies

  To 1-year post administration of CLBR001

• Overall Best Objective Response

  To 1-year post administration of CLBR001

• Disease Control Rate

  To 1-year post administration of CLBR001

• Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : Cmax

  To 1-year post administration of CLBR001

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Combination product CLBR001 + ABBV461 is administered in ascending dose level cohorts to determine the Optimal Biologic Dose (OBD) of CLBR001 + ABBV-461.

Biological: Two Component Product CLBR001 + ABBV-461

Interventions

Two Component Product CLBR001 + ABBV-461 BIOLOGICAL

Investigational switchable CAR-T cell therapy for breast cancer

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Calibr, a division of Scripps Research: lead

Study Sites (5)

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amy Lightner, MD

  Calibr-Skaggs Institute for Innovative Medicines

  STUDY DIRECTOR

Central Study Contacts

Alex Brooks

CONTACT

858-242-1130; abrooks@scripps.edu

Jessica Greene

CONTACT

7163907899; jegreene@scripps.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)