CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age10-65
SponsorBeijing GoBroad Hospital

About this trial

This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.

Eligibility criteria

Qualifiers

Refractory Lupus Nephritis(LN): Patients who meet all the following requirements can be enrolled in the group.

Male or female, aged 10-65 years;

Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);

The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and/or according to the detection results from center laboratory, during the screening visit,the anti dsDNA serum antibody test is positive (based on ELISA assay, ≥30 IU/mL);

Disqualifiers

Intracranial hypertension or disorder of consciousness;

Symptomatic heart failure or severe arrhythmia;

Symptoms of severe respiratory failure;

Complicated with other types of malignant tumors;

Trial design

Treatments tested in this trial

  • CD19-BCMA CAR-T cells infusion

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators