Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged 18 years or older at the time of signing informed consent.
Able and willing to sign the informed consent form (ICF).
Ability to comply with the trial protocol.
LBCL or DLBCL, not otherwise specified (NOS)
Disqualifiers
Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.
Prior treatment with anti-cluster of differentiation 19 (anti-CD19) chimeric antigen receptor T-cell (CAR-T) therapy
Prior exposure to bispecific T-cell engaging antiCD20XCD3 antibodies
Prior autologous or allogenic stem cell transplant
Trial design
Design model
Single group
Treatments tested in this trial
Epcoritamab
DrugEpcoritamab 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
DrugLoncastuximab 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
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: EPCOR in combination with LONCA Treatment GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants Experiencing Cytokine Release Syndrome (CRS)-related Toxicity after Epcoritamab Administration
The number of participants experiencing Cytokine Release Syndrome (CRS) toxicity associated with Epcoritamab therapy will be reported, including Grades 2, 3 and 4. CRS-related toxicity will be assessed according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Time frame
Up to 14 months2
Number of Participants Experiencing Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)-related Toxicity
The number of participants experiencing Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)-related toxicity including Grades 2, 3 and 4. ICANS-related toxicity will be assessed according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Time frame
Up to 14 months3
Number of Participants Experiencing Neurologic Toxicities Associated with Epcoritamab
The number of participants experiencing neurologic toxicities associated with Epcoritamab therapy will be reported, including Grades 2, 3 and 4. Neurologic toxicities will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Time frame
Up to 14 months4
Number of Participants Experiencing Fluid Accumulation Associated with Loncastuximab
The number of participants experiencing fluid accumulation associated with Loncastuximab therapy will be reported, including Grades 2, 3 and 4. Fluid accumulation toxicities will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Time frame
Up to 31 weeksSecondary outcomes
1
Overall Response Rate (ORR)
Overall response rate is defined as the number of participants with complete metabolic response (CMR) or partial metabolic response (PMR) as the best response. Response will be assessed according to Lugano 2014 criteria.
Time frame
Up to 36 months2
Partial Metabolic Response (PMR) Rate
PMR rate is defined as the number of participants with partial metabolic response (PMR) as the best response according to Lugano 2014 criteria.
Time frame
Up to 36 months3
Progression-Free Survival (PFS)
PFS is defined as the elapsed time in months from the start of treatment until disease progression or death, whichever is earlier. Participants who remain alive without progression will be censored at the last documented disease assessment date. Response will assessed according to Lugano 2014 criteria.
Time frame
Up to 36 months4
Overall Survival (OS)
OS is defined as the elapsed time in months from the start of treatment until death from any cause. Alive participants will be censored at the last date known to be alive.
Time frame
Up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov