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

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.

Conditions

• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
• Recurrent High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements
• Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
• Recurrent Nodal Marginal Zone Lymphoma
• Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
• Refractory High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements
• Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
• Refractory Nodal Marginal Zone Lymphoma
• Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autoHCT

DRUG

Carboplatin

Given carboplatin

DRUG

Cytarabine

Given cytarabine

DRUG

Dexamethasone

Given dexamethasone

BIOLOGICAL

Epcoritamab

Given SC

DRUG

Etoposide Phosphate

Given etoposide phosphate

DRUG

Gemcitabine

Given gemcitabine

DRUG

Ifosfamide

Given ifosfamide

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Oxaliplatin

Given oxaliplatin

BIOLOGICAL

Rituximab

Given rituximab

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Joseph Tuscano

  lead OTHER

Principal Investigators

• Joseph M Tuscano · University of California, Davis

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-31

Primary Completion

2028-07-01

Completion

2030-08-01

FDA Drug

Yes

Countries

• United States

Study Locations