The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory POMES Syndrome.
Primary Objectives 1\. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with relapsed and refractory POMES Syndrome. Secondary Objectives 1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with POMES Syndrome. 2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
30mg/m2/d
300mg/m2/d
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 6 months
Overall complete remission rate defined by the standard response criteria for POMES Syndrome
Overall complete remission rate defined by the standard response criteria for POMES Syndrome
Time frame: 8 weeks
Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Time frame: 6 months
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