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OncoMatch/Clinical Trials/NCT05296070

Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma

Is NCT05296070 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Loncastuximab tesirine 150 µg/Kg and Loncastuximab tesirine 75µg/Kg for marginal zone lymphoma.

Phase 2RecruitingUniversity of MiamiNCT05296070Data as of May 2026

Treatment: Loncastuximab tesirine 150 µg/Kg · Loncastuximab tesirine 75µg/KgThe purpose of this research study is to see if loncastuximab tesirine has any benefits at dose levels researchers found acceptable in earlier studies in patients with related forms of immune cell cancers. The researchers want to find out the effects (good and bad) that loncastuximab tesirine has on the participant and the participant's condition.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD20 prior anti-CD20 antibody therapy

including at least 1 anti-CD20 antibody (cluster of differentiation antigen 20) (either as monotherapy or in combination as chemoimmunotherapy)

Excluded: CD19 prior anti-CD19 therapy

Previous treatment with anti CD19 (cluster of differentiation antigen 19 ) approaches

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: anti-CD20 antibody

including at least 1 anti-CD20 antibody (cluster of differentiation antigen 20) (either as monotherapy or in combination as chemoimmunotherapy), with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen

Cannot have received: anti-CD19 therapy

Previous treatment with anti CD19 (cluster of differentiation antigen 19 ) approaches

Cannot have received: allogeneic stem cell transplant

Exception: within the last 6 months

Allogeneic stem cell transplant within the last 6 months

Cannot have received: autologous stem cell transplant

Exception: within the last 3 months

autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment

Lab requirements

Blood counts

ANC ≥ 1.0 × 10^9/L; Hemoglobin ≥ 8.0 g/dL; Platelet count ≥ 50 × 10^9/L

Kidney function

Calculated creatinine clearance ≥ 45 mL/min by Cockcroft-Gault or eGFR ≥ 45 mL/min/1.73 m2

Liver function

Total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's syndrome eligible if indirect bilirubin elevated); ALT/AST ≤ 3.0 ULN or ≤ 5 × ULN with liver involvement

Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors): ANC ≥ 1.0 × 10^9/L; Hemoglobin ≥ 8.0 g/dL; Platelet count ≥ 50 × 10^9/L; Total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's syndrome eligible if indirect bilirubin elevated); ALT/AST ≤ 3.0 ULN or ≤ 5 × ULN with liver involvement; Calculated creatinine clearance ≥ 45 mL/min by Cockcroft-Gault or eGFR ≥ 45 mL/min/1.73 m2

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope National Medical Center · Duarte, California
  • University of Miami · Miami, Florida
  • Emory University · Atlanta, Georgia
  • Vanderbilt University · Nashville, Tennessee

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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