Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies

Korábbi kezelés

• History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
• Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
• Patients who have participated in other clinical studies within 1 month prior to screening.

Más betegség

• Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ.
• Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc.

Egyéb

• Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents.
• Evidence of central nervous system involvement at the time of screening.

• Aged 18 to 70 years (inclusive), irrespective of sex and race.
• Life expectancy greater than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.
• Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive hematolymphoid malignancy
• Adequate hepatic, renal, and cardiopulmonary function
• Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL