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

Recruiting now · Phase 1/Phase 2

Conditions studied: Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)

In brief

This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) and other autoimmune diseases (AID) receive CD19-BCMA CAR T cell therapy. Phase I (Dose-Escalation/Dose-De-escalation Phase)：The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, pSS-PAH and other autoimmune diseases (AID).Phase I (Dose-Escalation/Dose-De-escalation Phase)：Primary Endpoint: Safety, tolerability, and determination of the optimal biological dose (OBD) and the Phase II recommended dose (RP2D) in patients with SLE-LN, SSc, pSS-PAH, and other autoimmune diseases (AID).Phase II (Dose-Expansion Phase):Overall remission rate (ORR) \[Time Frame: 90,180 Days\]

Key facts

Study ID: NCT06947460
Run by: Beijing GoBroad Hospital
People needed: 45
Starts: 2025-04-18
Expected to finish: 2026-07-31
Last updated by the study team: 2026-07-30

Who can join

Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

An individual who meets any of the following criteria will be excluded from participation in this study:
Refractory Lupus Nephritis (LN):
Intracranial hypertension or disorder of consciousness;
Symptomatic heart failure or severe arrhythmia;
Symptoms of severe respiratory failure;
Complicated with other types of malignant tumors;
Diffuse intravascular coagulation;
Suffering from septicemia or other uncontrollable infections;
Patients with uncontrollable diabetes and other endocrine diseases;
Severe mental disorders;
Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);
Have received organ transplantation (excluding bone marrow transplant);
Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;
Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;
The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;
eGFR CKD-EPI < 30 ml/min/1.73m\^2;
Any active skin disease that may interfere with the assessment of systemic lupus erythematosus (SLE) research, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous manifestations (e.g., cutaneous vasculopathy, perivascular telangiectasia, sclerodactyly, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus;
Previously received other CAR-T therapies except CD19-CART.
SSc
Other connective tissue disease: Rheumatoid Arthritis, System Lupus or Inflammatory Myopathies;
Clinical manifestations can be explained by disease similar to SSc: hand joint lesions related to nephrogenic systemic fibrosis, generalized morphea, eosinophilic fasciitis, diabetic scleredema, scleromyxedema, erythromelalgia, porphyria, lichen sclerosus, graft-versus-host disease, diabetes mellitus, and other endocrine and metabolic diseases;
Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;
Dialysis patients or Ccr <30ml/min;
Pregnant or suckling period;
Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis);

Where it is running

北京高博医院 — Beijing, China,Beijing, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.