OncoMatch/Clinical Trials/NCT06793241
Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia
Is NCT06793241 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells for b-cell acute lymphoblastic leukemia.
Treatment: CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells — A Clinical Study on the Safety and Effectiveness of donor derived CD19 CAR-T Cells in the treatment of R/R B-cell acute lymphoblastic leukemia
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — standard or remedial
No CR was obtained after standard chemotherapy; CR was induced for the first time, but the duration of CR was less than 12 months; R/R B-ALL that does not work after the first or more remedial treatments; Two or more relapses
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: allowed if ≥100 days since transplant
Less than 100 days after receiving allogeneic hematopoietic stem cell transplantation
Cannot have received: anti-cancer chemotherapy or other drugs
Exception: allowed if >2 weeks prior to screening
Patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening
Lab requirements
Blood counts
Absolute neutrophil count: ≥ 0.5×10^9/L; Platelet: ≥ 30×10^9/L; Hemoglobin ≧60g/L
Kidney function
creatinine ≤176.8 (μmol/L)
Liver function
Total bilirubin ≤51 (μmol/L), ALT/AST ≤ 3 times the upper limit of normal
Cardiac function
Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%
Total bilirubin ≤51 (μmol/L), ALT/AST ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L); Absolute neutrophil count: ≥ 0.5×10^9/L; Platelet: ≥ 30×10^9/L; Hemoglobin ≧60g/L; Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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