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Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;

Be over 18 years of age, male or female;

A diagnosis of SLE according to the 2012 systemic lupus international collaborating clinics(SLICC);

Conventional regimens for SLE are corticosteroids and one or more immunomodulatory drugs over 6 months;

Disqualifiers

Prior to screening, other lupus crises, such as active central nervous system lupus, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.

Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.

IgA deficiency was present during screening (serum IgA level < 10 mg/dL).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Metabolically Armed CD19 CAR-T cells

    Drug

    Each subject receive metabolically armed CD19 CAR- T cells by intravenous infusion

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Administration of Metabolically Armed CD19 CAR-T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MTD

Determine the Maximal Tolerable Dose(MTD).

Time frame
MTD will be determined based on Dose-limiting toxicity (DLTs) observed during the first 35 days of study treatment.
2

DLTs

Adverse events assessed according to NCI-CTCAE v5.0 criteria.

Time frame
Up to 35 days after META 10-19 infusion.
3

Incidence of treatment-emergent adverse events(TEAEs)

To characterize the safety of META10-19 for moderate to severe active SLE.

Time frame
Up to 12 months after META 10-19 infusion

Secondary outcomes

1

Proportion of subjects achieving DORIS remission

DORIS remission will be assessed based on the 2021 DORIS remission criteria.

Time frame
on Day 28, Month 3, and Month 6 following META 10-19 infusion.
2

Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS)

Time frame
on Day 28, Month 3, and Month 6 following META 10-19 infusion.
3

Proportion of subjects achieving SRI-4

SRI-4 (SLE Responder Index-4) response, assessed using SLEDAI-2000, BILAG, and PGA scores.

Time frame
on Day 28, Month 3, and Month 6 following META 10-19 infusion.
4

Concentration of CAR-T cells

Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion.

Time frame
Up to 12 months after CAR-T treatment.

Other outcomes

Sponsors and contacts

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

Zhejiang University

Lead sponsor

Leman Biotech Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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