This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia.
Aged ≥3 and ≤70 years, gender and race unrestricted.
Ph+ALL subjects are eligible if they meet one of the following criteria: ① Relapse or 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 receive at least two TKI treatments; or ② Unable to tolerate TKI treatment; or ③ Contraindications 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 is detected during the screening period.
ECOG score 0-2;
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;
Single group
RD06-03 cell injection
DrugThe patients in this intervention will use RD06-03 cell injection with 3 dose dose 1: 1×10\^5 CAR+ T Cells/kg dose 2: 3×10\^5 CAR+ T Cells/kg dose 3: 5×10\^5 CAR+ T Cells/kg Dosage form: IV injection Frequency of administration：1 time
Dose-limiting toxicity
DLT
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