OncoMatch/Clinical Trials/NCT05453396
Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
Is NCT05453396 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Loncastuximab Tesirine for post-transplant lymphoproliferative disorder.
Treatment: Loncastuximab Tesirine — This phase II trial tests whether loncastuximab tesirine works to shrink tumors in patients with B-cell malignancies that have come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, called loncastuximab, linked to a chemotherapy drug, called tesirine. Loncastuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 positive
Group 1: CD19+ relapsed/refractory post-transplant lymphoproliferative disorder (PTLD)
Required: CD19 positive
Group 2: Relapsed/refractory. CD19+ B-cell non-Hodgkin lymphoma (B-NHL) excluding Waldenstrom's macroglobulinemia and marginal zone lymphoma
Required: CD19 positive
Group 3: CD19+ diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL) relapsing after chimeric antigen receptor (CAR) T-cell therapy or allogeneic transplant
Required: CD19 negative (minimal to absent expression by both immunohistochemistry and flow cytometry) (minimal to absent)
Group 4: Relapsed/refractory, CD19-negative B-NHL by both immunohistochemistry and flow cytometry (minimal to absent expression)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received:
at least 1 prior therapy
Must have received: CAR-T cell therapy
relapsing after chimeric antigen receptor (CAR) T-cell therapy
Must have received: allogeneic transplant
relapsing after ... allogeneic transplant
Cannot have received: (loncastuximab tesirine)
Previous treatment with loncastuximab tesirine
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^3/uL (off growth factors at least 72 hours), unless due to marrow involvement by lymphoma in which case ANC must be ≥ 0.5 x 10^3/uL; Platelet count ≥ 75 x 10^3/uL without transfusion in the prior 7 days, unless due to disease including splenomegaly in which case platelet count must be ≥ 50 x 10^3/uL
Kidney function
Blood creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 50 mL/min by Cockcroft and Gault equation
Liver function
ALT, AST, and GGT ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if Gilbert's syndrome)
ANC ≥ 1.0 x 10^3/uL (off growth factors at least 72 hours), unless due to marrow involvement by lymphoma in which case ANC must be ≥ 0.5 x 10^3/uL; Platelet count ≥ 75 x 10^3/uL without transfusion in the prior 7 days, unless due to disease including splenomegaly in which case platelet count must be ≥ 50 x 10^3/uL; ALT, AST, and GGT ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if Gilbert's syndrome); Blood creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 50 mL/min by Cockcroft and Gault equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05453396 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
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 qualify