CAR T Cell Therapy for Childhood Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a new treatment called CD19-CD22-CAR T cell therapy, a type of immunotherapy, for children and young adults with acute lymphoblastic leukemia, a challenging blood cancer. The research examines how effectively this treatment targets and attacks cancer cells. It is suitable for individuals under 21 whose leukemia has not improved with other treatments or has returned after a transplant. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I need to stop my current medications for the trial?
The trial information does not specify if 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 treatment is likely to be safe for humans?
Research has shown that CD19-CD22 CAR T cell therapy has generally been well-tolerated in early studies. This treatment uses specially modified immune cells to target and destroy cancer cells. In past studies, most patients experienced manageable side effects. Common issues included fever and low blood cell counts, typical for this kind of treatment. Some patients faced more serious side effects, though these were less common.
As this is a phase 1 trial, the main goal is to assess the treatment's safety and determine the appropriate dose. The treatment is still undergoing careful testing for safety in humans. Prospective participants should know that while early results are promising, the complete safety profile is still under investigation.12345Why are researchers excited about this study treatment for leukemia?
Researchers are excited about CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for childhood acute lymphoblastic leukemia because it offers a unique approach compared to standard treatments like chemotherapy and radiation. Unlike these traditional options, this CAR T cell therapy is engineered to specifically recognize and attack cancer cells by targeting two proteins, CD19 and CD22, on the leukemia cells. This dual targeting mechanism increases the precision and effectiveness of the treatment, potentially leading to better outcomes. Additionally, the personalized nature of CAR T cell therapy, which involves engineering a patient's own immune cells, could reduce the risk of relapse and improve long-term survival rates.
What evidence suggests that CD19-CD22-CAR T cell therapy might be an effective treatment for childhood acute lymphoblastic leukemia?
Research has shown that a new treatment, CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T cell therapy, may help treat a challenging type of blood cancer called B-cell acute lymphoblastic leukemia (ALL). Participants in this trial will receive this therapy. Some studies found a reduction in cancer cells, although targeting CD22 was sometimes less effective. CAR T cells targeting CD19 have already improved outcomes for many patients with recurring B-cell ALL. By targeting both CD19 and CD22, this therapy aims to be more effective by attacking cancer cells with either of these proteins. Early results suggest that this combined approach might work better than targeting CD19 or CD22 alone.23678
Who Is on the Research Team?
Rebecca Epperly, MD
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for pediatric patients (≤ 21 years old) with recurrent or refractory leukemia that tests positive for CD19 and/or CD22. It's not suitable for those who don't meet the specific health criteria set by the researchers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Collection and Manufacturing
Patients will have white blood cells collected through apheresis or use a previously collected frozen product. The cells will be engineered to become CD19-CD22 CAR T cells.
Treatment
Eligible patients will receive lymphodepleting chemotherapy followed by CD19-CD22 CAR T cell infusion.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the incidence of adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor