Refractory Lupus NephritisPhase 1/2NCT06947460
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
A Phase 1/2 study testing CD19-BCMA CAR-T cells infusion in people with Refractory Lupus Nephritis and Systemic Sclerosis, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension
- What is being tested?
- CD19-BCMA CAR-T cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2025to 31 Jul 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. 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;
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- 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.
- 2.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);
- Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;
- Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;
- Previously received other CAR-T therapies except CD19-CART.
- 3.pSS-PAH
- PH caused by other reasons: Portal hypertension, hereditary hemorrhagic telangiectasia, etc.; congenital heart disease; suspected drugs and toxicants; pulmonary hypertension related to chronic hypoxic diseases: moderate or severe obstructive pulmonary disease: FEV1 < 55%; moderate or severe restrictive pulmonary disease: TLC < 60%; pulmonary hypertension due to chronic thromboembolic disease: pulmonary ventilation/perfusion imaging suggests moderate or high suspicion of pulmonary thromboembolism;
- 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).
- Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;
- Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;
- Previously received other CAR-T therapies except CD19-CART.
- 6) Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab; 7) Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening; 8) Previously received other CAR-T therapies except CD19-CART. 4. AID
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
北京高博医院
Beijing, China,Beijing, 102200
周胜男, 18511772961, zhousn@gobroadhealthcare.com
About this study
Official title: CD19-BCMA CART Cell Therapy for Refractory Systemic Lupus Erythematosus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren Syndrome Combined With Pulmonary Artery Hypertension (pSS-PAH): a Single-center, Open, Non-randomized, Single-arm Clinical Study
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]
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
- Being tested
- CD19-BCMA CAR-T cells infusion
- Medical subject headings
- Lupus Nephritis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-BCMA CAR-T cells infusionDrug
Approximately 3-5 days prior to CD19-BCMA CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CD19-BCMA CART therapy. | Experimental | Patients were treated with CD19-BCMA CART Receives: Drug: CD19-BCMA CAR-T cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I (Dose-Escalation/Dose-De-escalation Phase)
Dose-limiting toxicity (DLT) [Time Frame: 28 days] Incidence and type of dose-limiting toxicity(DLT) within 28 days of CD19-BCMA CAR-T infusion.
Adverse events (AEs) [Time Frame: 30 days] Total number, incidence and severity of adverse events (AEs) within 30 days of CD19-BCMA CAR-T infusion
Measured: 28 days；30 days
Phase II (Dose-Expansion Phase)
Overall remission rate (ORR)
Measured: 90,180 Days
Secondary outcomes (2)
Phase I (Dose-Escalation/Dose-De-escalation Phase)
Overall remission rate (ORR) [Time Frame: 90,180 Days]: The assessment of ORR by dose group at 90 and 180 days after CD19-BCMA CAR-T infusion (per disease-specific criteria: SLE-LN SRI-4/LLDAS/DORIS; SSc EUSTAR AI; pSS-PAH ESSDAI + PAH response per ESC/ERS 2022).
CAR T-Cell Pharmacokinetics [Time Frame: Up to 2 Years] Incidence and Grading of SAEs From 30 Days to 2 Years Post-CD19-BCMA CAR-T Infusion
Measured: 90,180 Days； From 30 Days to 2 Years Post-CD19-BCMA CAR-T Infusion
Phase II (Dose-Expansion Phase)
Incidence and Grading of AEs； CAR T-Cell Pharmacokinetics； Overall survival (OS), duration of response (DOR)
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start18 Apr 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947460
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2025-024
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided