RecruitingPhase 2NCT06905509

Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma

A Phase 2 Study of Epcoritamab (Epco) Plus Physician's Choice of Platinum-Containing Chemotherapy Pre-Autologous Hematopoietic Cell Transplantation (AutoHCT) Followed by Post-AutoHCT Epco Consolidation/ Maintenance in Relapsed/ Refractory Large B-Cell Lymphoma (R/R LBCL)


Sponsor

Joseph Tuscano

Enrollment

25 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding epcoritamab (a bispecific antibody that helps the immune system attack lymphoma cells) to standard platinum-based chemotherapy before stem cell transplant improves outcomes in people with large B-cell lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with relapsed or refractory large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma, or transformed follicular/marginal zone lymphoma) - Your tumor has tested positive for the CD20 protein - Your cancer came back or did not fully respond to first-line chemotherapy - You are a candidate for high-dose chemotherapy and autologous stem cell transplant **You may NOT be eligible if...** - You have certain serious infections (e.g., uncontrolled HIV or hepatitis) - You have had prior CAR-T cell therapy or other bispecific antibody treatment - You have significant heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutologous Hematopoietic Stem Cell Transplantation

Undergo autoHCT

DRUGCarboplatin

Given carboplatin

DRUGCytarabine

Given cytarabine

DRUGDexamethasone

Given dexamethasone

BIOLOGICALEpcoritamab

Given SC

DRUGEtoposide Phosphate

Given etoposide phosphate

DRUGGemcitabine

Given gemcitabine

DRUGIfosfamide

Given ifosfamide

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGOxaliplatin

Given oxaliplatin

BIOLOGICALRituximab

Given rituximab


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT06905509


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