OncoMatch/Clinical Trials/NCT05768529
Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Is NCT05768529 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies U16 for relapsed or refractory non-hodgkin's lymphoma.
Treatment: U16 — The study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 overexpression (CD20-positive by IHC)
CD20-positive B-cell non-Hodgkin's lymphoma with immunohistochemistry(IHC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline
Received anthracycline-containing drugs
Must have received: CD20-targeted therapy (rituximab)
rituximab or other CD20-targeted drugs (except CD20-negative tumors)
Cannot have received: CAR-T cell therapy
Exception: CD20 target
Patients previously received CAR-T cell therapy with CD20 target
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: within 6 months before signing the informed consent form
Received allogeneic hematopoietic stem cell transplantation within 6 months before signing the informed consent form
Lab requirements
Blood counts
ANC ≥1.0×10^9/L; ALC ≥ 0.3×10^9/L; Platelet ≥50×10^9/L
Kidney function
Serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
AST ≤ 3 ULN; ALT ≤ 3 ULN (≤5 ULN if hepatic dysfunction due to tumor cell infiltration); Total serum bilirubin ≤ 2 ULN (≤3 ULN with Gilbert syndrome and direct bilirubin ≤ 1.5 ULN)
Adequate bone marrow reserve, defined as: Absolute neutrophil count (ANC) ≥1.0×10^9/L; Absolute lymphocyte count (ALC) ≥ 0.3×10^9/L; Platelet (PLT) ≥50×10^9/L; Proper organ function, defined as: AST ≤ 3 ULN; ALT ≤ 3 ULN (≤5 ULN if hepatic dysfunction due to tumor cell infiltration); Total serum bilirubin ≤ 2 ULN, unless there exists concurrent Gilbert syndrome; patients with Gilbert syndrome, with total serum bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN, may be included; Serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); Minimum pulmonary reserve, defined as Grade ≤ 1 dyspnea, and blood oxygen saturation > 91% at non-oxygen inhalation status
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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