OncoMatch/Clinical Trials/NCT05768529
Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official title: A Single-arm, Open and Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of U16 Injection in the Treatment of Refractory/Recurrent B-cell Non-Hodgkin's Lymphoma (r/r B-NHL)
Is NCT05768529 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 expression (positive)
CD20-positive as demonstrated by immunohistochemistry (IHC) staining of prior tumor tissue samples or by bone marrow cells
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anthracycline
Must have received adequate treatment including anthracyclines
Must have received: CD20-targeted therapy (rituximab)
Must have received adequate treatment including ... rituximab or other CD20-targeted agents (except for CD20-negative tumors)
Cannot have received: CD20-targeted CAR-T cell therapy
Trial participants who have previously received CD20-targeted CAR-T therapy
Lab requirements
Blood counts
ANC ≥ 1.0×10⁹/L, ALC ≥ 0.3×10⁹/L, PLT ≥ 50×10⁹/L
Kidney function
Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL/min (Cockcroft and Gault formula)
Liver function
AST ≤3× ULN; ALT ≤3× ULN (≤5× ULN if hepatic function abnormalities due to tumor infiltration); total serum bilirubin ≤2× ULN (≤3× ULN for Gilbert syndrome, direct bilirubin ≤1.5× ULN)
Adequate bone marrow reserve at screening, defined as: absolute neutrophil count (ANC) ≥ 1.0×10⁹/L, absolute lymphocyte count (ALC) ≥ 0.3×10⁹/L, platelet count (PLT) ≥ 50×10⁹/L; Adequate organ function, meeting the following criteria: aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3× ULN (for hepatic function abnormalities due to tumor infiltration, AST and ALT ≤5× ULN are required); total serum bilirubin ≤2× ULN, unless accompanied by Gilbert syndrome; trial participants with Gilbert syndrome who have total bilirubin ≤3× ULN and direct bilirubin ≤1.5× ULN may be enrolled. Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL/min (Cockcroft and Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05768529 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD20-targeted CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require MS4A1?
Yes, MS4A1 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages