OncoMatch/Clinical Trials/NCT06180174
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Is NCT06180174 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MC-1-50 for b cell lymphoma.
Treatment: MC-1-50 — This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Biomarker criteria
Required: CD19 overexpression (positive)
Immunohistochemical or flow cytometry results showed positive CD19 expression
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CD20 monoclonal antibody
Have received adequate treatment with CD20 monoclonal antibody ... (except for those who are negative for CD20 and anthracyclines, or who are unable to tolerate or adapt to CD20 monoclonal antibody therapy or have other conditions in which the use of CD20 monoclonal antibody is not considered appropriate by the investigators)
Must have received: anthracycline
Have received adequate treatment with ... anthracyclines in the past (except for those who are negative for CD20 and anthracyclines, or who are unable to tolerate or adapt to CD20 monoclonal antibody therapy or have other conditions in which the use of CD20 monoclonal antibody is not considered appropriate by the investigators)
Cannot have received: CAR-T cell therapy
Patients who have received CAR-T therapy or other gene-modified cell therapy before screening
Cannot have received: allogeneic hematopoietic stem cell transplantation
Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) before screening
Lab requirements
Blood counts
neutrophils ≥1.0×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥80g/L (with bone marrow invasion, neutrophils ≥0.5×10^9/L, platelets ≥50×10^9/L)
Kidney function
Serum creatinine ≤2.0× ULN, or creatinine clearance ≥60ml/min (Cockcroft-Gault formula)
Liver function
ALT and AST ≤3.0×ULN (≤5.0×ULN for patients with liver invasion); Total bilirubin ≤1.5 ×ULN (≤3.0 ×ULN in Gilbert syndrome)
Cardiac function
cardiac echocardiography suggests cardiac ejection fraction ≥50%
The functions of important organs are basically normal: Cardiac function: cardiac echocardiography suggests cardiac ejection fraction ≥50%; Serum creatinine ≤2.0× ULN, or creatinine clearance ≥60ml/min (Cockcroft-Gault formula); ALT and AST≤3.0×ULN (≤5.0×ULN for patients with liver invasion); Total bilirubin ≤1.5 ×ULN (≤3.0 ×ULN in Gilbert syndrome); Blood oxygen saturation ≥92% in non-oxygen state; Blood routine: neutrophils ≥1.0×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥80g/L (with bone marrow invasion, neutrophils ≥0.5×10^9/L, platelets ≥50×10^9/L).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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