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

Inclusion Criteria:

1. Age ≥14 years, gender is not limited;
2. Patients with clinically diagnosed relapsed/refractory B-ALL (except those presentingwith extramedullary disease only), including any of the following:
3. Failure to obtain CR after 2 cycles of standard chemotherapy;
4. First induction of CR, but duration of CR is ≤12 months;
5. Relapsed/refractory B-ALL that has failed to respond to the first or multiplesalvage treatments;
6. Relapse after hematopoietic stem cell transplantation, including hematologicalrelapse and positive micro residual disease (MRD).
7. Cytological or histological confirmation of tumor cell immunophenotyping as CD19positive;
8. Bone marrow with a ratio of ≥5% primitive/naïve lymphocytes (morphology);
9. Expected survival time of more than 3 months;
10. Eastern Cooperative Oncology Group (ECOG) score of 0-2;
11. Vital organ function meets the following requirements: left ventricular ejectionfraction ≥50% on echocardiography; serum creatinine≤1.5 × upper limit of normal range (ULN); glutamine aminotransferase, aspartate aminotransferase ≤3 times ULN, totalbilirubin ≤1.5 times ULN;
12. Pregnancy tests for women of childbearing age should be negative, and both men andwomen should agree to use effective contraception during treatment and for thefollowing 1 year.
13. Toxicity of prior antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) oracceptable inclusion/exclusion criteria level.
14. No significant hereditary disease;
15. Be able to understand the requirements and matters of the trial and be willing toparticipate in the clinical study as required;
16. Sign the trial informed consent form.

Exclusion Criteria:

1. with uncontrolled active central nervous system leukemia (CNSL) or a history ofepilepsy, cerebrovascular disease
2. Pregnant or lactating women, or those who do not consent to the use of the drug duringand within 1 year after treatment;
3. Other malignant tumors not in remission;
4. with primary immunodeficiency or autoimmune diseases requiring immunosuppressivetherapy;
5. Patients who have received immune cell therapy within 6 months prior to enrollment anddonor lymphocyte infusion within 6 weeks prior to enrollment.
6. Patients with confirmed positive serum anti-FMC63 and DSA reactions;
7. Patients who have participated in other clinical trials within 4 weeks prior toenrollment;
8. Uncontrolled infectious or other serious diseases, including but not limited toinfections (Human Immunodeficiency Virus, acute or chronic active hepatitis B orhepatitis C), congestive heart failure, unstable angina pectoris cardiac arrhythmias,or conditions that the attending physician considers to be an unpredictable risk;
9. Uncontrollable plasma fluid, such as large pleural effusions or ascites;
10. History of stroke or intracranial hemorrhage within 3 months prior to enrollment;
11. Major surgery or trauma within 28 days prior to enrollment, or major side effects fromwhich you have not recovered;
12. History of allergy to any of the ingredients in the cellular product;
13. Inability to understand or unwillingness to sign the informed consent form;
14. Other reasons deemed by the investigator to be unsuitable for the clinical trial.