Acute lymphoblastic leukemia (ALL) accounts for over 75% of all childhood leukemia, the most common childhood cancer, with the majority of these being of the B-cell origin. Although chemotherapy and hematopoietic stem cell transplant (HSCT) may lead to long-term remission in the most patients, many will experience further relapses or residual disease that is resistant to various treatments. Patients who relapse after intensive upfront therapy often have chemo-resistant disease, with 5-year overall survival rates of only 36%. Additionally, with second and subsequent relapses, the responsiveness to chemotherapy declines further with very low rates of complete response (44% and 27% for tr 3rd and 4th treatment, respectively) and a long-term survival of less than 20%. Novel therapeutic agents are desperately needed to improve long-term survival in these groups of patients, and immunotherapies are emerging as effective treatment strategies in the relapsed and refractory setting. The Trivalent CAR T-cell therapy provides a therapeutic option after failure of CD19-targeting therapies where other curative options are lacking. CAR T-cell therapy is when a patient’s own T-cells (white blood cells that kill cancer cells) are collected via blood draw, then engineered to target specific cancer cells, multiplied, and infused back into the patient. This CAR T-cell therapy will have three targets: CD19, CD20, and CD22. This phase I study will evaluate the safety of the Trivalent CAR T-cell therapy in children and young adults with relapsed or refractory B-lineage leukemia. This is the first time a trivalent CAR T-cell product is used to fight a cancer in children, adolescents, and young adults.
Trial Registration: ClinicalTrials.gov Identifier: NCT05010564