QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Exclusion Criteria17

• No significant hereditary disease;
• Be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required;
• Sign the trial informed consent form.
• with uncontrolled active central nervous system leukemia (CNSL) or a history of epilepsy, cerebrovascular disease
• Pregnant or lactating women, or those who do not consent to the use of the drug during and within 1 year after treatment;
• Other malignant tumors not in remission;
• with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
• Patients who have received immune cell therapy within 6 months prior to enrollment and donor lymphocyte infusion within 6 weeks prior to enrollment.
• Patients with confirmed positive serum anti-FMC63 and DSA reactions;
• Patients who have participated in other clinical trials within 4 weeks prior to enrollment;
• Uncontrolled infectious or other serious diseases, including but not limited to infections (Human Immunodeficiency Virus, acute or chronic active hepatitis B or hepatitis C), congestive heart failure, unstable angina pectoris cardiac arrhythmias, or conditions that the attending physician considers to be an unpredictable risk;
• Uncontrollable plasma fluid, such as large pleural effusions or ascites;
• History of stroke or intracranial hemorrhage within 3 months prior to enrollment;
• Major surgery or trauma within 28 days prior to enrollment, or major side effects from which you have not recovered;
• History of allergy to any of the ingredients in the cellular product;
• Inability to understand or unwillingness to sign the informed consent form;
• Other reasons deemed by the investigator to be unsuitable for the clinical trial.