Autoimmune DiseasesNCT07363954
To Evaluate the Safety and Tolerability of STR-P004 for the Treatment of Immune-mediated Kidney Diseases
A study testing STR-P004 dose group in people with Autoimmune Diseases, run by Starna Therapeutics.
Trial summary
This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XX mg/kg, DL2 XXmg/kg, DL3 XXmg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- STR-P004 dose group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 1 Feb 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Willing and able to provide written informed consent. 2. Age between 18 and 75 years (inclusive). 3. Confirmed CD19-positive B cell expression in peripheral blood by flow cytometry.
- 4.Adequate organ function:
- Bone marrow function: defined as absolute neutrophil count (ANC) ≥1500 /μL, absolute lymphocyte count (ALC) ≥100 /μL, hemoglobin (Hb) ≥80 g/L, platelet count (PLT) ≥50,000 /μL. Use of transfusions or growth factors to meet these requirements within 7 days prior to screening is not allowed.
- Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN, total bilirubin <1.5×ULN (<3.0×ULN for subjects with Gilbert's syndrome).
- Coagulation function: defined as International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Pulmonary function: defined as ≤ CTCAE Grade 1 dyspnea and oxygen saturation (SpO2) ≥92% on room air at rest (by pulse oximetry).
- 5. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must agree to use highly effective contraceptive methods from signing ICF until 1 year after STR-P004 infusion (including during study treatment interruption). Male subjects with partners of childbearing potential must agree to use effective barrier contraception methods for 1 year after STR-P004 infusion and should not donate semen or sperm during the entire study period.
- 6. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and within 48 hours prior to STR-P004 infusion. Women who have undergone sterilization or are postmenopausal for at least 2 years are considered not of childbearing potential.
Who cannot join
- 1. Any clinically significant underlying disease, other than SLE/LN, AAV/AAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, that, in the investigator's opinion, poses a safety risk or problem.
- 2. Rapidly progressive glomerulonephritis not related to SLE/LN, AAV/AAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, defined as ≥50% reduction in eGFR within 3 months since diagnosis.
- 3. Other uncontrolled serious conditions not directly related to the disease prior to screening, such as severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe pneumonia or pulmonary hemorrhage, severe hepatitis, severe vasculitis, active central nervous system symptoms including cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
About this study
Official title: A Clinical Study on the Safety, Efficacy, and Pharmacokinetics of STR-P004 for the Treatment of Immune-Mediated Kidney Diseases
This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XX mg/kg, DL2 XXmg/kg, DL3 XXmg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained.
Read the detailed description
This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained.
After dose escalation is completed, the investigator and collaborator may select 1 or 2 dose groups for an expansion cohort study (or during dose escalation). Each dose group will enroll an additional 3-6 subjects to evaluate efficacy and determine the RP2D.
This study aims to determine the safety, tolerability, and RP2D of STR-P004 in subjects with immune-mediated kidney diseases. The study will also evaluate the PK characteristics of STR-P004 and provide preliminary efficacy observations
- Conditions
- Autoimmune Diseases
- Being tested
- STR-P004 dose group
- 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-P004 dose groupDrug
Three dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Dose1 | Experimental | Not described Receives: Drug: STR-P004 dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT, SAE, and Treatment-Emergent Adverse Events (TEAE).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363954
- Sponsor's protocol ID
- STR-P004-005
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety, Efficacy, and Pharmacokinetics of STR-P004 for the Treatment of Immune-Mediated Kidney Diseases
- ClinicalTrials.gov ID
- NCT07363954
- Acronym / sponsor ID
- STR-P004-005
- Conditions
- Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Starna TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 23 Jan 2026 (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, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XX mg/kg, DL2 XXmg/kg, DL3 XXmg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained.
Detailed description
This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained.
After dose escalation is completed, the investigator and collaborator may select 1 or 2 dose groups for an expansion cohort study (or during dose escalation). Each dose group will enroll an additional 3-6 subjects to evaluate efficacy and determine the RP2D.
This study aims to determine the safety, tolerability, and RP2D of STR-P004 in subjects with immune-mediated kidney diseases. The study will also evaluate the PK characteristics of STR-P004 and provide preliminary efficacy observations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose1 | Experimental | Drug: STR-P004 dose group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Willing and able to provide written informed consent. 2. Age between 18 and 75 years (inclusive). 3. Confirmed CD19-positive B cell expression in peripheral blood by flow cytometry.
- 5. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must agree to use highly effective contraceptive methods from signing ICF until 1 year after STR-P004 infusion (including during study treatment interruption). Male subjects with partners of childbearing potential must agree to use effective barrier contraception methods for 1 year after STR-P004 infusion and should not donate semen or sperm during the entire study period.
- 6. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and within 48 hours prior to STR-P004 infusion. Women who have undergone sterilization or are postmenopausal for at least 2 years are considered not of childbearing potential.
Key exclusion criteria (3 listed)
- 1. Any clinically significant underlying disease, other than SLE/LN, AAV/AAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, that, in the investigator's opinion, poses a safety risk or problem.
- 2. Rapidly progressive glomerulonephritis not related to SLE/LN, AAV/AAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, defined as ≥50% reduction in eGFR within 3 months since diagnosis.
- 3. Other uncontrolled serious conditions not directly related to the disease prior to screening, such as severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe pneumonia or pulmonary hemorrhage, severe hepatitis, severe vasculitis, active central nervous system symptoms including cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
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-P004 dose groupThree dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg. | Drug | Dose1 |
Primary outcome
Incidence of DLT, SAE, and Treatment-Emergent Adverse Events (TEAE).
Time frame: 3 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 23 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing STR-P004 dose group in people with Autoimmune Diseases, run by Starna Therapeutics.
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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT, SAE, and Treatment-Emergent Adverse Events (TEAE). (time frame: 3 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 23 Jan 2026.