ATLCAR.CD138 T Cells for Multiple Myeloma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you must stop all current medications. However, you must stop taking corticosteroids at least 48 hours before lymphodepleting chemotherapy and systemic chemotherapy at least 14 days before lymphodepletion. Radiation therapy should be stopped at least 7 days before lymphodepletion. Please consult with your doctor for specific guidance on other medications.
Will I have to stop taking my current medications?
The trial requires participants to stop taking systemic corticosteroids at doses of 10mg prednisone daily or higher at least 48 hours before starting lymphodepleting chemotherapy. Systemic chemotherapy must be stopped at least 14 days before lymphodepletion, and radiation therapy must be stopped at least 7 days before. Other medications are not specifically mentioned, so it's best to discuss with your doctor.
What data supports the idea that ATLCAR.CD138 T Cells for Multiple Myeloma is an effective treatment?
The available research shows that ATLCAR.CD138 T Cells, a type of treatment for multiple myeloma, have shown promising results. For example, a study using a dual-targeting approach with CD138 and CD38 antigens demonstrated a significant improvement in survival for mice with multiple myeloma, with treated mice living an average of 97 days compared to 31 days for untreated mice. This suggests that ATLCAR.CD138 T Cells can effectively target and fight multiple myeloma cells, offering a potential new option for patients who have not responded to other treatments.12345
What data supports the effectiveness of the treatment ATLCAR.CD138 T Cells for Multiple Myeloma?
Research shows that CAR T cell therapy, which includes targeting antigens like CD138, has shown promising results in treating multiple myeloma. Studies have demonstrated that dual-targeting CAR T cells, such as those targeting CD138, can effectively fight multiple myeloma cells and improve survival in experimental models.12345
What safety data is available for ATLCAR.CD138 T Cells in treating multiple myeloma?
The safety data for CAR T-cell therapies targeting multiple myeloma, including those targeting CD138, indicate that common toxicities include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxic syndrome (ICANS). CRS of grades 1-2 occurred in a significant number of patients, with some experiencing grade ≥3. Efforts to improve safety include optimizing CAR design and incorporating safety systems like suicide genes. Dual-antigen targeting, such as CD138/CD38, has shown increased specificity and reduced off-target toxicity, suggesting a potentially safer profile for these therapies.34678
What safety data exists for ATLCAR.CD138 T Cells in humans?
CAR T-cell therapies, including those targeting CD138, have shown potential in treating multiple myeloma, but they can cause side effects like cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage). These side effects vary in severity, with some patients experiencing mild symptoms and others facing more serious complications.34678
Is the treatment CAR138 T Cells a promising treatment for multiple myeloma?
Yes, CAR138 T Cells are a promising treatment for multiple myeloma. They specifically target cancer cells, showing the ability to eliminate tumor cells effectively in both lab and animal studies. This treatment has shown potential to be a safe and effective option for patients with relapsed or hard-to-treat multiple myeloma.12389
How is the ATLCAR.CD138 T Cells treatment different from other treatments for multiple myeloma?
The ATLCAR.CD138 T Cells treatment is unique because it targets the CD138 protein on myeloma cells, which is different from the more common target, BCMA. This approach may help treat patients who do not respond to BCMA-targeted therapies, offering a new option for those with relapsed or refractory multiple myeloma.12389
What is the purpose of this trial?
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat subjects with cancers. They both have shown promise, but neither alone has been sufficient to cure most subjects. This study is designed to combine both T cells and antibodies to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD138 antigen (CAR138 T cells).In previous studies, it has been shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying the subject's genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD138. This antibody floats around in the blood and can detect and stick to cancer cells called multiple myeloma cells because they have a substance on the outside of the cells called CD138. Anti-CD138 antibodies have been used to treat people with multiple myeloma, but have not been strong enough to cure most subjects. For this study, the anti-CD138 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. Only the part of the antibody that sticks to the multiple myeloma cells is attached to the T cells instead of the entire antibody. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD138 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.
Research Team
Sascha Tuchman, MD, MHS
Principal Investigator
Assoc. Professor, Dir. of the UNC MM and Amyloidosis Program, UNC LCCC
Eligibility Criteria
This trial is for adults over 18 with relapsed or refractory multiple myeloma, who've had at least three prior chemotherapy treatments and are not eligible for or have declined a stem-cell transplant. Participants need to be in stable condition without infections, serious heart issues, or other cancers. They must agree to use contraception if necessary and comply with study procedures.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Cell Procurement
Up to 300 mL total of peripheral blood will be obtained from subjects for cell procurement. In subjects with a low CD3 count, a leukopheresis may be performed.
Lymphodepletion
Lymphodepletion regimen consisting of Cyclophosphamide and Fludarabine administered daily over 3 consecutive days.
CAR138 T-cell Administration
Autologous CAR138 T-cells administered 2-14 days following lymphodepletion via intravenous injection.
Safety Monitoring
Subjects monitored for dose limiting toxicities and safety evaluation for at least 2 weeks following CAR138 T-cell infusion.
Follow-up
Subjects are monitored for safety and effectiveness after treatment, including evaluation of progression free survival, overall survival, and replication-competent retrovirus monitoring.
Treatment Details
Interventions
- CAR138 T Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Baylor College of Medicine
Collaborator
University Cancer Research Fund at Lineberger Comprehensive Cancer Center
Collaborator