OncoMatch/Clinical Trials/NCT05768529
Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Is NCT05768529 recruiting? Yes, currently enrolling (Jun 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 overexpression (CD20-positive by IHC)
CD20-positive B-cell non-Hodgkin's lymphoma with immunohistochemistry(IHC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT05768529 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require MS4A1?
Yes, MS4A1 overexpression 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