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Engineered immune cells take on Hard-to-Treat breast cancer

NCT ID NCT06347068

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Updated 4 times

Summary

This early-stage trial is testing a new type of immune cell therapy called CAR-T cells that target a protein called B7-H3 on triple-negative breast cancer cells. The cells also have a safety switch to stop them if needed. Up to 42 adults whose cancer has returned or not responded to treatment will receive these cells along with two chemotherapy drugs. The main goal is to find a safe dose and understand side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iC9-CAR.B7-H3 T cells (a type of immune cell therapy) given with chemotherapy drugs cyclophosphamide and fludarabine
What this could lead to
If it works, this could point toward a new treatment option for people with triple-negative breast cancer that has come back or not responded to other therapies.
What could go wrong
This is a very early phase 1 trial with only 42 people, so it is mainly checking safety, not effectiveness. The treatment can cause serious side effects like cytokine release syndrome and nerve problems.

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

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

May 2030

An estimate. End dates often move.

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: Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study: 1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative. 2. Age ≥ 18 years at the time of consent. 3. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale)) 4. Histologically confirmed TNBC (ER-, PR-, HER2-negative) 1. ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC) 2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0 Exclusion Criteria: 1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation. 2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Recurrence refractory malignant neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer Relapse Resistant cancer Triple negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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