Health TrialsbyHealthPanel

Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd

About this trial

This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old;

Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod), and/or hydroxychloroquine, and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, beliumab, and rituximab) or intolerant to standard treatments;

SLEDAI-2K score ≥ 8 points;

Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;

Disqualifiers

Central nervous system (CNS) disease: CNS neurolupus requires intervention within 30 days;

Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or NYHA classification class IV; or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patient with unstable vital signs who need hypertensive drugs;

The functions of important organs meet one of the following conditions: (1)renal function: eGFR<30mL/min/1.73m2 or require renal replacement therapy; (2)liver function: AST and ALT>3.0 ULN, total Bilirubin (TBIL) in serum >2.0×ULN; (3)lung function: SpO2<92% with no oxygen inhalation;

Uncontrollable infection or active infection that requires systemic treatment within 3 months prior to screening;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19 CAR-T cells

    Biological/Vaccine

    Three dose groups (1.5×10\^5/kg, 5×10\^5/kg, 10×10\^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: CAR-T treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The safety of CAR-T cell therapy in patients with refractory SLE [Safety]

Types, frequency and severity of adverse events.

Time frame
3 months
2

The changes from baseline in SLEDAI-2K [efficacy]

Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K) is from 0 to 105 points. The higher score means the stronger disease activity.

Time frame
6 months
3

The changes from baseline in PGA [efficacy]

Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scales. "0" indicates no disease activity and "3" indicates the most severe disease activity.

Time frame
6 months
4

The changes from baseline in BILAG-2004 [efficacy]

British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is classified as A, B, C and D respectively. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is not involved.

Time frame
6 months

Secondary outcomes

1

The changes of anti-ds-DNA antibody after infusion [efficacy]

Time frame
6 months
2

The changes of 24h urine protein after infusion [efficacy]

Time frame
6 months
3

The changes of serum complement C3 and C4 after infusion [efficacy]

Time frame
6 months
4

Cmax of CAR-T cells [PK parameter]

The peak plasma concentration (Cmax) of amplified CAR-T cells in peripheral blood after infusion.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing Precision Biotech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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