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KN5501 Cell Injection for Refractory SLE(CLEAR)

ConditionSystemic Lupus Erthematosus (SLE)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRuitherapeutics Co., LTD

About this trial

The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE). It will also learn if KN5501 cell injection works to treat refractory SLE. The main questions it aims to answer are:

1. Is KN5501 cell injection safe in adults with SLE? And the maximum tolerated dose? 2. Does KN5501 cell injection lower the disease activity of SLE in adults with refractory SLE？

Participants will:

Receive one or multiple (3 to 5 times) intravenous infusion of KN5501 cell injection at inpatient ward after lymphodepletion.

Visit the clinic at predefined frequency (from 1 week interval to 12-16 weeks' interval) for checkups and tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Aged 18~70(including thresholds) when obtaining informed consent;

2. Body weight > 40.0 kg at screening;

3. Refractory SLE patients with moderate to severe activity;

4. CBC meeting predefined requirements at screening, including ANC ≥ 1.5×10^9/L, Hb ≥ 80g/L, and PLT ≥ 50×10^9/L(Not applicable, if it is ITP due to active SLE disease which is judged by investigator);

Disqualifiers

1. Hypersensitive or allergic to any components of KN5501(e.g. DEXTRAN 40) or other trial interventions including fludarabine, cyclophosphamide, and tocilizumab, or having ever experienced severe anaphylaxis;

2. Severe lupus nephritis patients, defined as proteinuria ≥3.5g/24h or a history of renal replacement therapy. Or high risk of progressive LN disease which will probably require induced intensive treatment;

3. CNS affected, including but not limited to lupus encephalopathy, seizure, strock(ischemic or hemorrhagic), dementia, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or mental disease;

4. Severe lung disease, e.g. pulmonary hypertension ≥ grade 3(WHO), or requiring mask oxygen therapy or ventilator-assisted breathing(non-invasive or invasive) ;

Trial design

Design model

Sequential

Treatments tested in this trial

  • KN5501 cell injection

    Drug

    In Part 1(SAD), six different doses will be explored to establish maximum tolerated dose for single-dose setting; In part 2(MAD and expansion), about 2-4 multiple-dose dosing regimen will be explored, and cohorts of 1-2 dosing regimen will be selected to expand.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: KN5501 cell injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity

Time frame
from the first dose to 2 weeks (SAD) or 4 weeks (MAD)
2

Number of participants with adverse events

Number of participants with adverse events(including abnormal physical examinations(PE), abnormal vital signs, abnormal laboratory test results and abnormal 12-ECG readings

Time frame
from enrollment to the last assessment at 52 weeks

Secondary outcomes

1

Time to Peak Plasma Concentration (Tmax)

Time frame
from the first dose to 4 weeks.
2

Peak Plasma Concentration (Cmax)

Time frame
from the first dose to 4 weeks
3

Area under the plasma concentration versus time curve (AUC)

Time frame
from the first dose to 4 weeks.
4

Duration of retention

Time frame
from the first dose to 4 weeks

Other outcomes

Sponsors and contacts

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

Ruitherapeutics Co., LTD

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: