New Hope for Relapsed/Refractory AML: Groundbreaking CAR-NK Cell Therapy Enters Phase 1/2 Trials
A pioneering clinical trial is offering a beacon of hope for patients battling acute myeloid leukemia (AML) that has proven resistant to conventional treatments or has returned after initial therapy. The Phase 1/2 study is evaluating a novel approach utilizing genetically engineered immune cells, specifically CD33 CAR-NK cells, derived from healthy donors to target adn destroy cancer cells.
This innovative treatment strategy represents a significant advancement in the field of immunotherapy for AML. The trial is structured in two distinct phases. The initial Phase I component is meticulously designed to identify the optimal and safest dosage of the CD33 CAR-NK cell therapy. Following this, the Phase II portion will assess the efficacy of the treatment at the determined dose, measuring its effectiveness in combating the leukemia.
Participants in the study will first undergo a screening process. Later, thay will receive a regimen of chemotherapy, consisting of Fludarabine and Cytarabine in combination with Venetoclax, before being infused with the CD33 CAR-NK cells. Depending on the investigator’s assessment, some patients may receive two infusions of the CAR-NK cells, administered one week apart. the treatment protocol mandates hospitalization for both the chemotherapy and cell infusion to ensure close monitoring of patients.Hospitalization will continue until the patients’ blood counts recover. For those discharged before day 35, weekly clinic visits will be scheduled for blood work and physical examinations.
A crucial assessment of treatment response will involve a bone marrow biopsy conducted around day 28-35 to evaluate the patient’s remission status. Additional procedures, such as lumbar puncture or imaging, may be performed if deemed necessary by the study physician.
Patient follow-up is extensive, with ongoing monitoring for research purposes and clinical outcomes, including leukemia relapse and survival, for a period of one year. After this initial year, participants will have completed their formal study involvement but will continue to be monitored for up to 15 years to track any potential long-term side effects associated with the cell therapy.It is indeed also noted that some patients may proceed to a bone marrow transplant following the study treatment. for those undergoing a transplant, a single blood sample will be collected approximately one month post-transplant, after which their study participation will be concluded.
Last updated: Aug. 2, 2025
This trial marks a critical step forward in the fight against AML. What are your thoughts on the potential of CAR-NK cell therapy? Share your insights in the comments below,and don’t forget to subscribe to World Today News for more updates on cutting-edge medical advancements!
