This study is to evaluate the safety and pharmacokinetics of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms

A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms - Mature B-cell Neoplasms: Phase 1 Study of Epcoritamab in Pediatric Patients

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004555-16-ES

Enrollment

Registered

2021-12-16

Start date

2022-04-25

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/refractory Burkitt's or Burkitt-like lymphoma/leukemia, Diffuse large B-cell lymphoma , or other aggressive mature (CD20+) B-cell lymphomas MedDRA version: 20.0 Level: HLT Classification code 10006596 Term: Burkitt's lymphomas System Organ Class: 100000004851 MedDRA version: 21.0 Level: PT Classification code 10003903 Term: B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Class

Interventions

Product Name: Epcoritamab Product Code: ABBV-GMAB-3013 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Epcoritamab CAS Number: 2134641-34-0 Current Sponsor code: ABBV-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects = 1 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known CNS involvement by lymphoma at screening as confirmed by screening MRI/CT/PET brain scans (patients with evidence of CNS disease only in the CSF will be eligible). 2. Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents. 3. Other malignancy requiring therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of the study are to evaluate the safety and Pharmacokinetic profile of epcoritamab monotherapy in pediatric patients (and young adults) with relapsed/refractory Burkitt's or Burkitt-like lymphoma/leukemia, DLBCL, or other aggressive mature (CD20+) B-cell lymphomas who have failed to reach remission with re-induction therapy or who are unable to receive further consolidation with cell therapy.;Secondary Objective: The secondary objective of the study is to evaluate the preliminary efficacy and immunogenicity of epcoritamab monotherapy.;Primary end point(s): The primary endpoints are safety and tolerability, including adverse events of special interest (AESIs) of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.;Timepoint(s) of evaluation of this end point: Safety and tolerability are evaluated throughout the study. Pharmacokinetic parameters are evaluated the following timepoint: • Cycle 1: Day 10, Day 15-17, Day 19, Day 22 •Cycle 2: Day 1, Day 8-10, Day 12, Day 15 •Cycle 3-10: Day 1	—

Measure

Time frame

Main Objective: The primary objectives of the study are to evaluate the safety and Pharmacokinetic profile of epcoritamab monotherapy in pediatric patients (and young adults) with relapsed/refractory Burkitt's or Burkitt-like lymphoma/leukemia, DLBCL, or other aggressive mature (CD20+) B-cell lymphomas who have failed to reach remission with re-induction therapy or who are unable to receive further consolidation with cell therapy.;Secondary Objective: The secondary objective of the study is to evaluate the preliminary efficacy and immunogenicity of epcoritamab monotherapy.;Primary end point(s): The primary endpoints are safety and tolerability, including adverse events of special interest (AESIs) of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.;Timepoint(s) of evaluation of this end point: Safety and tolerability are evaluated throughout the study. Pharmacokinetic parameters are evaluated the following timepoint: • Cycle 1: Day 10, Day 15-17, Day 19, Day 22 •Cycle 2: Day 1, Day 8-10, Day 12, Day 15 •Cycle 3-10: Day 1

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Secondary

Measure	Time frame
Secondary end point(s): •Complete response rate (CR) per the International Pediatric Non- Hodgkin Lymphoma Response Criteria •Event free survival (EFS) •Overall survival (OS) •Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy •Overall Response (OR) •Duration of response (DOR) •Duration of complete response (DOCR) •Immunogenicity (antidrug antibody [ADA] and neutralizing anti-drug antibodies [nAb]);Timepoint(s) of evaluation of this end point: Disease evaluation (CT/MRI/PET) will be performed for all patients prior to administration of epcoritamab on Day 1 and at the following time points relative to Day 1: W6, W12, W24, W36, W48, 18 months, and 24 months, as well as prior to initiation of subsequent therapy, and as clinically indicated. Patients who do not attain a CR during therapy with epcoritamab will have additional disease assessments at W18, W30, W42, and every 3 months thereafter. Patients will be followed for a minimum of 3 years after enrollment.	—

Measure

Time frame

Secondary end point(s): •Complete response rate (CR) per the International Pediatric Non- Hodgkin Lymphoma Response Criteria •Event free survival (EFS) •Overall survival (OS) •Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy •Overall Response (OR) •Duration of response (DOR) •Duration of complete response (DOCR) •Immunogenicity (antidrug antibody [ADA] and neutralizing anti-drug antibodies [nAb]);Timepoint(s) of evaluation of this end point: Disease evaluation (CT/MRI/PET) will be performed for all patients prior to administration of epcoritamab on Day 1 and at the following time points relative to Day 1: W6, W12, W24, W36, W48, 18 months, and 24 months, as well as prior to initiation of subsequent therapy, and as clinically indicated. Patients who do not attain a CR during therapy with epcoritamab will have additional disease assessments at W18, W30, W42, and every 3 months thereafter. Patients will be followed for a minimum of 3 years after enrollment.

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Countries

Australia, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Trials Helpdesk

AbbVie Ltd

abbvie_reec@abbvie.com+34901200103

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026