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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 16 December 2017
Main ID:  NCT03030976
Date of registration: 22/01/2017
Prospective Registration: Yes
Primary sponsor: Shanghai GeneChem Co., Ltd.
Public title: A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)
Scientific title: 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)
Date of first enrolment: March 2017
Target sample size: 5
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Name:     Qiang Guo, Doctor
Telephone: 86-21-63835620
Name:     Qiang Guo, Doctor
Telephone: 86-21-63835620
Name:     Qiang Guo, Doctor
Affiliation:  RenJi Hospital
Key inclusion & exclusion criteria

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

Exclusion Criteria:

- Pregnant or lactating women

- Uncontrolled active infection

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

- 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)

Age minimum: 18 Years
Age maximum: 69 Years
Gender: All
Health Condition(s) or Problem(s) studied
Systemic Lupus Erythematosus (SLE)
Drug: anti-CD19-CAR-T cells
Drug: cyclophosphamide
Primary Outcome(s)
Safety of CAR-T cell(i.v.)by number of patients with adverse event [Time Frame: 6 weeks]
Secondary Outcome(s)
3. Detection of transferred T cells in the circulation using quantitative -PCR [Time Frame: 6 weeks]
Number of patients with tumor response [Time Frame: 8 weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
RenJi Hospital
Ethics review
Results available:
Date Posted:
Date Completed:
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