CD33 CAR-NK Cells for AML
(CD33 CAR NK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for acute myeloid leukemia (AML) that has either returned or not responded to other treatments. The treatment uses specially modified immune cells from a healthy donor, known as CD33 CAR-NK cells, to target and destroy cancer cells. The trial will first determine the safest dose and then evaluate its effectiveness. People with AML that hasn't responded to two rounds of chemotherapy or has returned after treatment might be suitable candidates. Participants will be closely monitored in the hospital and may need to undergo additional procedures to track their progress. As a Phase 1 trial, the 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 for the trial?
The trial requires that you stop certain medications before starting. Specifically, you cannot have had AML-directed therapies in the 14 days before the trial, except for hydroxyurea. You also need to be off systemic immunosuppressive therapy for at least 14 days before enrolling.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that CD33 CAR-NK cells show early signs of safety for treating acute myeloid leukemia (AML) that has returned or is unresponsive to other treatments. These specially modified immune cells from a healthy donor can be safely used in patients.
In earlier trials, patients generally tolerated CD33 CAR-NK cells well. Some side effects occurred, but they were usually manageable. The trials mainly involved patients whose AML had returned or did not respond to other treatments.
These studies suggest that this therapy is feasible and has a promising safety record. However, like any new treatment, more research is needed to fully understand its long-term safety.12345Why do researchers think this study treatment might be promising for AML?
Unlike the standard treatments for acute myeloid leukemia (AML), which often include chemotherapy drugs like cytarabine and anthracyclines, CD33 CAR-NK cells offer a novel approach by harnessing the power of engineered natural killer (NK) cells. These cells are specially designed to target and destroy leukemia cells by focusing on the CD33 protein found on their surface. This targeted action not only promises a more precise attack on cancer cells but also aims to reduce the collateral damage to healthy cells, potentially leading to fewer side effects. Researchers are excited about this treatment because it combines the specificity of CAR technology with the innate cancer-fighting abilities of NK cells, potentially offering a more effective and safer option for AML patients.
What evidence suggests that CD33 CAR-NK cells might be an effective treatment for AML?
Research has shown that CD33 CAR-NK cells, which participants in this trial will receive, could be promising in treating acute myeloid leukemia (AML). These specially modified immune cells are designed to find and destroy leukemia cells. Early results suggest they can be both effective and safe for patients with CD33-positive leukemia. Studies have demonstrated that these cells can attack cancer cells while causing less harm to healthy cells. Some research indicates that using CRISPR technology can enhance these cells' effectiveness, offering a potential breakthrough in AML treatment. Overall, the evidence supports the potential of CD33 CAR-NK cells to improve outcomes for patients with this type of leukemia.14567
Who Is on the Research Team?
Margaret Lamb, MD
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
This trial is for people with acute myeloid leukemia (AML) that hasn't improved or has returned after other treatments. Participants must be healthy enough to undergo chemotherapy and cell infusion, and willing to stay in the hospital for monitoring until their blood counts recover.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Participants receive lymphodepleting chemotherapy with Fludarabine and Cytarabine, along with oral Venetoclax
CD33 CAR NK Cell Infusion
Participants receive CD33 CAR NK cell infusion on day 7, and possibly a second infusion on day 14 for dose level 4
Follow-up
Participants are monitored for safety and effectiveness after treatment, including bone marrow biopsy and potential lumbar puncture or imaging
Long-term Follow-up
Participants are monitored for potential long-term side effects of the cell therapy
What Are the Treatments Tested in This Trial?
Interventions
- Universal donor derived CD33 CAR-NK
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor