Health TrialsbyHealthPanel

CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus

ConditionRefractory Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age16-55
SponsorVinmec Research Institute of Stem Cell and Gene Technology

About this trial

The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have demonstrated inadequate response to standard-of-care immunosuppressive treatments.

The primary questions this study aims to address are:

What is the incidence, nature, and severity of treatment-emergent adverse events following CD19 CAR-T cell infusion? Is administration of CD19 CAR-T cell therapy feasible and tolerable in patients with refractory systemic lupus erythematosus? This study is conducted as a single-arm trial without a comparison group.

Participants will:

Undergo leukapheresis for collection of autologous peripheral blood mononuclear cells Receive a protocol-defined lymphodepleting chemotherapy regimen prior to CAR-T cell infusion Receive a single intravenous infusion of approximately 1.0 × 10⁶ CD19 CAR-T cells per kilogram of body weight Undergo scheduled clinical evaluations, laboratory testing, and longitudinal follow-up to assess safety, tolerability, and clinical parameters

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 16 to 55 years, male or female

Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria with a total score ≥ 10

SLEDAI-2K score ≥ 8 at screening (with at least 4 points derived from laboratory parameters; excluding points attributable to central nervous system involvement)

Positive antinuclear antibody (ANA ≥ 1:80) OR positive anti-dsDNA OR positive anti-Sm antibody at screening or documented in medical history

Disqualifiers

History of significant neurologic disorders (e.g., traumatic brain injury, seizure disorder, hemorrhagic conditions, impaired consciousness)

Significant cardiovascular disease within 3 months prior to screening (e.g., uncontrolled hypertension, NYHA Class III-IV heart failure, severe arrhythmia, unstable angina, myocardial infarction)

Prior kidney transplantation

Severe asthma requiring long-term treatment or respiratory failure

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous CD19-Targeted CAR-T Cells

    Biological/Vaccine

    Autologous chimeric antigen receptor T cells targeting CD19, manufactured from participants' peripheral blood T cells collected by leukapheresis. Cells are genetically modified ex vivo to express a CD19-specific CAR, expanded, and administered as a single intravenous infusion following protocol-defined lymphodepleting chemotherapy. Participants undergo post-infusion monitoring for safety and immunological effects according to the study protocol.

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: CD19 CAR-T Cell TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of Frequency and Severity of Adverse Events and Serious Adverse Events

Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to ASTCT criteria.

Time frame
From CAR-T cell infusion through Day 360

Secondary outcomes

1

Proportion of Participants Achieving Remission According to DORIS Criteria

Proportion of participants achieving complete or partial remission according to the Definitions of Remission in SLE (DORIS) criteria.

Time frame
Day 90 and Day 360
2

Proportion of Participants Achieving Lupus Low Disease Activity State (LLDAS)

Proportion of participants meeting Lupus Low Disease Activity State (LLDAS) criteria.

Time frame
Day 90 and Day 360
3

Proportion of Participants Experiencing Disease Relapse

Proportion of participants with disease relapse after achieving clinical response.

Time frame
From Day 90 through Day 360
4

Manufacturing Success Rate of Autologous CD19 CAR-T Cells

Proportion of enrolled participants for whom autologous CD19 CAR-T cells are successfully manufactured and released for administration

Time frame
From leukapheresis through product release, up to 12 days

Other outcomes

Sponsors and contacts

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

Vinmec Research Institute of Stem Cell and Gene Technology

Lead sponsor

Source ClinicalTrials.gov
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