The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia

Inclusion Criteria:

• Aged ≥3 and ≤70 years, gender and race unrestricted.

• Bone marrow examination confirms the diagnosis of acute B-cell lymphoblasticleukemia (B-ALL) and meets one of the following conditions:

Relapsed B-ALL: ① Relapse within 12 months after the first remission; or ② Relapse after salvage chemotherapy in first-line/multi-line treatment; or ③ Relapse after autologous or allogeneic hematopoietic stem cell transplantation; Refractory B-ALL: ① Failure to achieve complete remission after 2 cycles of standardized induction chemotherapy; or ② Failure to achieve complete remission after salvage chemotherapy in first-line/multi-line treatment;

• Ph+ALL subjects are eligible if they meet one of the following criteria: ① Relapseor refractory after receiving at least 2 tyrosine kinase inhibitors (TKIs)treatments; if accompanied by TKI-resistant mutations such as T315I/A, V299L,F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I, subjects are not required to receiveat least two TKI treatments; or ② Unable to tolerate TKI treatment; or ③Contraindications to TKI treatment.

• The proportion of bone marrow blasts during the screening period is ≥5% (morphological).Expression of CD19 on bone marrow or peripheral blood tumor cells isdetected during the screening period.

• Organ function and laboratory tests meet the following criteria:

Serum total bilirubin <2× upper limit of normal (ULN), serum ALT and AST both <3× ULN, serum creatinine <1.5× ULN; Coagulation function: International normalized ratio (INR) ≤1.5× ULN, or prothrombin time (PT) ≤1.5× ULN; Transthoracic echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; Resting oxygen saturation (SpO2) ≥92% in ambient air; Estimated survival period of more than 3 months;

• ECOG score 0-2;

• Fertile women must agree to use highly effective contraception from at least 28 daysbefore leukapheresis to 6 months after CAR-T cell infusion. Their partners, fertilemen, must agree to use effective barrier contraception from the start ofleukapheresis to 6 months after CAR-T cell infusion, and should not donate semen orsperm during the entire trial period.

Exclusion Criteria:

• Suffering from genetic syndromes such as Fanconi anemia, Kostmann syndrome,Shwachman syndrome, or any other known bone marrow failure syndromes;

• History of allergy to any component of the cellular product;

• Presence of active central nervous system leukemia (CNSL) at screening;

• Patients with purely extramedullary relapse;

• Received allogeneic hematopoietic stem cell transplantation (HSCT) within 3 monthsbefore screening or experienced grade II to IV active graft-versus-host disease (GVHD) within 4 weeks before infusion;

• Significant cardiovascular dysfunction within 12 months before screening, includingbut not limited to: New York Heart Association (NYHA) class III or IV heart failure,myocardial infarction, unstable angina, uncontrolled or symptomatic atrialarrhythmias, any ventricular arrhythmias.

Presence or suspicion of uncontrollable active infection requiring intravenous therapy (excluding simple urinary tract infections, bacterial pharyngitis);

• Subjects with a history of other primary cancers, excluding the following:

Non-melanoma skin cancers such as basal cell carcinoma that have been cured by resection; Cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ with disease-free survival ≥2 years after adequate treatment;

• Subjects with autoimmune diseases requiring treatment, immunodeficiency, orrequiring immunosuppressive therapy;

• Received live attenuated vaccines within 4 weeks before screening, or planned toreceive live attenuated vaccines during the study.