Interleukin-2 Following 4SCAR19/22 T Cells Targeting Refractory and/or Recurrent B Cell Malignancies
Status:
Suspended
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Clinical studies of CD19 CAR-T cells in the treatment of blood and lymphatic system tumors
have achieved unprecedented successes. Because of the heterogeneity of the tumor, patients
often carry CD19-negative tumor cell clones that express alternative target antigens (such as
CD22, CD20 and CD123). In order to effectively eradicate all tumor clones and prevent
recurrence, alternative tumor antigens besides CD19 are considered for CAR-T cell targeting.
In this tudy, autologous T cells are genetically modified with 4th generation anti-CD19 and
anti-CD22 CARs (4SCAR19/22) using lentiviral vectors. For safety consideration, the 4SCAR is
engineered with an inducible caspase 9 self-withdrawal genetic design that allows for rapid
elimination of the infused CAR-T cells. Interleukin-2 has been shown to boost immune response
against leukemia cells. The serum interleukin-6 level will be monitored and when it returns
to normal range by day 28 after CAR-T cell infusion, patients will receive subcutaneous
injection of interleukin-2, and evaluated for 24 months for safety, efficacy and persistence
of CAR T cells.