CLBR001 + ABBV-461 for Breast Cancer

Recruiting at 2 trial locations

Overseen By Alex Brooks

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Calibr, a division of Scripps Research

Must not be taking: Vaccines, T-cell therapy

Disqualifiers: Infection, Cardiovascular conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for breast cancer that has spread or cannot be surgically removed. The researchers aim to test the safety and effectiveness of two experimental treatments, CLBR001 and ABBV-461, when used together. They seek to determine the optimal doses. This trial may suit individuals whose breast cancer has recurred or has not responded to other treatments. Participants should have tried all standard treatments and still have measurable disease. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have had certain therapies like T-cell cytotoxic therapy within 3 months before joining. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CLBR001 and ABBV-461 are part of a new cancer treatment called switchable CAR-T therapy. This treatment remains under study, so information about its safety in humans is limited. The primary goal of this early trial is to assess its safety.

In early trials, researchers carefully monitor treatments like this for side effects. They administer the treatment to a small group and adjust doses to determine the safest amount, identifying any serious side effects or problems.

As a new treatment, detailed reports on patient tolerance are not yet available. However, early trials are designed to quickly identify safety concerns. While treatments approved for other conditions might offer some reassurance, this specific combination is still under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for breast cancer, which often include chemotherapy, hormone therapy, and targeted therapies, CLBR001 + ABBV-461 is unique because it combines two agents to explore a new approach in targeting cancer cells. Researchers are excited about this combination because it aims to determine the Optimal Biologic Dose, potentially enhancing effectiveness while minimizing side effects. This innovative approach could offer a more precise and tailored treatment option, which is a promising advancement in the fight against breast cancer.

What evidence suggests that CLBR001 + ABBV-461 could be an effective treatment for breast cancer?

Research has shown that the combination of CLBR001 and ABBV-461, which participants in this trial will receive, is a new treatment aimed at targeting breast cancer cells more precisely. This therapy uses a special type of T cell that can adapt to better attack cancer while sparing healthy cells. Early studies suggest this method could effectively treat solid tumors, such as those in breast cancer. Although still under investigation, this treatment is designed to enhance the immune system's ability to fight cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

Chan Beals, MD, PhD

Principal Investigator

Calibr-Skaggs Institute for Innovative Medicines

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic breast cancer that has not responded to standard treatments. Participants must have measurable disease, be in good physical condition (ECOG status 0 or 1), and provide a biopsy sample. They should also have proper blood, kidney, and liver function.

Inclusion Criteria

My breast cancer has returned or didn't respond to treatment.

I have tried all standard treatments available for my condition.

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of CLBR001 cells followed by cycles of ABBV-461

4 weeks

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-461
• CLBR001

Trial Overview The study tests CLBR001 cells combined with ABBV-461 drug cycles on patients with advanced breast cancer. It aims to find the safest and most effective dose while monitoring how well the treatment works and its safety through regular check-ups.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Calibr, a division of Scripps Research

Lead Sponsor

Trials

9

Recruited

400+

Published Research Related to This Trial

Triple negative breast cancer (TNBC) is a challenging type of breast cancer that does not respond to hormone therapies or HER2-targeted treatments, leading to limited options and poorer survival rates compared to other breast cancer types.

Several targeted therapies, including PARP inhibitors like olaparib and antiangiogenic agents like bevacizumab, are currently being tested in clinical trials, showing promising results that could improve treatment outcomes for TNBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple negative breast cancer: unmet medical needs. Pal, SK., Childs, BH., Pegram, M.[2021]

Oncolytic adenoviruses (OAds) represent a promising new therapeutic strategy for treating triple-negative breast cancer (TNBC), which is particularly aggressive and often resistant to standard treatments. Preclinical studies have shown that OAds can selectively target and destroy cancer cells while sparing normal cells, enhancing the potential for improved patient outcomes.

Combining OAds with existing treatments, such as PARP inhibitors like Olaparib and immune checkpoint antibodies, has demonstrated enhanced anti-tumor effects, suggesting that these combinations could lead to more effective therapies for women with TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Triple Negative Breast Cancer With Oncolytic Adenoviruses. Green-Tripp, G., Nattress, C., Halldén, G.[2022]

A novel oncolytic virus-infected cell vaccine (ICV) using a prime-boost strategy showed improved survival in mice with aggressive triple negative breast cancer (TNBC), indicating potential efficacy for this hard-to-treat cancer subtype.

Combining early surgical resection of tumors with the prime-boost vaccination significantly enhanced overall survival and immune memory responses, suggesting a promising therapeutic approach for TNBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterologous prime-boost cellular vaccination induces potent antitumor immunity against triple negative breast cancer. Niavarani, SR., St-Cyr, G., Daniel, L., et al.[2023]

Immune checkpoint blockade (ICB) targeting PD-1 or PD-L1 has shown significant clinical activity in breast cancer, particularly in the triple-negative subtype and in earlier treatment lines, with some patients experiencing durable responses even in metastatic disease.

Current research is focused on enhancing the effectiveness of ICB by converting 'cold' tumors into 'hot' tumors through strategies that improve the tumor microenvironment, expand anti-tumor T cells, and enhance antigen presentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of immune checkpoint blockade in breast cancer. Pellegrino, B., Tommasi, C., Cursio, OE., et al.[2022]

Anti-PD-1 and anti-PD-L1 antibodies show modest response rates as standalone treatments for metastatic breast cancer, but they are generally well tolerated and can provide significant, lasting benefits for some patients.

These antibodies can be safely combined with various systemic therapies, including chemotherapy and targeted therapies, as well as radiotherapy, suggesting potential for enhanced effectiveness in treating metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer. Page, DB., Bear, H., Prabhakaran, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06878248

NCT06878248 | A Study to Assess CLBR001+ABBV-461 in ... 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.

2. scripps.edu scripps.edu/news-and-events/press-room/2025/20250617-calibr-scart-cancer.html

Calibr-Skaggs doses first patient with switchable CAR-T ... CLBR001 + ABBV-461 is a novel, investigational, two-part, switchable chimeric antigen T cell (sCAR-T) immunotherapy designed to treat solid tumors.

3. ecancer.org ecancer.org/en/news/26637-study-doses-first-patient-with-switchable-car-t-cell-therapy-in-a-phase-1-trial-for-metastatic-breast-cancer

Study doses first patient with switchable CAR-T cell therapy ... The clinical trial testing CLBR001 + ABBV-461 is now underway in the US. CLBR001 + ABBV-461 is being developed in collaboration with AbbVie.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02228

A Study to Assess CLBR001+ABBV-461 in Subjects With ... 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.

5. cancer.iu.edu cancer.iu.edu/patients/clinical-trials/65221

CTO-CBR-SCAR461-3001: Clinical Trial Information A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Combination of CLBR001, ...

6. trialx.com trialx.com/clinical-trials/listings/297089/a-study-to-assess-clbr001abbv-461-in-subjects-with-locally-advanced-or-metastatic-breast-cancer/

A Study to Assess CLBR001+ABBV-461 ... The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast ...