OncoMatch/Clinical Trials/NCT06393335
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research
Is NCT06393335 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Metabolically Armed CD19 CAR-T cells for acute lymphoblastic leukemia.
Treatment: Metabolically Armed CD19 CAR-T cells — A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression
Positive CD19 expression comfirmed by immunohistochemistry or flow cytometry.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CD20 antibody (rituximab) — B-NHL
Patients who have been treated with CD20 antibodies (such as rituximab) and at least two chemotherapy regiments, one of which should include anthracyclines.
Must have received: anthracycline — B-NHL
at least two chemotherapy regiments, one of which should include anthracyclines
Must have received: tyrosine kinase inhibitor — Ph+ B-ALL
Philadelphia-chromosome-positive (Ph+) patients who do not achieve CR or relapse after being treated with at least two tyrosine kinase inhibitors (TKI).
Cannot have received: CD19 CAR-T cell therapy
Exception: allowed if at least 30 days since last CD19-CAR T cell therapy
For participants who had failed prior CD19-CAR T cell therapy: at least 30-days has elapsed since participant received last CD19-CAR T cell therapy.
Lab requirements
Blood counts
ALC ≥ 0.5×10^9/L (except for those receiving bridging chemotherapy); Platelet ≥ 25×10^9/L; Hemoglobin ≥ 70.0 g/L
Kidney function
Serum creatinine ≤ 1.5×ULN or Creatinine Clearance ≥ 40 mL/min
Liver function
ALT ≤ 2.5×ULN; AST ≤ 2.5×ULN; TBIL ≤ 2×ULN (≤ 3×ULN for Gilbert-Meulengracht syndrome); DBIL ≤ 1.5×ULN; ALP ≤ 2.5×ULN; if bone or liver metastases present, AST, ALT, ALP ≤ 5×ULN
Cardiac function
LVEF ≥ 45%
CBC test results should meet the following criteria... Serum creatinine (Scr) ≤ 1.5× ULN, or Creatinine Clearance (Ccr) ≥ 40 mL/min... ALT ≤ 2.5×ULN... LVEF ≥ 45％
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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