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A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)

Sponsored by Shanghai GeneChem Co., Ltd.

About this trial

Last updated 8 years ago

Study ID

CD19-CART for SLE

Status

Unknown status

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 69 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Clinical diagnosis of systemic lupus erythematosus (SLE) patients

- Patients with CD19+ B-cell SLE as confirmed by Flow Cytometry

- Age: 18-69 years old

- Creatinine < 1.5 mg/dl

- cardiac ejection fraction>55%

- hemoglobin>9g/dL

- Bilirubin <2.0 mg/dl

- Successful test expansion of T-cells

- Adequate venous access for apheresis, and no other contraindications for leukapheresis

- Voluntary informed consent is given

No

Exclusion Criteria

- Pregnant or lactating women

- Uncontrolled active infection

- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary

- Previously treatment with any gene therapy products

- Feasibility assessment during screening demonstrates<5% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation

- Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, serious arrhythmia)

Locations

Location

Status

Recruiting