Diffuse Large B-cell Lymphoma
Conditions
Interventions
Experimental group:Loncastuximab tesirine intravenous injection
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Male or female patients aged 18 years or older who are current residents of mainland China with Chinese ancestry 2. Pathologic diagnosis of DLBCL, as defined by the 2016 WHO classification, to include: DLBCL not otherwise specified, DLBCL transformed from indolent lymphoma, and high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements 3. Relapsed or refractory disease following two or more multi-agent systemic treatment regimens 4. Patients who have received previous CD19-directed therapy must have a biopsy that shows CD19 protein expression after completion of the CD19-directed therapy 5. Measurable disease as defined by the 2014 Lugano Classification 6. ECOG performance status 0-2 7. Adequate organ function 8. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a condom from the time of the first dose until at least 7 months after the patient receives his last dose of loncastuximab tesirine
Exclusion criteria
Exclusion criteria: 1. Previous treatment with loncastuximab tesirine 2. Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody 3. Pathologic diagnosis of Burkitt lymphoma 4. Bulky disease, defined as any tumor = 10 cm in longest dimension 5. Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary 6. Autologous stem cell transplant within 30 days prior to start of study drug (C1D1) 7. Allogeneic stem cell transplant within 60 days prior to start of study drug (C1D1) 8. Active graft-versus-host disease 9. Post-transplant lymphoproliferative disorders 10. Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease 11. Seropositive for human immunodeficiency virus (HIV), serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load, or hepatitis C virus 12. History of Stevens-Johnson syndrome or toxic epidermal necrolysis 13. Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease 14. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath) 15. Breastfeeding or pregnant 16. Significant medical comorbidities 17. Major surgery, radiotherapy, chemotherapy, or other antineoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor 18. Use of any other experimental medication within 14 days prior to start of study drug (C1D1) 19. Planned live vaccine administration after starting study drug (C1D1) 20. Failure to recover to Grade = 1 (CTCAE 4.0) from acute non-hematologic toxicity (except Grade = 2 neuropathy or alopecia) due to previous therapy prior to screening 21. Congenital long QT syndrome or a corrected QTcF interval of > 480 ms at screening (unless secondary to pacemaker or bundle branch block) 22. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at riskHIV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response (CR) Rate;Duration of response (DOR);Relapse-free survival (RFS);Progression-free survival (PFS);Overall survival (OS);Frequency and severity of adverse events (AEs) and serious adverse events (SAEs);Changes from baseline of safety laboratory values, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and 12-lead electrocardiograms (ECGs);Concentrations and PK parameters of loncastuximab tesirine total antibody, pyrrolobenzodiazepine (PBD)-conjugated antibody, and unconjugated warhead SG3199;Anti-drug antibody (ADA) titers and, if applicable, neutralizing activity to loncastuximab tesirine after treatment with loncastuximab tesirine; | — |
Countries
China
Contacts
Public ContactYuqin Song
Beijing Cancer Hospital
Outcome results
None listed