Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005

NCT07605637 | Not Yet Recruiting

• 1 other identifier: BJGBYY-IIT-LCYJ-2026-031
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in participants with relapsed/refractory autoimmune diseases. The study will employ a traditional "3+3" dose-escalation design, with 3 dose groups: XXmg/kg, XXmg/kg, XXmg/kg. Dose Group 1 is the starting dose. This group includes two cohorts, A and B, to optimize the dosing frequency of STR-P005. Cohort A will receive doses Q3D (once every 3 days) on Days 1, 4, 7 (3 doses per cycle), for up to 2 cycles. Cohort B will receive doses Q4D (once every 4 days) on Days 1, 4 (2 doses per cycle), for up to 2 cycles. Based on preliminary safety, efficacy, PK/PD data from Cohorts 1A and 1B, the superior regimen will be selected for escalation to Dose Groups 2 and 3. If no optimal dose is identified after escalating through the 3 dose groups, additional higher doses may be explored after SRC discussion based on all accumulated preliminary safety, efficacy, and PK/PD data to further evaluate the safety and efficacy of STR-P005.

Conditions

Relapsed/Refractory Autoimmune Diseases

Keywords

SLE; dcSSc; ANCA; AAV; IIM; SS

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  12 months

Study Arms (1)

Dose1

EXPERIMENTAL

Drug: STR-P005 dose group

Interventions

STR-P005 dose group DRUG

STR-P005 infusion

Dose1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily participate and sign informed consent. 2. Age 18 to 75 years (inclusive). 3. Confirmation of positive CD19 expression on peripheral blood B cells by flow cytometry.
• \. Adequate organ function:
• Hematology: Absolute neutrophil count (ANC) ≥1.0×10\^9\^/L, absolute lymphocyte count (ALC) ≥0.1×10\^9\^/L, hemoglobin ≥80 g/L, platelet count (PLT) ≥50×10\^9\^/L. Transfusion and growth factors cannot be used within 7 days prior to screening to meet these requirements.
• Coagulation: International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
• Liver function: Serum AST, ALT ≤3.0 × ULN, total bilirubin ≤1.5 × ULN (for participants with Gilbert's syndrome, total bilirubin \<3.0 × ULN).
• Renal function: Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥60 mL/min (Cockcroft Gault formula); if renal involvement, CrCl ≥45 mL/min. \|
• Cardiac function: New York Heart Association (NYHA) class I or II, left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO), and no clinically significant arrhythmia, pericardial effusion, valvular disease, or ischemic heart disease (IHD) within 8 weeks prior to screening.
• Oxygen saturation: ≥92% while breathing room air at rest (by pulse oximetry); no clinically significant pleural effusion.

You may not qualify if:

• Previous treatment with any cellular immunotherapy, unless there is evidence that engineered immune cells have disappeared and B cells are still present in peripheral blood.
• Failure to meet the following treatment washout periods:
• Use of therapeutic doses of corticosteroids (prednisone ≥20 mg/day or equivalent) within 72 hours before first dose, though topical or inhaled steroids are allowed.
• Use of mycophenolate mofetil or its derivatives, azathioprine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mTOR inhibitors (e.g., sirolimus, everolimus), JAK inhibitors (e.g., tofacitinib, ruxolitinib, upadacitinib) within at least 2 weeks before screening.
• Use of cytotoxic drugs such as cyclophosphamide, methotrexate within at least 3 weeks before screening.
• Use of belimumab, B-cell targeting antibodies (e.g., anti-CD20) within at least 1 month or more; anti-cytokine antibodies within at least 2 months; natalizumab, anti-CD52, anti-CD38, ATG within at least 3 months before screening.
• Other monoclonal, bispecific, trispecific antibodies, ADCs, or any B-cell depleting drugs must be washed out for 3 months or 5 half-lives (whichever is shorter) before screening.
• Undergone plasmapheresis, plasma separation, hemodialysis, IVIG within 2 weeks before screening.
• History of ≥ Grade 2 bleeding within 30 days before screening; or requiring long-term continuous use of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors), unless INR ≤1.5 × ULN.
• Severe renal disease: Severe lupus nephritis within 8 weeks before screening \[defined as urine protein \>6g/24h or serum creatinine \>2.5 mg/dL or 221 μmol/L or CrCl (Cockcroft Gault) \<30 mL/min\], or active nephritis requiring treatment with prohibited medications, or requiring prednisone \>100 mg/day or equivalent corticosteroid therapy for ≥14 days.
• Severe pulmonary disease within 3 months before screening, such as moderate-to-severe pulmonary arterial hypertension (mean pulmonary artery pressure \>60 mmHg by ECHO), requiring oxygen therapy via mask or non-invasive/invasive mechanical ventilation at screening.
• History of lupus crisis within 3 months before screening, such as active CNS lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc.
• History or symptoms of active non-lupus-related CNS disease within 6 months before screening (excluding isolated trigeminal nerve disease), including but not limited to: cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, etc., as well as symptoms like epilepsy, convulsions, aphasia, dementia.
• Occurrence of any of the following cardiovascular diseases within 6 months before screening (including but not limited to):
• Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary/peripheral artery bypass grafting.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• Starna Therapeutics: collaborator

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share