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

Inclusion Criteria: Age ≥14 years, gender is not limited; Patients with clinically diagnosed relapsed/refractory B-ALL (except those presenting with extramedullary disease only), including any of the following: Failure to obtain CR after 2 cycles of standard chemotherapy; First induction of CR, but duration of CR is ≤12 months; Relapsed/refractory B-ALL that has failed to respond to the first or multiple salvage treatments; Relapse after hematopoietic stem cell transplantation, including hematological relapse and positive micro residual disease (MRD). Cytological or histological confirmation of tumor cell immunophenotyping as CD19 positive; Bone marrow with a ratio of ≥5% primitive/naïve lymphocytes (morphology); Expected survival time of more than 3 months; Eastern Cooperative Oncology Group (ECOG) score of 0-2; Vital organ function meets the following requirements: left ventricular ejection fraction ≥50% on echocardiography; serum creatinine≤1.5 × upper limit of normal range (ULN); glutamine aminotransferase, aspartate aminotransferase ≤3 times ULN, total bilirubin ≤1.5 times ULN; Pregnancy tests for women of childbearing age should be negative, and both men and women should agree to use effective contraception during treatment and for the following 1 year. Toxicity of prior antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or acceptable inclusion/exclusion criteria level. 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. Exclusion Criteria: 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.