UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.

Korábbi kezelés

• Malignant tumors other than CD19-positive hematologic malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical resection, and breast ductal carcinoma in situ after radical resection;
• Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), and serious arrhythmia;
• Within 7 days before screening, there is active infection or uncontrollable infection requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection);
• Screening participants (except for inhalation or local use) who were receiving systemic steroid treatment within 7 days before screening or who were judged by the investigator to require long-term systemic steroid therapy during treatment;
• Participated in other clinical studies within 3 month before screening;

Más betegség

• Those with graft-versus-host disease (GVHD) or requiring long-term systemic immunosuppressants;
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer outside the normal reference range; Those who are positive for hepatitis C virus (HCV) antibodies and positive for hepatitis C virus (HCV) RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody positive person; Positive for cytomegalovirus (CMV) DNA testing; those who test positive for syphilis;
• Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
• Conditions that the investigators considered unsuitable for enrollment.

Egyéb

• Pregnant or lactating women, female subjects who planned to conceive within 1 year of cell infusion or male subjects whose partner planned pregnancy within 1 year of their cell infusion;
• There was evidence of central nervous system involvement at participant screening;

• Patients aged between 3~70 (including cut-off values), regardless of gender and race;
• Expected survival time>12 weeks;
• ECOG score 0-2;
• CD19-positive relapsed/refractory B-cell hematolymphatic malignancies;
• Liver and kidney function, cardiopulmonary function meet the following requirements:
  • Creatinine ≤ 1.5 ULN;
  • Left ventricular ejection fraction ≥ 45%;
  • blood oxygen saturation>91%;
  • Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
• Be able to understand the trial and have signed the informed consent.