About this trial
This is a multicenter, open-label, dose-escalation/expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and determine the recommended dose of KQ-2003 CAR T-cells for patients with Relapsed/Refractory POEMS Syndrome
Eligibility criteria
Qualifiers
Age ≥18 years old, male or female;
Diagnosis of POEMS syndrome with relapsed or refractory disease;
Eastern Cooperative Oncology Group (ECOG) Performance ≤2 ;
Adequate venous access for the apheresis of peripheral blood mononuclear cell;
Disqualifiers
Subjects who had previously received BCMA-CD19 dual-target CAR-T cell products or autologous stem cell transplantation within 12 weeks before the collection of peripheral blood mononuclear cells;
Known allergy or hypersensitivity reactions to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), CD19, or BCMA-targeted drugs;
Received any treatment that might influence the activity of CAR-T cells prior to the collection of peripheral blood mononuclear cells;
Have history of vaccination within the 4 weeks preceding the collection of peripheral blood mononuclear cells;
Trial design
Treatments tested in this trial
- KQ-2003 CAR T-cells