Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd
About this trial
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.
Eligibility criteria
Qualifiers
The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
Age ≥ 18 years old , gender not limited;
Patients diagnosed with SLE according to the 2019 EULAR/ACR classification criteria,And by hydroxychloroquine, sufficient glucocorticoid (≥1mg/kg/d prednisone or equivalent amount of other hormones), to less than 2Treatment with immunosuppressants (including cyclophosphamide, motecophanate, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, etc.), and at least one approved biological agent (including titacept, Beliuzumab, etc.), with a total duration of treatment ≥3 months, still in a disease active state, or unable to tolerate conventional therapy;
SLEDAI-2K score ≥7 points;
Disqualifiers
There were severe active central nervous system lupus that required therapeutic intervention at the time of screening;
Acute severe nephritis: had or was undergoing renal replacement therapy within 3 months prior to reinfusion, or had significant renal deterioration that the investigator believed was likely to cause the subject to require high doses of corticosteroids (prednisone ≥1mg/kg/ day or equivalent of other hormones), cyclophosphamide, or mycophanate during the first 3 months of the study;Clinical stable lupus nephritis that can be controlled during screening can be considered;
There were other lupus crises that were not controlled at the time of screening;
Individuals who have received CAR-T therapy or other gene modified cell therapies;
Trial design
Treatments tested in this trial
- MC-1-50
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Chongqing Precision Biotech Co., Ltd
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Source ClinicalTrials.gov