CAR T Cell Therapy for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with B-cell acute lymphoblastic leukemia, a type of blood cancer. The treatment modifies a person's immune cells in a lab to better target and attack cancer cells. Known as CAR T cell therapy, this approach uses Autologous Anti-CD19 CAR-expressing T Lymphocytes. The study aims to determine the safest dose and understand any side effects. It suits those aged 55 and older who have this specific leukemia and are currently in remission. Participants must have completed previous cancer treatments and have no immediate plans for a transplant.
As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using systemic steroids or chronic immunosuppressants. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that autologous anti-CD19 CAR T-cell therapy has been studied for safety and effectiveness. In earlier studies, these specially modified T cells showed promise in treating certain types of leukemia. Most patients handled the treatment well, though some experienced side effects.
Reports from past studies indicate that while some patients experience mild to moderate side effects, serious ones are less common. These side effects can include fever, tiredness, and low blood cell counts. The treatment works by modifying a patient's own T cells to better fight cancer, which can cause these reactions.
Since this trial is in the early stages, the main goal is to ensure the treatment's safety and determine the right dose. Safety evidence from previous studies, although limited, seems promising, especially since CAR T-cell therapies are already used for similar conditions.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for acute lymphoblastic leukemia, which often involve chemotherapy and radiation, CAR T Cell Therapy uses genetically engineered T cells to specifically target and destroy cancer cells. This treatment is unique because it involves reprogramming a patient's own immune cells to recognize and attack cells expressing the CD19 protein, commonly found on leukemia cells. Researchers are excited about this approach because it offers a targeted attack on cancer cells, potentially leading to fewer side effects and improved outcomes compared to traditional therapies. Plus, this therapy represents a personalized medicine approach, tailoring treatment to each individual's unique biology.
What evidence suggests that this treatment might be an effective treatment for acute lymphoblastic leukemia?
Research shows that autologous anti-CD19 CAR T-cell therapy, which participants in this trial will receive, could be promising for treating B-cell acute lymphoblastic leukemia. Studies have found that 70% to 90% of patients with relapsed leukemia achieved complete remission after receiving this therapy. Lab-created CAR T cells specifically target and destroy cancer cells, offering a personalized approach to fighting the disease. While this treatment has been effective, ongoing research aims to improve outcomes and manage potential side effects. Overall, this therapy represents a significant advancement in leukemia treatment.36789
Who Is on the Research Team?
Ibrahim Aldoss, MD
Principal Investigator
City of Hope Medical Cancer Center
Are You a Good Fit for This Trial?
Adults aged 55 or older with B-cell acute lymphoblastic leukemia in first remission can join this trial. They must have a good performance status, proper liver and kidney function, and no severe infections like HIV or hepatitis. Women of childbearing age need a negative pregnancy test and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and Pre-treatment
Patients undergo T cell leukapheresis and receive fludarabine and cyclophosphamide intravenously
Treatment
Patients receive CD19-CAR T cell infusion intravenously
Follow-up
Participants are monitored for safety, effectiveness, and adverse events after treatment
Long-term Follow-up
Participants are monitored for event-free survival, overall survival, and relapse
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Anti-CD19 CAR-expressing T Lymphocytes
Autologous Anti-CD19 CAR-expressing T Lymphocytes is already approved in United States, European Union for the following indications:
- B-cell acute lymphoblastic leukemia (ALL)
- Large B-cell lymphoma (LBCL)
- B-cell acute lymphoblastic leukemia (ALL)
- Diffuse large B-cell lymphoma (DLBCL)
- Large B-cell lymphoma (LBCL)
- Follicular lymphoma (FL)
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma (FL)
- Large B-cell lymphoma (LBCL)
- Follicular lymphoma (FL)
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma (FL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator