CAR T-Cell Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called GCAR1, a type of cell therapy, to assess its safety and effects on certain advanced cancers, including triple-negative breast cancer (which lacks certain receptors). The goal is to determine the highest dose that can be administered without severe side effects. It targets individuals in Canada with specific cancers that lack curative treatment options and have progressed after previous treatments. Participants should have a type of cancer that tests positive for high levels of a protein called GPNMB. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it mentions that adequate washout (time without taking certain medications) must be followed per protocol. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that CAR T-cell therapies, such as GCAR1, are beginning to work for individuals with hard-to-treat solid tumors, including certain types of breast cancer. These therapies use specially modified cells to target cancer cells. Safety remains a major focus, and studies aim to determine the optimal dose that avoids serious side effects.
In previous cases, CAR T-cell treatments have generally been well-tolerated, though some side effects can occur. Common issues include fever, low blood pressure, and fatigue, while serious side effects remain rare. As this trial is in an early stage, it primarily focuses on safety and determining a safe dosage.
While these therapies appear promising, they are still under investigation. Therefore, it is crucial to weigh the potential benefits against the risks when considering participation in a trial.12345Why do researchers think this study treatment might be promising?
CAR T-Cell Therapy is unique because it reprograms a patient's own immune cells to specifically target and destroy breast cancer cells. Unlike traditional treatments like chemotherapy and hormone therapy, which can affect both healthy and cancerous cells, CAR T-Cell Therapy offers a more targeted approach. This precision reduces damage to healthy tissues and may lead to fewer side effects. Researchers are excited about its potential because of its innovative mechanism that could lead to significant advancements in cancer treatment, offering hope for more effective and personalized cancer care.
What evidence suggests that this treatment might be an effective treatment for breast cancer?
Research has shown that GCAR1, a new type of CAR T-cell therapy studied in this trial, might help the body's immune system find and attack breast cancer cells. Lab tests demonstrated that this treatment can slow cancer growth. Early studies of similar CAR T-cell therapies have shown promising results in treating solid tumors, including some breast cancers unresponsive to other treatments. These therapies target specific features on cancer cells, aiding the immune system in fighting cancer more effectively. While more research is needed, these findings suggest a hopeful future for GCAR1 in breast cancer treatment.12346
Who Is on the Research Team?
Mona Shafey
Principal Investigator
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Are You a Good Fit for This Trial?
This trial is for people in Canada with certain advanced cancers (kidney, breast, or alveolar soft part sarcoma) that can't be cured by surgery or other treatments. Their tumors must have high levels of a protein called GPNMB. Adults over 18 and teens over 15 with measurable disease as per RECIST 1.1 can join if they give consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive increasing doses of GCAR1 CAR-T cell therapy to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GCAR1
Trial Overview
The study tests GCAR1 CAR-T cell therapy's highest safe dose and its effects on specific cancers expressing GPNMB. It includes pre-treatment with Fludarabine and Cyclophosphamide to prepare the body for the CAR-T cells.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
University of Calgary
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
BioCanRx
Collaborator
Citations
GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL ...
Laboratory tests have shown that GCAR1 helps the immune system recognize cancer cells and may help slow down cancer growth.
Advancing breast cancer treatment through dual targeting ...
The effectiveness of dual-targeting CAR-T-cell therapy hinges critically on the selection of combinations of antigen pairs that can overcome ...
3.
onclive.com
onclive.com/view/targeted-car-t-cell-therapies-show-early-efficacy-in-solid-tumors-with-focus-on-mitigating-toxicityTargeted CAR T-Cell Therapies: Early Efficacy Mitigating ...
Several targeted chimeric antigen receptor (CAR) T-cell therapies are beginning to show early signals of efficacy for patients with solid tumors.
CAR-T cell therapy for breast cancer: Current status
CAR-T cells show promise for targeting resistant breast cancer subtypes. CAR-T cells target tumor-specific antigens in breast cancer.
CAR-T cell therapy for cancer: current challenges
Among those patients who received the recommended dose, the 3-year overall survival and event-free survival were 60% and 36%, respectively. The ...
A Safety and Efficacy Study of Allogeneic CAR Gamma ...
A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed/Refractory Solid Tumors · Overview · Trial locations.
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