Health TrialsbyHealthPanel

Study of CD19 CAR-T Therapy for Refractory SLE

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorChongqing Precision Biotech Co., Ltd

About this trial

This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 5 years, no gender limitation;

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

SLEDAI-2K score ≥ 8 points;

cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%, with no obvious abnormalities on electrocardiogram (ECG);

Disqualifiers

Central nervous system (CNS) diseases: presence of CNS lupus symptoms requiring intervention within 60 days, including epilepsy, confusion, cerebrovascular events, etc;

Congenital heart disease or severe arrhythmia before screening: Including multifocal and frequent supraventricular tachycardia, ventricular tachycardia, etc.; or complicated with moderate to large pericardial effusion, severe myocarditis, etc.; or patients with unstable vital signs who require vasopressors to maintain blood pressure;

Presence of active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening;

Having received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; or having grade 2 or above acute graft-versus-host disease (GVHD) within 2 weeks prior to screening;

Trial design

Design model

Single group

Treatments tested in this trial

  • PTOC1

    Biological/Vaccine

    Three dose groups (1.5×10\^5/kg, 5×10\^5/kg,1×10\^6/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: PTOC1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The safety of PTOC1 cell therapy in patients with refractory SLE [Safety]

Types, frequency and severity of adverse events.

Time frame
3 months
2

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

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

Time frame
6 months
3

The changes in PGA from baseline [efficacy]

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

Time frame
6 months
4

The changes in BILAG-2004 from baseline [efficacy]

British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is graded as A, B, C and D. "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 uninvolved.

Time frame
6 months

Secondary outcomes

1

Cmax of PTOC1 cells [PK parameter]

The peak concentration (Cmax) of amplified PTOC1 cells in peripheral blood after infusion can be measured.

Time frame
3 months
2

Tmax of PTOC1 cells [PK parameter]

The time for amplified PTOC1 cells in peripheral blood to reach the maximum concentration (Tmax) can be measured.

Time frame
3 months
3

AUC28d/90d of PTOC1 cells [PK parameter]

The area under the plasma concentration-time curve from 28 to 90 days after infusion (AUC28d/90d) can be measured.

Time frame
3 months
4

The degree of B cell depletion [PD parameter]

The degree of CD19+ B cell depletion at different time points.

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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