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

NCT07655453 | Not Yet Recruiting

• 1 other identifier: STR-P005-004
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study 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 subjects with relapsed/refractory autoimmune diseases. The study will employ the traditional "3+3" dose escalation model, setting up 3 dose groups: Amg/kg, Bmg/kg, C mg/kg. Dose Group 1 will serve as the starting dose, with two cohorts A and B within this group aimed at optimizing the dosing frequency of STR-P005. Cohort A will receive dosing every 3 days (Q3D), on D1, D4, D7 (3 doses) constituting one cycle, which can be repeated for 2 cycles. Cohort B will receive dosing every 4 days (Q4D), on D1, D4 (2 doses) constituting one cycle, which can be repeated for 2 cycles. Based on the preliminary safety data, efficacy information, and PK/PD parameters obtained from Cohorts 1A and 1B, the investigators will select the superior regimen and escalate sequentially to Dose Groups 2 and 3. If no MTD is found after dose escalation through the 3 groups, based on all available preliminary safety data, efficacy information, and PK/PD parameters, higher doses may be added for further exploration of safety and efficacy after discussion by the SRC.

Conditions

Relapsed/Refractory Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• Grade and frequency of Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory abnormalities, and Adverse Events of Special Interest by CTCAE v6.0

  24 months

Study Arms (1)

STR-P005 Dose group

EXPERIMENTAL

Drug: STR-P005

Interventions

STR-P005 DRUG

Dose escalation follows the traditional "3+3" design, with multiple, multi-cycle intravenous infusions

STR-P005 Dose group

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 in this study and sign the informed consent form.
• Aged 18 to 75 years (inclusive).
• 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. Blood transfusion and growth factors cannot be used within 7 days prior to eligibility 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 subjects with Gilbert's syndrome, Total Bilirubin \<3.0 × ULN).
• Renal function: Serum creatinine ≤1.5 × ULN or Creatinine Clearance (CrCl) ≥60 mL/min (calculated by Cockcroft-Gault formula); if with renal involvement, CrCl ≥45 mL/min.
• Cardiac function: New York Heart Association (NYHA) Class I or II, and 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:

• Patients who have received any cell immunotherapy in the past, except where there is evidence that the engineered immune cells have disappeared and peripheral blood B cells are still present.
• Unable to meet the following washout periods for therapeutic drugs:
• Use of therapeutic doses of corticosteroids (Prednisone ≥20mg/day or equivalent dose of other corticosteroids) within 72 hours prior to first dose, but 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 prior to screening.
• Use of cytotoxic drugs such as cyclophosphamide, methotrexate within at least 3 weeks prior to screening.
• Use of belimumab, B-cell targeting antibodies (e.g., anti-CD20) within at least 1 month prior to screening; anti-cytokine antibodies within at least 2 months; natalizumab, anti-CD52 mAb, anti-CD38 mAb, ATG within at least 3 months.
• Other monoclonal antibodies, bispecific antibodies, trispecific antibodies, antibody-drug conjugates (ADC), or any B-cell depleting drugs require a washout of 3 months or 5 half-lives (whichever is shorter) prior to screening.
• Undergone plasmapheresis, plasma separation, hemodialysis, intravenous immunoglobulin (IVIG) within 2 weeks prior to screening.
• History of ≥ Grade 2 bleeding within 30 days prior to screening; or requiring long-term continuous use of anticoagulants (e.g., warfarin, low molecular weight heparin, or Factor Xa inhibitors), except if INR ≤ 1.5 × ULN.
• Severe renal disease: Severe lupus nephritis within 8 weeks prior to screening \[defined as urine protein \> 6g/24 hours or serum creatinine \> 2.5 mg/dL or 221 μmol/L or creatinine clearance (Cockcroft-Gault formula) \< 30 mL/min\], or active nephritis requiring treatment with prohibited medications, or requiring prednisone \>100mg/day or equivalent corticosteroid for ≥14 days.
• Severe pulmonary disease within 3 months prior to screening, such as moderate-to-severe pulmonary hypertension (mean pulmonary artery pressure \> 60 mmHg by echocardiography), requiring oxygen therapy via reservoir mask or non-invasive/invasive mechanical ventilation at screening.
• Occurrence of lupus crisis within 3 months prior to screening, such as active central nervous system 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 related symptoms of active non-lupus-induced central nervous system disease (excluding isolated trigeminal nerve disease) within 6 months prior to screening, including but not limited to: cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, and symptoms such as epilepsy, convulsions, aphasia, dementia, etc.
• Occurrence of any of the following cardiovascular diseases within 6 months prior to screening (including but not limited to):
• Congestive heart failure, myocardial infarction, unstable angina pectoris, coronary angioplasty, stent implantation, coronary/peripheral artery bypass surgery.

Sponsors & Collaborators

• Starna Therapeutics: lead

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06