A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia
The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed/refractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia. Interim analysis conducted when 2 patients complete primary endpoint measurement.
• Aged 18 to 75 years (inclusive), male or female;
• Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL) confirmed by the WHO 2016 Classification, or Autoimmune Hemolytic Anemia (AIHA) diagnosed in accordance with international consensus;
• Disease progression or recurrence after at least second-line drug treatment;
• CD19 positivity confirmed by flow cytometry and/or histopathology (excluding autoimmune hemolytic anemia);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1(excluding autoimmune hemolytic anemia);
• Expected survival period \> 12 weeks
• For participants with hematological malignancies, the following requirements must be met:
⁃ For any prior systemic therapy (excluding immune checkpoint inhibitors), an interval of at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed between the last dose of such therapy and the planned initiation of study treatment.
⁃ For any prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), an interval of at least 3 half-lives or 28 days (whichever is shorter) must have elapsed between the last dose of such treatment and the planned initiation of study treatment.
⁃ • For participants with autoimmune hemolytic anemia (AIHA), the following requirements must be met: The total course of glucocorticoid therapy shall be no less than 3 months (except for those who are unable to tolerate due to severe infection, fracture, etc.); Rituximab (100 mg or 375 mg/m²) shall be administered for at least 4 times, with hemoglobin (HB) remaining below 100 g/L at 12 weeks after the first dose; or rituximab (1000 mg per administration) shall be administered for at least 2 times, with hemoglobin (HB) remaining below 100 g/L at 12 weeks after the first dose; oral administration of any one of the following drugs including mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide, etc., shall last for at least 4 months or be discontinued due to intolerance; or intravenous therapy with fludarabine or cyclophosphamide injection shall be administered for at least 2 cycles; or subcutaneous injection of bortezomib shall be administered for at least 4 times.