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Experimental combo therapy for advanced breast cancer tested in small early trial

NCT ID NCT06878248

Disease control Sponsor: Calibr, a division of Scripps Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new treatment for people with advanced breast cancer that had stopped responding to standard therapies. The treatment combined a patient's own engineered immune cells (CLBR001) with an antibody drug (ABBV-461). The study aimed to find the safest dose and check for side effects, but it was terminated early after enrolling only 10 participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Apr 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma hormone receptor-positive breast cancer triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer, metastatic HER2 + breast cancer Hormone receptor-positive breast cancer Locally advanced breast cancer (LABC) Malignant neoplasm of breast Triple negative breast cancer (TNBC)

Contacts and locations

Locations

  • Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.