An Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With CD19+ B Cell Systemic Lupus Erythematosus (SLE)

NCT03030976 Phase 1 UNKNOWN

CAR-T therapy was therefore proposed and has been recently used for cancer treatment. It has been hailed for its promising remission rates after early stage clinical trials for acute lymphoblastic leukemia. However, CAR-T therapy is seldom used for autoimmune diseases. Researchers only use it for the treatment of multiple sclerosis (MS, an autoimmune disease of the central nervous system). SLE is a kind of autoimmune diseases which involving multiple systems, organs and with the present of a variety of autoantibodies. In the conventional treatment options, SLE could be treated with chemotherapy drugs or hormone drugs. But chemotherapy and hormone drugs could barely cured SLE. And now, chimeric antigen receptor modified T cell infusion maybe an effective treatment to solve these problems. The investigators use a 2nd CAR- T with the optimized hinge and transmembrane domain to treat patients with SLE. The purpose of this study is to assess the safety and efficacy of this 2nd CAR-T cells in the treatment of SLE.

Details

Lead sponsor	Shanghai GeneChem Co., Ltd.
Phase	Phase 1
Status	UNKNOWN
Enrolment	5
Start date	2017-03
Completion	2018-03

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

• cyclophosphamide
• anti-CD19-CAR-T cells

Primary outcomes

• Safety of CAR-T cell（i.v.）by number of patients with adverse event — 6 weeks
  adverse event is evaluated with CTCAE, version 4.0

Countries

China