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
New breast cancer combo therapy trial seeks patients with advanced disease
Plain English Summary
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer is a Phase 1 clinical trial sponsored by Calibr, a division of Scripps Research studying 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. This trial tests a new combination therapy (CLBR001 and ABBV-461) for breast cancer. It is for patients with locally advanced or metastatic breast cancer who have not responded to standard treatments. Participation involves receiving an infusion of CLBR001 cells followed by cycles of ABBV-461, with regular safety and response checks. Alternative treatments may include other chemotherapy, hormone therapy, or targeted therapies depending on the cancer type. The trial aims to enroll 20 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with breast cancer that has spread or cannot be treated locally. Must have tried all standard treatment options and have measurable disease. Must be 18 years or older with good general health (ECOG 0 or 1). Cannot have active infections, recent stem cell transplants, or prior CAR-T cell therapy. This trial is studying 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, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes will measure how safe the combination therapy is by tracking side effects and specific reactions like cytokine release syndrome and neurotoxicity. The specific primary outcome measures are: Number of subjects with 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 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 (To 28-days post-first dose of ABBV-461). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial addresses a critical need for new treatments for patients with advanced breast cancer who have exhausted all standard options. This research targets 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, where improved treatment options are needed.
Investor Insight
This Phase 1 trial is an early-stage investigation into a novel cell and antibody combination, representing a potential new therapeutic avenue in a large market, with success in this trial potentially Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of this new combination therapy. Understand what side effects might occur and how they will be managed. Be prepared for regular clinic visits for infusions, tests, and monitoring. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 20 participants
Interventions
- BIOLOGICAL: Two Component Product CLBR001 + ABBV-461 — Investigational switchable CAR-T cell therapy for breast cancer
Primary Outcomes
- Number of subjects with 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 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 (To 28-days post-first dose of ABBV-461)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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
Trial Locations
- Augusta University Medical Center, Augusta, Georgia, United States
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
- Roswell Park Cancer Institute, Buffalo, New York, United States
- University of Virginia, Charlottesville, Virginia, United States
- Fred Hutchinson Cancer Center, Seattle, Washington, United States
Frequently Asked Questions
What is clinical trial NCT06878248?
NCT06878248 is a Phase 1 INTERVENTIONAL study titled "A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer." It is currently active, not recruiting and is sponsored by Calibr, a division of Scripps Research. The trial targets enrollment of 20 participants.
What conditions does NCT06878248 study?
This trial investigates treatments for 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. The primary condition under study is Breast Cancer Metastatic.
What treatments are being tested in NCT06878248?
The interventions being studied include: Two Component Product CLBR001 + ABBV-461 (BIOLOGICAL). Investigational switchable CAR-T cell therapy for breast cancer
What does Phase 1 mean for NCT06878248?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT06878248?
This trial is currently "Active, Not Recruiting." It started on 2025-04-17. The estimated completion date is 2026-06.
Who is sponsoring NCT06878248?
NCT06878248 is sponsored by Calibr, a division of Scripps Research. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06878248?
The trial aims to enroll 20 participants. The trial status is active, not recruiting.
How is NCT06878248 designed?
This is a interventional study, uses na allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT06878248?
The primary outcome measures are: Number of subjects with 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 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 (To 28-days post-first dose of ABBV-461). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06878248 being conducted?
This trial is being conducted at 5 sites, including Augusta, Georgia; Indianapolis, Indiana; Buffalo, New York; Charlottesville, Virginia and 1 more sites (United States).
Where can I find official information about NCT06878248?
The official record for NCT06878248 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06878248. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06878248 testing in simple terms?
This trial tests a new combination therapy (CLBR001 and ABBV-461) for breast cancer. It is for patients with locally advanced or metastatic breast cancer who have not responded to standard treatments.
Why is this trial significant?
This trial addresses a critical need for new treatments for patients with advanced breast cancer who have exhausted all standard options.
What are the potential risks of participating in NCT06878248?
The main risks involve side effects from the cell therapy and antibody, including fever, fatigue, and potential immune reactions. Specific risks include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which can cause flu-like symptoms or neurological issues. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06878248?
Ask your doctor about the potential benefits and risks of this new combination therapy. Understand what side effects might occur and how they will be managed. Be prepared for regular clinic visits for infusions, tests, and monitoring. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06878248 signal from an investment perspective?
This Phase 1 trial is an early-stage investigation into a novel cell and antibody combination, representing a potential new therapeutic avenue in a large market, with success in this trial potentially This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving an infusion of CLBR001 cells followed by cycles of ABBV-461, with regular safety and response checks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.