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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06947460
- Acronym / sponsor ID
- BJGBYY-IIT-LCYJ-2025-024
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19-BCMA CART therapy. | Experimental | Drug: CD19-BCMA CAR-T cells infusionPatients were treated with CD19-BCMA CART |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (52 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- Complicated with other types of malignant tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19-BCMA CAR-T cells infusionApproximately 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. | Drug | CD19-BCMA CART therapy. |
Primary outcome
Phase I (Dose-Escalation/Dose-De-escalation Phase)
Time frame: 28 days；30 days
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
Phase II (Dose-Expansion Phase)
Time frame: 90,180 Days
Overall remission rate (ORR)
2 secondary outcomes
Phase I (Dose-Escalation/Dose-De-escalation Phase)
Time frame: 90,180 Days； From 30 Days to 2 Years Post-CD19-BCMA CAR-T Infusion
Phase II (Dose-Expansion Phase)
Time frame: Up to 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZHOU (86+18511772961, zhousn@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I (Dose-Escalation/Dose-De-escalation Phase) (time frame: 28 days；30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.