Actively Recruiting
Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
Led by Joseph Tuscano · Updated on 2025-09-29
25
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
J
Joseph Tuscano
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide \[RICE\], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP/X\] or gemcitabine and oxaliplatin \[Gem/Ox\]) and autologous hematopoietic cell transplant (HCT) works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab, a type of bispecific T-cell engager, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs, such as ifosfamide, etoposide phosphate, cytarabine, and gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. An autologous HCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving epcoritamab in combination with SOC platinum-based chemotherapy, such as RICE, RDHAP/X and Gem/Ox, and autologous HCT may kill more cancer cells in patients with relapsed or refractory LBCL.
CONDITIONS
Official Title
Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or nodal marginal zone lymphoma
- Disease relapsed or refractory after standard frontline chemotherapy
- At least one prior line of systemic therapy for large cell lymphoma
- Eligible for platinum-containing chemotherapy and autologous hematopoietic cell transplantation
- Eastern Cooperative Oncology Group performance status 0 to 2
- Measurable disease with at least one lymph node >1.5 cm or extranodal lesion >1 cm
- Age 18 years or older
- Creatinine clearance of 45 mL/min or higher
- Liver enzymes (ALT, AST) not exceeding 3 times the upper limit of normal
- Bilirubin ≤1.5 times upper limit of normal (or higher if due to Gilbert's syndrome or controlled autoimmune hemolytic anemia)
- Hemoglobin ≥8.0 g/dL
- Absolute neutrophil count ≥1000/uL
- Platelet count ≥75,000/uL (or ≥50,000/uL if bone marrow involvement or splenomegaly)
- Normal coagulation tests (PT/INR/aPTT ≤1.5 times upper limit of normal)
- No evidence of myelodysplastic syndrome or hypoplastic bone marrow if cytopenias present
- HIV-infected patients must have stable viral load and CD4 count on effective therapy
- Patients with prior hepatitis B or C infection must meet specific viral load and treatment criteria
- Women of child-bearing potential and men must agree to use contraception
- Signed informed consent form
You will not qualify if you...
- Unresolved adverse events from prior lymphoma therapy above grade 1, except alopecia and minor lab abnormalities
- Uncontrolled illness or infection
- Active central nervous system lymphoma involvement (unless complete response achieved and confirmed)
- Receiving other investigational treatments
- Prior treatment with bispecific T-cell engagers
- Recent investigational drug use within 4 weeks or 5 half-lives
- Concurrent anti-cancer treatments except certain hormonal therapies
- Grade 2 or higher motor or sensory neuropathy
- History of other malignancies unless adequately treated and disease-free for 3 years
- Active infections requiring systemic treatment
- Autoimmune diseases requiring immunosuppression above low-dose steroids
- Pregnant or breastfeeding
- Prior allogeneic stem cell or solid organ transplantation
- Significant cardiac disease or recent cardiovascular events
- Recent live vaccine administration
- Immune effector cell encephalopathy score below 10
- Allergies or intolerance to epcoritamab or anti-CD20 antibodies
- Active hepatitis B, hepatitis C, HIV, or cytomegalovirus infection
- Planning pregnancy or sperm donation during or within 12 months after study
- Active or inadequately treated latent tuberculosis
- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
S
Selina Laqui
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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