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

Exclusion criteria

• . 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.