Epcoritamab for PTLD

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Timothy Voorhees

Must not be taking: Steroids, Anti-epileptics

Disqualifiers: CNS involvement, Uncontrolled infection, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase Ib trial tests the safety and effectiveness of epcoritamab in treating patients with post-transplant lymphoproliferative disorder (PTLD) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, 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. Giving epcoritamab may be safe and effective in treating patients with relapsed or refractory B-cell PTLD.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that any investigational treatments must be completed at least 4 weeks before starting the study treatment. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Epcoritamab for treating PTLD?

While there is no direct data on Epcoritamab for PTLD, similar treatments like rituximab, which also targets CD20-positive cells, have shown increased survival rates in PTLD patients. This suggests that Epcoritamab, which works in a similar way, might also be effective. ^{1 2 3 4 5}

Research Team

Timothy J. Voorhees, MD, MSCR

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with PTLD, a type of lymphoma that occurs after organ transplant and has either returned or didn't respond to prior treatments. Participants must have measurable disease and be able to undergo procedures like biopsies and scans.

Inclusion Criteria

My condition did not improve after reducing my immune-suppressing medication.

My condition did not improve after treatment with rituximab alone or with chemotherapy.

My cancer can be measured and is larger than 1.5 cm or is in my bone marrow.

Exclusion Criteria

Pregnant or breastfeeding

Electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant

I do not have any active infections, or if I do, they are under control.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive epcoritamab subcutaneously on days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 4-9, and day 1 of each subsequent cycle. Cycles repeat every 28 days for up to 12 cycles.

Up to 12 cycles (28 days each)

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 28 days and then every 3 months for up to 3 years.

Up to 3 years

Follow-up visits every 3 months

Treatment Details

Interventions

• Epcoritamab (Monoclonal Antibodies)

Trial Overview The trial is testing epcoritamab's safety and effectiveness in treating relapsed/refractory B-cell PTLD. Epcoritamab is a bispecific antibody targeting proteins on T cells and some lymphoma cells, potentially helping the immune system destroy cancer.

Participant Groups

Group I: Treatment (epcoritamab) Experimental Treatment 5 Interventions

Patients receive epcoritamab SC on days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 4-9, and day 1 of each subsequent cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR may continue to receive epcoritamab if disease progression occurs within 6 months. Patients with PR or SD continue to receive epcoritamab in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT and blood sample collection throughout the study and may undergo biopsy during screening.

Who Is Running the Clinical Trial?

Timothy Voorhees

Lead Sponsor

Trials

3

Recruited

70+

Genmab

Industry Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In the Phase II PTLD-2 trial involving 60 adult solid organ transplant recipients with CD20-positive PTLD, rituximab monotherapy was effective, achieving a 94% overall response rate, with a 2-year overall survival rate of 100% in the low-risk group.

The study demonstrated that low-risk patients had a 66% event-free survival rate after treatment with rituximab alone, which was comparable to historical controls, while treatment intensification for very-high-risk patients did not yield improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial. Zimmermann, H., Koenecke, C., Dreyling, MH., et al.[2022]

In a study of 24 patients with post-transplant lymphoproliferative disorder (PTLD), rituximab treatment was associated with a significant increase in overall survival, with a median survival of 64 months compared to just 1-30 months for those not treated with rituximab.

The overall response rate to treatment was 62%, with rituximab showing a higher response rate of 66% compared to 50% for non-rituximab treatments, suggesting that rituximab should be considered as a first-line therapy for PTLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line use of rituximab correlates with increased overall survival in late post-transplant lymphoproliferative disorders: retrospective, single-centre study. Martínez-Calle, N., Alfonso, A., Rifón, J., et al.[2017]

In a retrospective analysis of 26 adults with post-transplant lymphoproliferative disorder (PTLD), standard CHOP chemotherapy showed a 65% overall response rate, indicating its potential effectiveness in treating this condition.

The median overall survival was 13.9 months and the median progression-free survival was 42 months, providing important survival data for patients with PTLD who do not respond to reduced immunosuppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHOP-21 for the treatment of post-transplant lymphoproliferative disorders (PTLD) following solid organ transplantation. Choquet, S., Trappe, R., Leblond, V., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

First-line use of rituximab correlates with increased overall survival in late post-transplant lymphoproliferative disorders: retrospective, single-centre study. [2017]

3. Italy pubmed.ncbi.nlm.nih.gov

CHOP-21 for the treatment of post-transplant lymphoproliferative disorders (PTLD) following solid organ transplantation. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Humanized anti-CD20 monoclonal antibody (Rituximab) treatment for post-transplant lymphoproliferative disorder. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

EBV and posttransplantation lymphoproliferative disease: what to do? [2022]