OncoMatch/Clinical Trials/NCT06752785
CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
Is NCT06752785 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CAR-T Therapy for acute lymphoblastic leukemia.
Treatment: CAR-T Therapy — In this study, CD19/CD22 dual-target CAR-T therapy will be carried out among children patients who are still positive after induction remission, and subsequent chemotherapy will continue after CAR-T cells exert their functions. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19/CD22 to treat MRD-positive ALL. The CAR-T cells were provided by Shenzhen Cell Valley. The results of the research team from Stanford University School of Medicine in the United States have already demonstrated the feasibility and safety of producing bispecific CD19/CD22.BB.z-CAR T cells in a closed system as well as the high clinical activity shown in the treatment of CAR19-resistant B-ALL (B-lineage acute lymphoblastic leukemia) and LBCL (Large B-cell lymphoma). The investigators look forward to expanding the application of CAR-T cells in MRD positive B-ALL through this clinical study on safety and efficacy and greatly improving the prognosis of children patients with this type of B-ALL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression
Required: CD22 expression
Prior therapy
Must have received:
induction remission
Lab requirements
Kidney function
serum creatinine ≤ 1.5x ULN
Liver function
ALT ≤ 5x ULN; total bilirubin ≤ 2x ULN (Gilbert's syndrome ≤ 3x ULN)
Cardiac function
LVEF ≥ 50%; without > grade 1 dyspnea when not inhaling oxygen, and oxygen saturation > 95%
Good organ function, which needs to meet the following criteria: (1)ALT ≤ 5 times the upper limit of normal value (ULN); (2)total bilirubin ≤ 2 times ULN (Gilbert's syndrome ≤ 3 times ULN); (3)without > grade 1 dyspnea when not inhaling oxygen, and oxygen saturation > 95%; (4)left ventricular ejection fraction (LVEF) ≥ 50%; (5)serum creatinine ≤ 1.5 times ULN.
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