To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
The primary objective: To evaluate the efficacy of S1904 in pediatric and adult subjects with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia. The secondary objectives: To further characterize the efficacy and safety profiles of S1904 in this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Autologous CD19-targeting CAR T cells
Peking University People's Hospital
Beijing, China
RECRUITINGObjective response rate after S1904 infusion [Effectiveness]
Independent Review Committee (IRC)-assessed ORR (CR + CRi) at Month 3 post-infusion, as per ALL Response Criteria.
Time frame: 3 months
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