Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06919939
Phase
PHASE2
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma
  • Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    Epcoritamab will be administered via subcutaneous injection at the following dose levels and schedule over a total of twelve cycles: * Cycle 1 Day 1: Step-up dose of 0.16 mg * Cycle 1 Day 8: Step-up dose of 0.80 mg * Cycle 1 Day 15: First full dose of 48 mg. * Cycles 2 through 4 Days 1, 8 and 15: 48 mg * Cycles 5 through 12 Days 1 and 15: 48 mg
  • Loncastuximab Tesirine — DRUG
    Loncastuximab will be administered intravenously (IV) at the following dose level and schedule over a total of four cycles: * Cycles 1 and 2 Day 1: 120 mcg/kg * Cycles 3 and 4 Day 1: 75 mcg/kg * Cycle 4 Day 22: 75 mcg/kg

Study Details

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.

Key Dates

Start date
Jan 7, 2026
Status verified
Feb 2026
Primary completion
Jan 7, 2031
Completion
Jan 7, 2031

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EPCOR in combination with LONCA Treatment Group
    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.

Primary Outcome Measure

Number of Participants Experiencing Cytokine Release Syndrome (CRS)-related Toxicity after Epcoritamab Administration [ Time Frame: Up to 14 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Juan Alderuccio, MD
[email protected]
305-243-4372
Juan Alderuccio, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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