Breast Cancer MetastaticPhase 1NCT06878248
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
A Phase 1 study testing Two Component Product CLBR001 + ABBV-461 in people with Breast Cancer Metastatic and Locally Advanced Breast Cancer (LABC), run by Calibr, a division of Scripps Research at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC), Malignant Neoplasm of Breast
- What is being tested?
- Two Component Product CLBR001 + ABBV-461
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Apr 2025to 9 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Augusta University Medical Center
Augusta, Georgia, 30912
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Virginia
Charlottesville, Virginia, 22908
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
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
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.
Read the detailed description
CLBR001 + ABBV-461 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR-T product (CLBR001, the switchable CAR-T cell [sCAR-T]) and ABBV-461 (the "switch" biologic molecule). ABBV-461 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.
- 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
- Being tested
- Two Component Product CLBR001 + ABBV-461
- 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
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Component Product CLBR001 + ABBV-461Biological
Investigational switchable CAR-T cell therapy for breast cancer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Two Component Product CLBR001 + ABBV-461 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: To 28-days post-first dose of ABBV-461
Secondary outcomes (8)
Pharmacodynamics
To measure pharmacodynamic response by evaluating concentrations of serum cytokines.
Measured: To 1-year post administration of CLBR001
Assess Immunogenicity using Antidrug Antibodies
To determine Immunogenic response to CLBR001 and ABBV-461 by presence of antidrug antibodies (ADA)
Measured: To 1-year post administration of CLBR001
Overall Best Objective Response
To evaluate anti-tumor activity of CLBR001 + ABBV-461 by assessing Overall (best) objective response by response evaluation criteria in solid tumors by using RECIST v1.1.
Measured: To 1-year post administration of CLBR001
Disease Control Rate
To evaluate anti-tumor activity of CLBR001 + ABBV-461 by assessing Disease Control Rate by using RECIST v1.1.
Measured: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : Cmax
To evaluate the pharmacokinetics (PK) of CLBR001, including expansion and persistence, and ABBV-461 by quantifying CLBR001 cells in peripheral blood and PK parameters of ABBV-461.
Measured: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : Tmax
To evaluate the pharmacokinetics (PK) of CLBR001, including expansion and persistence, and ABBV-461 by quantifying CLBR001 cells in peripheral blood and PK parameters of ABBV-461.
Measured: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : AUC
To evaluate the pharmacokinetics (PK) of CLBR001, including expansion and persistence, and ABBV-461 by quantifying CLBR001 cells in peripheral blood and PK parameters of ABBV-461.
Measured: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : t(1/2)
To evaluate the pharmacokinetics (PK) of CLBR001, including expansion and persistence, and ABBV-461 by quantifying CLBR001 cells in peripheral blood and PK parameters of ABBV-461.
Measured: To 1-year post administration of CLBR001
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start17 Apr 2025
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calibr, a division of Scripps Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, MD, Study director, Calibr-Skaggs Institute for Innovative Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878248
- Sponsor's protocol ID
- CBR-sCAR461-3001
- Status last verified
- May 2026
- First submitted
- 6 Mar 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06878248
- Acronym / sponsor ID
- CBR-sCAR461-3001
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Calibr, a division of Scripps ResearchUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CLBR001 + ABBV-461 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR-T product (CLBR001, the switchable CAR-T cell [sCAR-T]) and ABBV-461 (the "switch" biologic molecule). ABBV-461 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: Two Component Product CLBR001 + ABBV-461Combination product CLBR001 + ABBV461 is administered in ascending dose level cohorts to determine the Optimal Biologic Dose (OBD) of CLBR001 + ABBV-461. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two Component Product CLBR001 + ABBV-461Investigational switchable CAR-T cell therapy for breast cancer | Biological | Dose Escalation |
Primary outcome
Number of subjects with adverse events as assessed by CTCAE v5.0 and ASTCT consensus grading criteria for CRS and ICANS
Time frame: To 1-year post administration of CLBR001
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.
Number of subjects with replication competent lentivirus
Time frame: To 1-year post administration of CLBR001
To assess the safety and tolerability in subjects by evaluating the number of subjects testing positive for replication competent lentivirus.
Number of dose-limiting toxicities as assessed by CTCAE v5.0 and ASTCT consensus grading for CRS and ICANS
Time frame: To 28-days post-first dose of ABBV-461
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.
8 secondary outcomes
Pharmacodynamics
Time frame: To 1-year post administration of CLBR001
Assess Immunogenicity using Antidrug Antibodies
Time frame: To 1-year post administration of CLBR001
Overall Best Objective Response
Time frame: To 1-year post administration of CLBR001
Disease Control Rate
Time frame: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : Cmax
Time frame: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : Tmax
Time frame: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : AUC
Time frame: To 1-year post administration of CLBR001
Evaluate Pharmacokinetics of CLBR001 + ABBV-461 : t(1/2)
Time frame: To 1-year post administration of CLBR001
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer, MD study director
Calibr-Skaggs Institute for Innovative Medicines
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Two Component Product CLBR001 + ABBV-461 in people with Breast Cancer Metastatic and Locally Advanced Breast Cancer (LABC), run by Calibr, a division of Scripps Research at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events as assessed by CTCAE v5.0 and ASTCT consensus grading criteria for CRS and ICANS (time frame: To 1-year post administration of CLBR001). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.