26 Participants Needed

Epcoritamab + Loncastuximab Tesirine for B-Cell Lymphoma

(EPCOR+LONCA Trial)

JA
Overseen ByJuan Alderuccio, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Miami
Must be taking: Anti-CD20, Anthracyclines
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on glucocorticoid treatment, it must be reduced to a maximum of 25 mg daily in the last 14 days before starting the trial.

What data supports the effectiveness of the drug combination Epcoritamab and Loncastuximab Tesirine for B-Cell Lymphoma?

Epcoritamab has shown strong anti-tumor activity in B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), by engaging T-cells to attack cancer cells. Loncastuximab Tesirine has demonstrated effectiveness in treating relapsed or refractory DLBCL, with a notable response rate in clinical trials. Both drugs have been individually effective in similar conditions, suggesting potential when combined.12345

Is the combination of Epcoritamab and Loncastuximab Tesirine safe for humans?

Loncastuximab Tesirine has been shown to have an acceptable safety profile in clinical trials for B-cell non-Hodgkin lymphoma, with common side effects including low blood cell counts, fatigue, nausea, and liver enzyme changes. Epcoritamab has also demonstrated safety in early trials for B-cell lymphoma, but specific safety data for the combination of these two drugs is not available.12467

What makes the drug combination of Epcoritamab and Loncastuximab Tesirine unique for treating B-cell lymphoma?

This drug combination is unique because Epcoritamab is a bispecific antibody that engages T-cells to target and kill cancerous B-cells, while Loncastuximab Tesirine is an antibody-drug conjugate that delivers a toxic payload directly to B-cells. Together, they offer a novel approach by combining two different mechanisms to attack B-cell lymphoma.12348

What is the purpose of this trial?

The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body.

Research Team

JA

Juan Alderuccio, MD

Principal Investigator

University of Miami

Eligibility Criteria

Adults with relapsed/refractory large B-cell lymphoma who've had at least one prior treatment including anti-CD20 antibody and anthracycline. They must have a life expectancy of 12 weeks, manageable health status (ECOG PS 0-2), and adequate organ function. HIV-positive patients can join under certain conditions. Exclusions include CNS lymphoma involvement, pregnancy, severe chronic diseases, recent major surgery complications, active hepatitis B or C infection, previous CAR-T therapy or stem cell transplant.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.
Patients with history of human immunodeficiency virus (HIV) are eligible under specific conditions
Ability to comply with the trial protocol
See 8 more

Exclusion Criteria

My lymphoma affects my brain or spinal cord.
Pregnant or breast feeding
I do not have severe lung disease or other serious conditions that could affect my treatment.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 4 cycles of combination EPCOR and LONCA therapy, followed by an additional 8 cycles of EPCOR therapy

12 months
Cycles 1-3: 21 days each, Cycles 4-12: 28 days each

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

36 months

Treatment Details

Interventions

  • Epcoritamab
  • Loncastuximab Tesirine
Trial Overview The trial is testing the combination of two drugs: Epcoritamab and Loncastuximab Tesirine for treating large B-cell lymphoma that has returned after treatment or hasn't responded to it. The goal is to see if this drug duo can safely reduce or eliminate cancer cells in participants.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EPCOR in combination with LONCA Treatment GroupExperimental Treatment2 Interventions
Participants in the Epcoritamab (EPCOR) in combination with Loncastuximab (LONCA) treatment group will receive up to 4 cycles of combination EPCOR and LONCA therapy, and an additional 8 cycles of EPCOR therapy, for a total of twelve treatment cycles. Cycles 1 through 3 last 21 days each; cycles four through 12 last 28 days each. Protocol therapy will last approximately 12 months. Total participation duration is approximately 3 years.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

ADC Therapeutics S.A.

Industry Sponsor

Trials
32
Recruited
2,700+

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

Findings from Research

Epcoritamab, a bispecific antibody targeting CD3 and CD20, showed a 63.1% overall response rate in 157 patients with relapsed or refractory large B-cell lymphoma, indicating its efficacy in this challenging patient population.
The treatment was generally well-tolerated, with manageable side effects; however, cytokine release syndrome was common (49.7%), and there was one reported fatality due to immune effector cell-associated neurotoxicity syndrome.
Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial.Thieblemont, C., Phillips, T., Ghesquieres, H., et al.[2023]
In a phase 2 trial involving 145 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), loncastuximab tesirine demonstrated a significant overall response rate of 48.3%, indicating its effectiveness as a treatment option for this challenging patient population.
The treatment was associated with an acceptable safety profile, with serious adverse events occurring in 39% of patients, but none were directly linked to loncastuximab tesirine, suggesting it may be a safe option for heavily pretreated patients.
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial.Caimi, PF., Ai, W., Alderuccio, JP., et al.[2021]
Epcoritamab is a bispecific antibody that targets CD3 and CD20, designed for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and received conditional approval in the USA on May 19, 2023, for adult patients after at least two prior therapies.
The drug has also received a positive opinion in the EU and is under review in Japan, indicating its potential as a significant treatment option for patients with difficult-to-treat B-cell non-Hodgkin lymphoma subtypes.
Epcoritamab: First Approval.Frampton, JE.[2023]

References

Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. [2023]
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. [2021]
Epcoritamab: First Approval. [2023]
Loncastuximab tesirine for diffuse large B-cell lymphoma. [2021]
Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment. [2021]
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma: a review of clinical data. [2022]
Final results of a phase 1 study of loncastuximab tesirine in relapsed/refractory B-cell non-Hodgkin lymphoma. [2022]
Loncastuximab Tesirine: First Approval. [2021]
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