Health TrialsbyHealthPanel

Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE

ConditionsCAR T Cell TherapySystemic Lupus ErythematosusBCMA
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age:≥5 years old;

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

SLEDAI 2K score≥8 points;

The functions of important organs are as follows: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML/min/1.73m2；Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN; Lung function: No serious lung lesions, SpO2≥92%;

Disqualifiers

Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);

Severe acute nephritis: Patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; Or in the investgator's opinion, patients who is likely to have significant kidney disease within 3 moths of the study which need high dose glucocorticoid (prednisone dose≥1mg/kg/day or equivalent amount of other steriod), cyclophosphamide, or MMF treatment;

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 combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs；

Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-BCMA/CD70-CAR-T cells

    Biological/Vaccine

    Three dose groups (0.3×105/kg, 1×105/kg, 3×105/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 BCMA/CD70 CAR-T cell therapy in patients with refractory SLE

Incidence and severity of AEs and SAEs,including changes in laboratory values, Electrocardiograph(ECG) and vital signs assessed by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame
3 months
2

The efficiency of CAR-T cell therapy in patients with refractory SLE

Number of patients with SRI-4 response:including SLEDAI-2K ≥ 4-Point improvement, PGA with no worsening (\&amp;amp;amp;lt;0.3-point increase), BILAG 2004 with no new A domain score and no more than 1 new B domain scores. Number of patients with DORIS: including SLEDAI-2K = 0 and a Physician's Global Assessment (PGA) \< 0.5, irrespective of serology, with permitted use of antimalarials, low-dose glucocorticoids (GCs; prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.

Time frame
6 months

Secondary outcomes

1

Cellular kinetics

CAR transgene levels by quantitative polymerase chain reaction (qPCR) in peripheral blood.

Time frame
6 months
2

Autoantibody detection

Autoantibody detection up after BCMA/CD70 CAR-T cells infusion.

Time frame
24 months
3

Pharmacokinetic Outcome AUC

The area under the curve (AUC) at 28 days and 90 days post-infusion (AUC28d/90d)

Time frame
3 months
4

Duration of disease response (DOR)

The time between the first investigator assessment of remission and the first investigator assessment of progression or death from any cause.

Time frame
24 months

Other outcomes

Sponsors and contacts

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

The Children's Hospital of Zhejiang University School of Medicine

Lead sponsor

Chongqing Precision Biotech Co., Ltd

Collaborator

Source ClinicalTrials.gov
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