Clinical Trial of CD38 Monoclonal Antibody Combined With Chemotherapy for T-Cell Acute Lymphoblastic Leukemia

Inclusion Criteria:

* Diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) according to the World Health Organization (WHO) 2022 classification or International Consensus Classification (ICC) criteria.
* Age ≥14 years, regardless of gender.
* CD38-positive expression on leukemic cells, confirmed by multicolor flow cytometry.
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
* Laboratory parameters (assessed within 7 days prior to treatment):

Total bilirubin ≤1.5 × upper limit of normal (ULN) for the corresponding age group.

AST and ALT ≤2.5 × ULN for the corresponding age group.

Serum creatinine \<2 × ULN for the corresponding age group.

Cardiac enzymes \<2 × ULN for the corresponding age group.

Left ventricular ejection fraction (LVEF) \>50%, measured by echocardiography (ECHO).

Informed Consent Requirements:

A written informed consent form must be signed prior to any study-specific procedures. The consent may be provided by the patient themselves, their legal guardian, or immediate family member. If obtaining consent directly from the patient is deemed clinically inappropriate or detrimental to the patient's treatment, consent must be obtained from the legal guardian or immediate family member.

Exclusion Criteria:

* Active central nervous system (CNS) leukemia or clinical manifestations of isolated extramedullary involvement of ALL.
* Relapsed/refractory patients (however, prior cytoreductive therapies such as hydroxyurea, corticosteroids, cyclophosphamide, or cytarabine are permitted).
* Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) \<60% of predicted value, confirmed by pulmonary function testing.
* Moderate to severe persistent asthma within the past 2 years, or uncontrolled asthma of any type at screening.
* Positive serology for human immunodeficiency virus (HIV).
* Positive syphilis serology.
* Suspected or confirmed active tuberculosis (TB) infection.
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as:

  1. Hepatitis B surface antigen (HBsAg)-positive;
  2. Hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA;
  3. Anti-HCV antibody-positive with detectable HCV RNA.
* Concurrent malignancies of other organ systems requiring active therapy.
* Active cardiac disease, defined as any of the following:

  1. History of uncontrolled or symptomatic angina;
  2. Myocardial infarction within 6 months prior to study enrollment.
  3. History of arrhythmias requiring pharmacologic treatment or clinically significant arrhythmia;
  4. Uncontrolled or symptomatic congestive heart failure (CHF) \> New York Heart Association (NYHA) Class II;
* Severe uncontrolled active infection.
* Psychiatric disorders that may compromise the patient's ability to complete treatment or provide informed consent.
* Any other condition deemed by the investigator to render the patient unsuitable for study participation.