Study of KQ-2002 CD19CD22 CAR-T Cells for Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkins Lymphoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of anti-CD19CD22 CAR T cells called KQ-2002 in adults with relapsed or refractory CD19-positive B cell acute lymphoblastic leukemia ALL or non-Hodgkin lymphoma NHL. This early-phase study aims to understand how these engineered immune cells work in patients who have not responded to previous treatments or have relapsed. Participants will first undergo screening and leukapheresis to collect cells. They will then receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide over three days to prepare their body for the CAR T cell infusion. The KQ-2002 CAR T cells are infused between two to seven days after chemotherapy ends. The study includes dose escalation and dose expansion phases, testing different cell doses to determine safety and best dosing. During the study, participants will be closely monitored through physical exams, laboratory tests, and assessments for side effects. They will be followed for two years after the CAR T cell infusion to evaluate treatment responses and safety, with extended monitoring for up to 15 years to check for long-term effects. The main outcomes include the incidence of serious toxicities within 28 days and adverse events over the long term.

CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL