Autoimmune DiseasesNCT07143617
Exploratory Clinical Study on the Safety of STR-P004
A study testing STR-P004 in people with Autoimmune Diseases, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
This is an open-label, multiple-dose escalation IIT clinical study aimed at evaluating the safety, tolerability, PK, and preliminary efficacy of STR-P004 in adult patients with relapsed or refractory autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- STR-P004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2025to 14 Sep 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the purpose, nature, method of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
- Aged ≥18 years (including the boundary value, based on the time of signing the informed consent form), male or female;
- Applicable to Systemic Lupus Erythematosus (SLE):
- Diagnosed with Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/1997 American College of Rheumatology (ACR) classification criteria for diagnosis.
- SLE-ITP: platelet count < 50×10^9/L in at least 2 consecutive blood routine tests; no obvious abnormalities in blood cell morphology by peripheral blood smear microscopy; bone marrow cell morphology consistent with immune thrombocytopenia; excluding thrombocytopenia caused by other non-SLE reasons, such as infection, bone marrow suppression, splenomegaly, hypersplenism, etc.; failed to achieve at least partial response after receiving at least 1 course of MP pulse therapy (1g×3 days) or high-dose hormone (1mg/kg/d equivalent glucocorticoid) combined with 1 or more immunosuppressants. Note: Complete Response (CR): platelet count ≥100×10^9/L; Partial Response (PR): platelet count 30-100×10^9/L, at least twice the pre-treatment level, and no bleeding.
- Other SLE: despite standard treatment, SLEDAI-2000 score ≥8 points and at least one BILAG Grade A or two BILAG Grade B; meeting one of the following conditions: positive antinuclear antibody (ANA) confirmed during screening, or anti-dsDNA antibody higher than normal level at screening, or anti-Sm antibody higher than normal level at screening; before the first administration of the trial drug, the subject has received at least one of the following standard treatments for 12 weeks, and the dose must be stable (dose reduction is allowed, dose increase is not allowed) for at least 30 days. Standard treatment regimens refer to stable use of any of the following: a. Antimalarial drugs combined with oral glucocorticoids (OCS, such as prednisone or equivalent dose of other hormones) and/or immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, cyclosporine, azathioprine, tripterygium wilfordii); b. OCS and/or immunosuppressant combination therapy. If the subject is receiving OCS (such as prednisone or equivalent dose of other hormones), the following conditions must be met: the maximum dose of OCS at screening and during screening is 30 mg/day prednisone (or equivalent dose of other hormones); other drugs and traditional Chinese medicines that affect immunity can be continued at the discretion of the investigator; Applicable to Idiopathic Inflammatory Myopathies (IIM):
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- Diagnosed with possible or definite Idiopathic Inflammatory Myopathies (IIM) according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for diagnosis -- possible IIM: score of 5.5 points without biopsy; definite IIM: score of 6.7 points with biopsy; meeting the definition of refractory or relapsed IIM;
- Definition of refractory IIM: receiving at least one immunosuppressant (such as azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, leflunomide, etc.) at a stable dose for more than 2 months, and when glucocorticoids are reduced to 10mg prednisone per day or equivalent dose or higher, at least one of the following deteriorations occurs: (i) progression of ILD, worsening of exertional dyspnea, or increase in ILD score on lung HRCT, or decrease in FVC% predicted value of pulmonary function by more than 5%, or decrease in DLco% by >10%; (ii) worsening of myositis, decrease in MMT-8 by >5 points/150 points, or increase in creatine kinase by >100U/L compared with previous levels;
- Definition of relapsed IIM: recurrence of active IIM causing new organ involvement or aggravation of originally involved organs after 6 months of continuous remission, or requiring an increase in glucocorticoids and immunosuppressants.
Who cannot join
- Severe lupus nephritis within 8 weeks before screening (defined as urinary protein >6 g/24 hours or serum creatinine >2.5 mg/dL or 221 μmol/L), or need to use protocol-prohibited drugs to treat active nephritis, or need hemodialysis or receive prednisone ≥100 mg/d or equivalent glucocorticoid treatment for ≥14 days;
- Central nervous system diseases caused by SLE or non-SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.);
- Other types of idiopathic inflammatory myopathies: inclusion body myositis, atrophic diabetes, juvenile myositis; patients with severe muscle damage or myositis with permanent weakness or cardiac involvement caused by non-IIM reasons (such as stroke);
- SSc-related pulmonary hypertension requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active gastric antral vascular ectasia; previous renal crisis caused by SSc;
- History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
- Concurrent with two or more immune diseases requiring systemic treatment, which the investigator deems unsuitable for enrollment;
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- Suffering from IgA deficiency (serum IgA level <10 mg/dL);
- Participation in any other clinical trial within 4 weeks before screening or within 5 half-lives of the trial drug (whichever is longer);
- Previous receipt of CAR-T therapy or other cell or gene therapy;
- Receipt of belimumab within 2 weeks before screening; receipt of B cell-depleting drugs such as rituximab or equivalent therapy (targeting CD19, CD20, BAFF, etc.) within 1 month before screening, unless it can be proven that B cells have recovered to pre-treatment levels or within the normal range;
- Receipt of anti-SLE treatment other than standard treatment (such as Saphnelo) within 3 months before screening or within 5 half-lives of the drug (whichever is longer);
- Receipt of live/attenuated vaccine within 4 weeks before screening or planned to receive live/attenuated vaccine during the trial;
- Uncontrolled active infection;
- Admission or evidence of use of illicit drugs, drug abuse, or alcoholism;
- Receipt of major surgery within 4 weeks before screening or minor surgery within 2 weeks before screening; wounds must be completely healed (surgical procedures such as catheter placement are not exclusion criteria);
- History of any of the following cardiovascular diseases within 6 months before screening: New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases with significant clinical significance;
- Any other severe underlying diseases (such as active gastric ulcer, uncontrolled epileptic seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation and coagulation dysfunction, heart disease), mental diseases, psychological, familial, or regional diseases that the investigator determines may interfere with planned staging, treatment, and follow-up, affect patient compliance, or put the patient at high risk of complications;
- Evidence of concurrent malignant tumors within <5 years before screening, except for fully treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, breast ductal carcinoma in situ, or ≤T1 urothelial carcinoma. Patients with prostate cancer under active surveillance are eligible to participate in this study;
- Pregnant or lactating women;
- Viral serological test during screening: positive for human immunodeficiency virus antibody (HIV-Ab); positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBc-Ab), and HBV-DNA copy number greater than the measurable lower limit; positive for hepatitis C antibody (HCV-Ab) and HCV-RNA copy number greater than the measurable lower limit; or subjects with positive treponema pallidum antibody (TP-Ab);
- Subjects with active or latent tuberculosis (positive T-SPOT) detected during screening;
- Receipt of splenectomy for treatment within 6 months before screening;
- Other subjects deemed unsuitable for participation in this trial by the investigator.
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
Beijing GoBroad Hospital
Beijing
Miao shaocong, 18831006667, miaosc@gobroadhealthcare.com
About this study
Official title: Exploratory Clinical Study on the Safety of STR-P004 in the Treatment of Patients With Relapsed or Refractory Autoimmune Diseases
This is an open-label, multiple-dose escalation IIT clinical study aimed at evaluating the safety, tolerability, PK, and preliminary efficacy of STR-P004 in adult patients with relapsed or refractory autoimmune diseases.
Read the detailed description
This study adopts the "TITE-BOIN12" dose escalation design. Two TITE-BOIN12 dose exploration cohorts (SLE-ITP and SLE-Other) are planned. Dose escalation and OBD selection decisions for the SLE-ITP and SLE-Other subject cohorts will be made independently based on the safety and efficacy data from their respective cohorts. Dose escalation/de-escalation and OBD decisions for the two cohorts are independent of each other. Subjects with other indications will only be enrolled at dose levels confirmed as safe by the SLE-ITP and SLE-Other cohorts (i.e., based on the DLT rate of the current dose group, where the dose escalation/de-escalation decision is not to de-escalate) and will not participate in the dose escalation or OBD selection decisions.
This study plans to include three dose groups: DL-1 xx mg/kg, DL1 xx mg/kg, and DL2 xx mg/kg. DL-1 is the backup de-escalation dose group, and the starting dose group is DL1. If one or more DLTs occur among the first three subjects enrolled in DL1 (regardless of cohort, i.e., when the total number of SLE-ITP and SLE-Other subjects enrolled in DL1 reaches three), all cohorts will de-escalate to the backup dose group, and the TITE-BOIN12 dose escalation and expansion strategy will be implemented starting from the DL-1 dose group.
- Conditions
- Autoimmune Diseases
- Being tested
- STR-P004
- Keywords
- STR-P004, Autoimmune Diseases, in-vivo Cart
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STR-P004Biological
STR-P004 Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| DL-1 STR-P004 Amg/kg | Experimental | Enrolled patients will receive Amg/kg of STR-P004 Intravenous infusion Receives: Biological: STR-P004 |
| DL1 STR-P004 Bmg/kg | Experimental | Enrolled patients will receive Bmg/kg of STR-P004 Intravenous infusion Receives: Biological: STR-P004 |
| DL2 STR-P004 Cmg/kg | Experimental | Enrolled patients will receive Cmg/kg of STR-P004 Intravenous infusion Receives: Biological: STR-P004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT), all adverse events (AEs)/serious adverse events (SAEs);
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start16 Sep 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion14 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Starna Therapeutics
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143617
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2025-063
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study on the Safety of STR-P004 in the Treatment of Patients With Relapsed or Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07143617
- Acronym / sponsor ID
- BJGBYY-IIT-LCYJ-2025-063
- Conditions
- Autoimmune Diseases
- Keywords
- STR-P004, Autoimmune Diseases, in-vivo Cart
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- Starna Therapeutics
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 14 Sep 2026 (estimated)
- First posted
- 27 Aug 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 an open-label, multiple-dose escalation IIT clinical study aimed at evaluating the safety, tolerability, PK, and preliminary efficacy of STR-P004 in adult patients with relapsed or refractory autoimmune diseases.
Detailed description
This study adopts the "TITE-BOIN12" dose escalation design. Two TITE-BOIN12 dose exploration cohorts (SLE-ITP and SLE-Other) are planned. Dose escalation and OBD selection decisions for the SLE-ITP and SLE-Other subject cohorts will be made independently based on the safety and efficacy data from their respective cohorts. Dose escalation/de-escalation and OBD decisions for the two cohorts are independent of each other. Subjects with other indications will only be enrolled at dose levels confirmed as safe by the SLE-ITP and SLE-Other cohorts (i.e., based on the DLT rate of the current dose group, where the dose escalation/de-escalation decision is not to de-escalate) and will not participate in the dose escalation or OBD selection decisions.
This study plans to include three dose groups: DL-1 xx mg/kg, DL1 xx mg/kg, and DL2 xx mg/kg. DL-1 is the backup de-escalation dose group, and the starting dose group is DL1. If one or more DLTs occur among the first three subjects enrolled in DL1 (regardless of cohort, i.e., when the total number of SLE-ITP and SLE-Other subjects enrolled in DL1 reaches three), all cohorts will de-escalate to the backup dose group, and the TITE-BOIN12 dose escalation and expansion strategy will be implemented starting from the DL-1 dose group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DL-1 STR-P004 Amg/kg | Experimental | Biological: STR-P004Enrolled patients will receive Amg/kg of STR-P004 Intravenous infusion |
| DL1 STR-P004 Bmg/kg | Experimental | Biological: STR-P004Enrolled patients will receive Bmg/kg of STR-P004 Intravenous infusion |
| DL2 STR-P004 Cmg/kg | Experimental | Biological: STR-P004Enrolled patients will receive Cmg/kg of STR-P004 Intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand the purpose, nature, method of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
- Aged ≥18 years (including the boundary value, based on the time of signing the informed consent form), male or female;
- Applicable to Systemic Lupus Erythematosus (SLE):
- Other SLE: despite standard treatment, SLEDAI-2000 score ≥8 points and at least one BILAG Grade A or two BILAG Grade B; meeting one of the following conditions: positive antinuclear antibody (ANA) confirmed during screening, or anti-dsDNA antibody higher than normal level at screening, or anti-Sm antibody higher than normal level at screening; before the first administration of the trial drug, the subject has received at least one of the following standard treatments for 12 weeks, and the dose must be stable (dose reduction is allowed, dose increase is not allowed) for at least 30 days. Standard treatment regimens refer to stable use of any of the following: a. Antimalarial drugs combined with oral glucocorticoids (OCS, such as prednisone or equivalent dose of other hormones) and/or immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, cyclosporine, azathioprine, tripterygium wilfordii); b. OCS and/or immunosuppressant combination therapy. If the subject is receiving OCS (such as prednisone or equivalent dose of other hormones), the following conditions must be met: the maximum dose of OCS at screening and during screening is 30 mg/day prednisone (or equivalent dose of other hormones); other drugs and traditional Chinese medicines that affect immunity can be continued at the discretion of the investigator; Applicable to Idiopathic Inflammatory Myopathies (IIM):
Key exclusion criteria (23 listed)
- Severe lupus nephritis within 8 weeks before screening (defined as urinary protein >6 g/24 hours or serum creatinine >2.5 mg/dL or 221 μmol/L), or need to use protocol-prohibited drugs to treat active nephritis, or need hemodialysis or receive prednisone ≥100 mg/d or equivalent glucocorticoid treatment for ≥14 days;
- Central nervous system diseases caused by SLE or non-SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.);
- Other types of idiopathic inflammatory myopathies: inclusion body myositis, atrophic diabetes, juvenile myositis; patients with severe muscle damage or myositis with permanent weakness or cardiac involvement caused by non-IIM reasons (such as stroke);
- SSc-related pulmonary hypertension requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active gastric antral vascular ectasia; previous renal crisis caused by SSc;
- History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
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 |
|---|---|---|
| STR-P004STR-P004 Intravenous infusion | Biological | DL-1 STR-P004 Amg/kg, DL1 STR-P004 Bmg/kg, DL2 STR-P004 Cmg/kg |
Primary outcome
Dose-limiting toxicity (DLT), all adverse events (AEs)/serious adverse events (SAEs);
Time frame: 12 months
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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 study testing STR-P004 in people with Autoimmune Diseases, 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 9 inclusion and 23 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 9 Mar 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.
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 Miao shaocong (18831006667, miaosc@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT), all adverse events (AEs)/serious adverse events (SAEs); (time frame: 12 months). 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 9 Mar 2026.