Treating Advanced or Metastatic Breast Cancer with a Type of Immunotherapy Called CAR-T
https://www.facingourrisk.org/research-clinical-trials/study/364/treating-advanced-or-metastatic-breast-cancer-with-a-type-of-immunotherapy-called-car-t
Clinicaltrials.gov identifier:
NCT06878248 (https://clinicaltrials.gov/show/NCT06878248)
Treatment
Phase 1 treatment study for people with advanced solid tumors
Study Contact Information:
Name: Alex Brooks
Phone Number: 858-242-1130
Email: [email protected]
Name: Jessica Greene
Phone Number: 7163907899
Email: [email protected]
About the Study
CAR-T therapy is a type of immunotherapy that uses the patient's own immune cells in order to treat their cancer. With CAR-T therapy, the immune cells are removed from the blood and enhanced in the lab to improve their ability to kill cancer cells. The goal of this clinical trial is to learn the safety and effectiveness of an experimental CAR-T combination known as CLBR001+ABBV-461 for treating people with metastatic breast cancer. Another goal is to learn the best dose of this combination for treating metastatic breast cancer.
What the Study Involves
All participants in the study will receive this experimental CAR-T therapy using two products: CLBR001 + ABBV-461.
CLBR001 is a type of CAR-T cell that can be "switched on" by the agent ABBV-461, which controls the activity of CLBR001. CAR-T cell therapy is a multi-step process:
- Participants' immune cells are collected using a process known as apharesis. Apheresis is a type of blood collection where the blood is removed and filtered to collect the t cells. The other blood components are returned back to the patient through the same blood collection system.
- Participants immune cells are enhanced in the lab, creating CLBR001 cells (a type of CAR-T cell) that have an increased ability to find and kill cancer cells.
- Participants receive a single infusion (injection into the vein) of the CAR-T cells.
- Participants will receive multiple cycles of infusion of ABBV-461. ABBV-461 acts as a "switch" to activate the CAR-T cells.
- Participants will be monitored during the study and will be followed for one year after treatment for side effects, progression or recurrence.
This Study is Open To:
People with the following may be eligible to participate:
- metastatic breast cancer with no further standard-of-care treatment options available.
- measurable disease at time of enrollment.
- must provide a biopsy sample obtained before enrollment and after the latest line of treatment.
- Adequate bone marrow, kidney, and liver function.
This Study is Not Open To:
People with the following may not be eligible to participate:
- previously received a stem-cell transplant.
- previously received CAR-T therapy.
- diagnosed with heart disease.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.