Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1

Inclusion Criteria:

• Age between ≥16 and ≤70 years at screening, no gender restrictions

• ECOG score of 0-1 at screening

• Newly diagnosed Ph-negative B-ALL, MRD positive(bone marrow MRD ≥0.01% by flowcytometry) in CR1 (with <5% blasts in bone marrow, no blasts in peripheral blood, noextramedullary disease)after induction chemotherapy or consolidation chemotherapy.

• Newly diagnosed Ph-positive B-ALL, MRD positive(bone marrow MRD ≥0.01% by flowcytometry or BCR-ABL1 >0.01% detected by qPCR) in CR1 (with <5% blasts in bonemarrow, no blasts in peripheral blood, no extramedullary disease) .

• At diagnosis of B-ALL,CD19 expression of leukemic cells is positive by flowcytometry in bone marrow or peripheral blood.

• Appropirate organ function, meeting the following criteria:

1. Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);

2. Alanine aminotransferase (ALT) ≤3 times ULN;

3. Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, totalbilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN);

4. Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using theCockcroft-Gault formula);

5. International Normalized Ratio (INR) ≤1.5 times ULN and activated partialthromboplastin time (APTT) ≤1.5 times ULN;

6. Left ventricular ejection fraction (LVEF) ≥50%;

7. Minimum pulmonary reserve, with oxygen saturation >91% on room air;

• Meets leukapheresis standard of the study center, with no contraindications forblood cell separation;

• Voluntarily agrees to participate in this study and signs on the informed consentform(ICF).

Exclusion Criteria:

• Received CAR-T cell therapy before screening;

• Inherited bone marrow failure syndrome(IBMFS) or any other known bone marrow failuresyndromes;

• Active systemic autoimmune diseases requiring treatment;

• Any of the following conditions:

1. HBsAg and/or HBeAg positive;

2. HBe-Ab and/or HBc-Ab positive with HBV-DNA levels above the lower limit ofquantification;

3. HCV-Ab positive;

4. TP-Ab positive;

5. HIV antibody positive;

6. EBV-DNA or CMV-DNA levels above the lower limit of quantification;

• Active infection at screening.

• Any other malignancy within the past five years before screening, excluding caseswhere the patient has been disease-free for more than 5 years after curativetreatment or has a low risk of relapse as assessed by the investigator;

• Any of the following cardiac conditions:

1. NYHA Class III or IV congestive heart failure;

2. Severe arrhythmia requiring treatment;

3. Uncontrolled hypertension or pulmonary hypertension despite standard therapy;

4. Unstable angina;

5. Myocardial infarction, bypass surgery, or stent placement within six monthsbefore cell retransfusion;

6. Clinically significant valvular disease;

7. Other cardiac conditions deemed unsuitable by the investigator;

• History of epilepsy, cerebellar disease, or other active central nervous systemdisorders;

• Uncontrolled diabetes;

• History of symptomatic deep vein thrombosis or pulmonary embolism within six monthsbefore screening that is not well controlled;

• History of hypersensitivity to any component of the investigational product.

• Received a live vaccine within six weeks before screening;

• Life expectancy of less than three months;

• Participation in another interventional clinical trial and receiving investigationaldrugs within three months (for unapproved drugs) or within five half-lives (forapproved drugs) before cell infusion, or plans to participate in another clinicaltrial or receive anti-cancer therapy outside the study protocol during the studyperiod;

• Other conditions deemed unsuitable for participation in this clinical trial by theinvestigator.