Phase 12 Study of Dual-Target CD19CD22 CAR T-Cell Therapy in Children and Young Adults With Recurrent or Resistant B-Cell Leukemia and Lymphoma

What this Trial Is About

Acute lymphoblastic leukemia ALL is the most common cancer in children, with high cure rates for initial treatment but much lower survival if the disease returns. This trial studies a new type of CAR T-cell therapy targeting two proteins, CD19 and CD22, on cancer cells in children and young adults with recurrent or refractory B-cell leukemia or lymphoma. The study aims to improve treatment by addressing challenges seen with previous single-target CAR therapies and is conducted in phase 1 and 2 stages to assess safety and effectiveness. Participants will have their own T cells collected and genetically modified to target both CD19 and CD22. Before receiving the CAR T-cell infusion, participants undergo chemotherapy conditioning with cyclophosphamide and fludarabine, with two possible dosing regimens based on individual factors. The modified T cells are then infused back into the participants body. The study includes dose escalation and expansion cohorts based on disease burden and antigen expression, with participants grouped accordingly for treatment. During the study, participants undergo comprehensive screening including physical exams, blood and urine tests, heart and lung function tests, imaging, bone marrow biopsy, and lumbar puncture. After treatment, participants are monitored closely with clinic visits twice weekly for 28 days, followed by long-term follow-up lasting up to 15 years to assess safety, tumor response, CAR T-cell persistence, and overall outcomes. Researchers collect data on safety, efficacy, and biological effects throughout this period.

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies