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IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)

ConditionRefractory Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University Third Hospital

About this trial

The study is a single-arm, open-label clinical trial intended to recruit 6 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10\^6/kg or 1×10\^8 CAR-T cells . The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) at 90 days and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the long-term efficacy was evaluated, including the improvement of SLEDAI-2K score and achieving lupus low disease activity (LLDAS) at day 180 and day 360, and renal response at day 180 and day 360. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1)The subject was diagnosed with systemic lupus erythematosus and met the classification criteria of EULAR/ACR 2019 SLE (see Annex 2)

2) Age ≥ 18 years old, ≤ 65 years old

3) Weight ≥ 40 kg

4) Meets the current clinical standards for refractory systemic lupus erythematosus: the disease remains active or relapses and progresses after systemic treatment using the current standard treatment regimen, including steroids (sufficient or shock therapy), immunosuppressants (cyclophosphamide or mycophenolate mofetil), and biologics (belizumab or Rituximab)

Disqualifiers

1) After evaluation by researchers, it is determined that the subject has diseases that are not suitable for participation in this study, such as life-threatening conditions (e.g., catastrophic antiphospholipid syndrome, acute severe renal failure, acute severe central nervous system disease manifestations).

2) The research subject has a history of alcohol or drug abuse within the past 24 weeks.

3) The research subject has a history of malignant tumors other than B-cell lymphoma.

4) Major surgery (including joint surgery) was performed within 24 weeks prior to screening, or surgery is planned within 24 weeks after enrollment in the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • IM19 CAR-T cells

    Biological/Vaccine

    IM19 CAR-T cells by intravenous infusion.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: CAR-T cell therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline of SLEDAI-2K score at 90 days after IM19 CAR T cell transfusion.

Change from baseline of SLEDAI-2K score at 90 days after IM19 CAR T cell transfusion. Range \[0,105\], higher values indicate worse disease activity.

Time frame
90 days
2

Adverse events related to IM19 CAR-T cell therapy within 28 post-infusion.

The occurrence of adverse events related to IM19 CAR-T cell therapy within 28 post-infusion.

Time frame
90 days

Secondary outcomes

1

Change from baseline of SLEDAI-2K score at day 180 and day 360 after IM19 CAR T cell transfusion.

Change from baseline of SLEDAI-2K score at day 180 and day 360 after IM19 CAR T cell transfusion. Range \[0,105\], higher values indicate worse disease activity.

Time frame
180 days and 360 days
2

Achieving low disease activity status (LLDAS) at day 180 and day 360 post IM19 CAR-T cell infusion.

Achieving low disease activity status (LLDAS) at day 180 and day 360 post IM19 CAR-T cell infusion.

Time frame
180 and 360 days
3

Renal response at day 180 and day 360 post CAR-T cells infusion.

Complete renal response was defined as 24-hour urine protein ≤0.5 g/day; partial renal response was defined as proteinuria ≥50% reduction from baseline and 24-hour proteinuria \<3.5 g/day or protein-creatinine ratio (PCR) \<3.0mg/g, with stable or improved kidney function (±10%-15% of baseline).

Time frame
180 and 360 days.
4

The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects.

The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects.

Time frame
360 days

Other outcomes

Sponsors and contacts

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

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov
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