A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovatim Immune Therapeutics (Zhejiang) Co., Ltd.

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

Treatment groups

21 Participants
are divided into 4 treatment groups