A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)
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)
1 other identifier
interventional
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedFebruary 7, 2017
January 1, 2017
10 months
January 22, 2017
February 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of CAR-T cell（i.v.）by number of patients with adverse event
adverse event is evaluated with CTCAE, version 4.0
6 weeks
Secondary Outcomes (2)
Number of patients with tumor response
8 weeks
3. Detection of transferred T cells in the circulation using quantitative -PCR
6 weeks
Study Arms (2)
Reduce B cells
EXPERIMENTALPatients receive cyclophosphamide to reduce B cells before CD19-CART infusion. It will also reduce the side effects of cell damage due to antitumor activity.
Treatment of SLE
EXPERIMENTALPatients receive anti-CD19-CAR-T cells to treatment of SLE. The purpose of this study is to assess the safety and efficacy of CD19 CAR-T cells in the treatment of SLE.
Interventions
Patients receive cyclophosphamide (Cy) on day -2 and day -1 to reduce B cells. The dose is 0.5g/m2/d.
A 2nd CAR, CD19 as target protein, 4-1BB as co-stimulator, and optimized the spatial conformation by a suitable hinge \& transmembrane domain sequences. Patients infused with anti-CD19-CAR-T cells transduced with lentivirus on day 0 in the absence of disease progression or unacceptable toxicity to treatment of SLE. The dose is 1E6\~1E7 CD19-CAR positive T cells. The cells infusion process may last for 30 min.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating women
- Uncontrolled active infection
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai GeneChem Co., Ltd.lead
- RenJi Hospitalcollaborator
Study Sites (1)
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiang Guo, Doctor
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2017
First Posted
January 25, 2017
Study Start
March 1, 2017
Primary Completion
January 1, 2018
Study Completion
March 1, 2018
Last Updated
February 7, 2017
Record last verified: 2017-01