Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE

ConditionsSystemic Lupus Erythematosus (SLE)Refractory

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

MC-1-50
Biological/Vaccine
A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: MC-1-50Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Dose-limiting toxicity after CD19 CAR-T cell infusion

Time frame

1 month

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

Time frame

1 month

Secondary outcomes

Validity endpoint of MC-1-50 cells [Efficacy]

3M SRI-4 response rate, 6M LLDAS, DORIS response rate，SLEDAI-2K score, PGA, and BILAG-2004 change from baseline

Time frame

3 months

AUCS of MC-1-50 cells [Cell dynamics]

AUCS is defined as the area under the curve in 28/90 days

Time frame

3 months

CMAX of MC-1-50 cell preparation [Cell dynamics]

CMAX is defined as the highest concentration of MC-1-50 cells expanded in peripheral blood

Time frame

3 months

TMAX of MC-1-50 cell preparation[Cell dynamics]

TMAX is defined as the time to reach the highest concentration

Time frame

3 months

Other outcomes

Response rate after MC-1-50 infusion [Long-term Efficacy]

The DORIS response rate, LLDAS maintenance rate, and SRI-4 response rate at the remaining sites after reinfusion when other drugs (including hormones, hydroxychloroquine, immunosuppressants, and biologics) were discontinued.And changes from baseline in SLEDAI-2K scores, PGA scores, BILAG-2004 scores, and serological indicators, including anti-DSDNA, anti-nuclear antibodies, and complement C3 and C4 levels

Time frame

2 years

The rebuilding of the immune system

Proportion of B-cell subtypes at each site and their association with reduced disease activity

Time frame

2 years