Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing GoBroad Hospital
About this trial
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.
Eligibility criteria
Qualifiers
1. 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.
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).
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- STR-P005 dose group
Treatment groups
18 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Beijing GoBroad Hospital
Lead sponsor
Starna Therapeutics
Collaborator
Source ClinicalTrials.gov