PD-1 Blockade + Dendritic Cell Fusion Vaccine + CT-011 for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatments for multiple myeloma, a type of blood cancer. Researchers aim to determine if combining a monoclonal antibody called CT-011 with the Dendritic Cell Fusion Vaccine can more effectively prevent or delay cancer recurrence after autologous stem cell transplantation (ASCT). Participants are divided into two groups: one receives only CT-011, while the other receives both the vaccine and CT-011. Individuals with multiple myeloma who can undergo high-dose chemotherapy and have a specific disease pattern are suitable candidates for the trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CT-011, a monoclonal antibody treatment, has been studied in people with multiple myeloma. Studies indicate it is generally safe, though its effectiveness can vary. This treatment aims to help the immune system fight cancer cells.
The dendritic cell fusion vaccine, another treatment in this trial, has also been tested in people with multiple myeloma. It was well-tolerated and helped strengthen the immune response against the cancer.
Both treatments have demonstrated promising safety profiles, as they did not cause serious side effects in previous studies. This is encouraging for those considering joining the trial, suggesting the treatments are likely safe based on past research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of PD-1 blockade with dendritic cell fusion vaccine and CT-011 for treating multiple myeloma because it introduces an innovative approach to enhance the immune system's response to cancer cells. Unlike the standard treatments, which often include chemotherapy and stem cell transplants, CT-011 is a monoclonal antibody designed to block PD-1, a protein that helps cancer cells evade the immune system. The dendritic cell fusion vaccine works by stimulating the body's own immune cells to recognize and attack myeloma cells more effectively. This combination aims to boost the immune system's ability to fight the cancer, potentially leading to more durable responses and improved outcomes for patients.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that CT-011, a new type of antibody, could help treat multiple myeloma. It boosts the activity of T-cells, immune cells that find and attack cancer cells. CT-011 also enhances the function of natural killer cells, another type of immune cell, to combat myeloma cells. In this trial, participants in Group 1 will receive CT-011 alone.
Group 2 will test another treatment, the dendritic cell fusion vaccine, which helps the immune system target and fight cancer. Previous studies found that most patients experienced an immune response, and their disease stopped progressing after receiving this vaccine. Participants in Group 2 will receive both the dendritic cell fusion vaccine and CT-011. Together, these treatments aim to strengthen the body’s defense against multiple myeloma.14567Who Is on the Research Team?
David Avigan, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with multiple myeloma who are candidates for high-dose chemotherapy and stem cell rescue. They must have a certain level of heart function, specific lab results, measurable disease, and no serious illnesses like significant heart disease or active infections. Pregnant women or those with autoimmune diseases (except stable hypothyroidism) can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Therapy and Stem Cell Transplantation
Participants receive standard therapy to reduce multiple myeloma cells, followed by high dose chemotherapy and autologous stem cell transplantation
Treatment
Participants receive 3 infusions of CT-011 at 6 week intervals. Group 2 also receives Dendritic Cell Fusion Vaccine one week after each CT-011 infusion
Follow-up
Participants are monitored with blood tests, urine tests, bone marrow aspirate/biopsy, and skeletal survey at one, three, and six months following the last study treatment
What Are the Treatments Tested in This Trial?
Interventions
- CT-011
- Dendritic Cell Fusion Vaccine
Trial Overview
The study is testing the safety and effect of CT-011 alone and combined with a dendritic cell fusion vaccine after autologous stem cell transplantation in multiple myeloma patients. It aims to see if this combination helps prevent or delay cancer recurrence better than standard therapy.
How Is the Trial Designed?
2
Treatment groups
Active Control
Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals.
Vaccination with DC/myeloma fusion cells will be given 1-3 months following autologous transplant. Vaccination will be given at 6 weeks intervals. The monoclonal antibody CT-011 will be given 1 week following each vaccination. 3 doses of CT-011 will be given at 6 week intervals.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
United States Department of Defense
Collaborator
Brigham and Women's Hospital
Collaborator
Dana-Farber Cancer Institute
Collaborator
Rambam Health Care Campus
Collaborator
Gateway for Cancer Research
Collaborator
Published Research Related to This Trial
Citations
PD-1 blockade by CT-011, anti PD-1 antibody, enhances ex ...
We demonstrate that PD-1 expression is increased in T cells of patients with active myeloma, and that CT-011 enhances activated T cell responses following DC/ ...
The PD-1/PD-L1 axis modulates the natural killer cell ...
We demonstrate that CT-011, a novel anti–PD-1 antibody, enhances human NK-cell function against autologous, primary MM cells, seemingly through effects on NK- ...
PD-1 Blockade + Dendritic Cell Fusion Vaccine + CT-011 ...
This combination aims to enhance the body's immune response against multiple myeloma by activating T-cells to better recognize and attack cancer cells.
Promises and Pitfalls in the Use of PD-1/PD-L1 Inhibitors ...
This review aims to analyze the available preclinical and clinical data on the role of PD-1/PD-L1 inhibitors in MM therapy, focusing on available preliminary ...
Immune checkpoint inhibitors for multiple myeloma ...
PD-1 blockade by CT-011, anti-PD-1 antibody, enhances ex vivo T-cell responses to autologous dendritic cell/myeloma fusion vaccine. J ...
Immune checkpoint blockade in hematological malignancies
Multiple early phase studies showed safety but low efficacy of PD-1 ... associated with clinical outcomes of relapsed/refractory multiple myeloma ...
harnessing the immune system to battle multiple myeloma
By blocking the combination of PD-1 and PD-L1, inhibitors restore T-cell killing function against myeloma cells [36]. Furthermore, studies have ...
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