None listed
Conditions
Interventions
Drug : A single 28-day cycle of bridging therapy is administered prior to tisagenlecleucel infusion
Epcoritamab (subcutaneous):
Cycle 1 Day 1: 0.16 mg (Priming Dose) Cycle 1 Day 8: 0.8 mg (Inter
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, age =19 years at the time of signing the informed consent form. 2. Histologically confirmed Diffuse Large B-cell Lymphoma (DLBCL), including: o DLBCL, Not Otherwise Specified (NOS). o DLBCL transformed from follicular lymphoma. o High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 rearrangements. 3. Relapsed or refractory disease after two or more prior lines of systemic therapy. 4. Eligible for treatment with commercial tisagenlecleucel, and is scheduled for leukapheresis. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. At least one measurable lesion according to the Lugano classification. 7. Life expectancy of =12 weeks. 8. Adequate bone marrow function defined as: o Absolute neutrophil count (ANC) =1.0×109/L. o Platelet count =75×109/L (or =50×109/L in the presence of bone marrow involvement). o Hemoglobin =8.0 g/dL (may be maintained by transfusion). 9. Adequate organ function defined as: o Total bilirubin level =1.5× ULN (unless due to Gilbert's syndrome or lymphoma involvement). o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3.0× ULN (or =5× ULN if due to hepatic involvement of disease). o Estimated creatinine clearance =40 mL/min, as calculated by the Cockcroft-Gault formula. 10. Voluntarily agrees to participate by giving written informed consent and is able to comply with all required study procedures.
Exclusion criteria
Exclusion criteria: 1. History of primary central nervous system (CNS) lymphoma or known active CNS involvement by lymphoma. 2. Prior exposure to CD3xCD20 bi-specifics 3. Contraindications to tisagenlecleucel therapy. 4. Known history of severe allergic or anaphylactic reactions to any component of epcoritamab or the planned chemotherapy backbone (GemOx or ICE). 5. Known active bacterial, viral, fungal, mycobacterial, or other infection. 6. Clinically significant cardiovascular disease, including myocardial infarction or stroke within 6 months, unstable angina within 3 months, or New York Heart Association (NYHA) Class III-IV congestive heart failure. 7. Left ventricular ejection fraction (LVEF) <50%. 8. History of autoimmune disease requiring immunosuppressive therapy, with the exception of up to 20 mg prednisone daily or equivalent. 9. Current seizure disorder requiring therapy within the past 12 months. 10. Major surgery within 4 weeks prior to randomization. 11. Prior history of allogeneic hematopoietic stem cell transplantation 12. Vaccination with live vaccines within 28 days prior to randomization. 13. Pregnant or breastfeeding females, or subjects (male or female) of childbearing potential who are unwilling to use a highly effective method of contraception for the duration of the study and for at least 6 months(ICE arm) or 15 months(GemOx arm) after the last dose of study drug. 14. Concurrent treatment with another investigational drug or participation in another therapeutic clinical study within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug. 15. Any other life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The corresponding primary endpoint is the Overall Response Rate to bridging therapy, defined as the proportion of patients achieving a complete or partial response, assessed per Lugano 2014 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate, Complete Response, and Partial Response at 3 months and 6 months post-CAR-T. ;Changes in peripheral immune cell, CAR-gene copies, and cytokine profiles. ;Progression-Free Survival. ;Overall Survival . ;Incidence and severity of Adverse Events. ;Modulation of the tumor microenvironment via spatial transcriptomics. ;Minimal Residual Disease kinetics in plasma. | — |
Countries
Korea, Republic of
Contacts
Public ContactNa Eun Lee
Asan Medical Center
Outcome results
None listed