CAR T-Cell Therapy and Vaccine for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with high-risk acute lymphoblastic leukemia, a type of blood cancer. The therapy involves engineering T cells (immune cells) to target and destroy cancer cells, known as Anti-CD19-CAR CMV-specific T-lymphocytes, and includes a vaccine to boost the immune response. The trial aims to determine if this combination is safe and effective after a stem cell transplant. Individuals with acute lymphoblastic leukemia that is difficult to treat or has recurred after treatment might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use systemic steroids, and if you have an active autoimmune disease requiring immune suppressive therapy, you may not be eligible.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that CD19-targeted CAR T-cell therapy is generally well-tolerated. Studies have found that this treatment can lead to complete remission in 70%–90% of patients with recurring blood cancers like acute lymphoblastic leukemia. While side effects can occur, the overall safety is promising, with many patients experiencing manageable symptoms.
Previous studies suggest that the CMV-MVA vaccine is safe and helps strengthen the immune system. Participants in trials have tolerated the vaccine well, with few serious side effects reported. It has effectively boosted the body's defense against cytomegalovirus, a common virus that can cause problems in people with weakened immune systems.
Both treatments have shown encouraging safety results. However, this trial is in an early phase, so the complete safety picture is still being studied. Researchers will closely monitor participants for any adverse events as they continue to evaluate these therapies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for acute lymphoblastic leukemia because they use a novel approach known as CAR T-cell therapy. Unlike traditional treatments like chemotherapy and radiation, which broadly target cancer cells, CAR T-cells are engineered to specifically recognize and attack leukemia cells by targeting a protein called CD19 on their surface. Additionally, one of the treatment arms includes a CMV-MVA vaccine, which is given to further stimulate the immune system's response, potentially enhancing the effectiveness of the CAR T-cells. This combination could offer a more precise and powerful approach to eliminating cancer cells while minimizing damage to healthy cells.
What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?
Studies have shown that CD19 CAR-T cell therapy can effectively treat B-cell acute lymphoblastic leukemia. It eliminates residual cancer cells and improves long-term survival. Research indicates that this treatment is generally safe, with manageable side effects. In this trial, some participants will receive CD19 CAR-T cell therapy alone, while others will receive both CD19 CAR-T cell therapy and the CMV-MVA vaccine. The CMV-MVA vaccine aims to strengthen the immune system against cancer cells in patients who have undergone a stem cell transplant. Although still under study, early data suggest it boosts immunity and helps prevent cytomegalovirus reactivation, which is crucial for patient safety post-transplant. Both the CAR-T therapy and the vaccine offer promising ways to combat high-risk leukemia, especially when combined.24678
Who Is on the Research Team?
Ibrahim Aldoss, MD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for high-risk acute lymphoblastic leukemia patients who have undergone a stem cell transplant from a matched related donor. Participants must be eligible for all study procedures and interventions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
HSCT Conditioning and Transplantation
Patients receive HSCT conditioning regimen followed by alloHSCT per standard of care
CAR T Cell Infusion
Patients receive allo CMV-specific CD19-CAR T cells intravenously
Vaccine Administration
Patients receive CMV-MVA triplex vaccine intramuscularly on day 28 and possibly on day 56
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anti-CD19-CAR CMV-specific T-lymphocytes
- Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
Trial Overview
The trial tests the safety and effectiveness of CMV-specific CD19-CAR T cells combined with a CMV-MVA vaccine in treating leukemia post-stem cell transplant. It involves modifying immune cells to target cancer, followed by vaccination to enhance the immune response.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive HSCT conditioning regimen followed by alloHSCT per standard of care. Starting 28-49 days after alloHSCT, patients receive allo CMV-specific CD19-CAR T cells IV over 10-15 minutes on day 0. Patients receive CMV-MVA triplex vaccine IM on day 28 in the absence of DLTs and may receive an additional CMV-MVA triplex vaccine IM on day 56 in the absence of DLTs during the second evaluation period. Patients undergo ECHO or MUGA, blood and optional CSF sample collection and bone marrow biopsy and aspiration throughout the study. Patient may also undergo chest x-ray and lumbar puncture as needed per PI discretion and PET/CT or CT as clinically indicated throughout the study. Additionally, patients with neurological abnormalities at baseline may undergo MRI of brain throughout the study.
Patients receive HSCT conditioning regimen followed by alloHSCT per standard of care. Starting 28-49 days after alloHSCT, patients receive allo CMV-specific CD19-CAR T cells IV over 10-15 minutes on day 0. Patients undergo ECHO or MUGA, blood and optional CSF sample collection and bone marrow biopsy and aspiration throughout the study. Patient may also undergo chest x-ray and lumbar puncture as needed per PI discretion and PET/CT or CT as clinically indicated throughout the study. Additionally, patients with neurological abnormalities at baseline may undergo MRI of brain throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Donor-derived Anti-CD19 CAR T cells GC007g for relapsed or ...
Although chimeric antigen receptor-modified T cells (CAR T) cell therapy has been widely reported in improving the outcomes of B-cell acute lymphoblastic ...
Safety and efficacy of autologous humanized CD19 CAR-T ...
Limited research has evaluated humanized CD19-targeted CAR-T cells (hCART19) in relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).
Effective MRD clearance and long-term survival with CD19 ...
Conclusion: CD19 CAR-T therapy demonstrates highly effective MRD clearance and provides long-term survival benefits with a manageable safety ...
4.
cancer.gov
cancer.gov/research/participate/clinical-trials/intervention/anti-cd19-car-cmv-specific-t-lymphocytesClinical Trials Using Anti-CD19-CAR CMV-specific T- ...
Review the clinical trials studying anti-cd19-car cmv-specific t-lymphocytes on this list and use the filters to refine the results by age and location.
Prominent efficacy and good safety of sequential CD19 ...
Prominent efficacy and good safety of sequential CD19 and CD22 CAR-T therapy in relapsed/refractory adult B-cell acute lymphoblastic leukemia.
CAR T-Cells in Acute Lymphoblastic Leukemia: Current Status ...
Considering that only anti-CD19 CAR T-cells are the currently FDA-approved CAR T-cell therapy for B-ALL, we can classify relapse to either CD19- ...
Donor-derived Anti-CD19 CAR T cells GC007g for ...
CD19-targeted CAR T cell therapy has shown promising results in which the complete remission (CR) rates as high as 70%–90% in treating relapsed ...
8.
ashpublications.org
ashpublications.org/blood/article/127/26/3312/35352/CD19-targeted-CAR-T-cell-therapeutics-forCD19-targeted CAR T-cell therapeutics for hematologic ...
We review clinical results reflecting the investigational use of CD19-targeted CAR T-cell therapeutics in patients with B-cell hematologic malignancies.
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.