Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

Non-hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206357
• Other study ID #: M20-429
• Secondary ID: 2021-004555-16
• Status: Recruiting
• Phase: Phase 1
• Start date: October 4, 2022
• Est. completion date: November 27, 2028

Study information

• Verified date: June 2024
• Source: Genmab
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally.

Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 27, 2028
• Est. primary completion date: June 18, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 25 Years

Eligibility

Inclusion Criteria:

• Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.

• Disease pathologically confirmed (tumor tissue) by local testing.

• Relapsed or primary refractory disease meeting any of the following criteria:

• Progressive disease at any time during second-line chemoimmunotherapy (CIT).

• Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.

• Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.

• Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.

• Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.

• Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.

• Recovery from toxic effects of prior chemoimmunotherapy.

• Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .

• Adequate bone marrow, hepatic, and renal function.

Exclusion Criteria:

• Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).

• Other malignancy requiring therapy.

• Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.

Related Conditions & MeSH terms

• Aggression
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Neoplasms
• Non-hodgkin Lymphoma

Intervention

Drug:
• Epcoritamab
Subcutaneous Injection (SC)

Locations

Country	Name	City	State
Australia	Perth Children's Hospital /ID# 240382	Nedlands	Western Australia
Australia	Royal Children's Hospital /ID# 240384	Parkville	Victoria
Australia	Children's Hospital at Westmead /ID# 240091	Westmead
Belgium	Universitair Ziekenhuis Leuven /ID# 242384	Leuven	Vlaams-Brabant
Canada	CHU Sainte-Justine /ID# 240766	Montreal	Quebec
Canada	Hospital for Sick Children /ID# 240767	Toronto	Ontario
Czechia	Fakultni nemocnice Brno /ID# 239956	Brno
Czechia	Duplicate_Fakultni Nemocnice v Motole /ID# 239957	Prague
France	CHU Bordeaux - Hopital Pellegrin /ID# 240832	Bordeaux	Gironde
France	Hospices Civils de Lyon /ID# 240834	Lyon
France	CHU de Nantes, Hotel Dieu -HME /ID# 240831	Nantes	Pays-de-la-Loire
France	Institut Gustave Roussy /ID# 240966	Villejuif Cedex	Val-de-Marne
Germany	Universitaetsklinikum Erlangen /ID# 240861	Erlangen	Bayern
Germany	Universitaetsklinikum Giessen und Marburg /ID# 240787	Marburg
Germany	Universitaetsklinikum Muenster /ID# 239970	Muenster	Nordrhein-Westfalen
Israel	Rambam Health Care Campus /ID# 240037	Haifa	H_efa
Israel	Schneider Children's Medical Center /ID# 240171	Petah Tikva	HaMerkaz
Israel	The Chaim Sheba Medical Center /ID# 240670	Ramat Gan	Tel-Aviv
Italy	Azienda Ospedaliero Universitaria Meyer /ID# 240049	Florence	Firenze
Italy	IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039	Rome	Roma
Japan	National Cancer Center Hospital /ID# 246722	Chuo-ku	Tokyo
Japan	Kyoto University Hospital /ID# 246907	Kyoto-shi	Kyoto
Japan	NHO Nagoya Medical Center /ID# 246680	Nagoya-shi	Aichi
Japan	Osaka City General Hospital /ID# 246906	Osaka-shi	Osaka
Japan	National Center for Child Health and Development /ID# 246658	Setagaya-ku	Tokyo
Korea, Republic of	Samsung Medical Center /ID# 239895	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 239894	Seoul
Spain	Hospital Universitario Vall d'Hebron /ID# 240715	Barcelona
Spain	Hospital Sant Joan de Deu /ID# 240719	Esplugues de Llobregat	Barcelona
Spain	Hospital Infantil Universitario Nino Jesus /ID# 240717	Madrid
Taiwan	National Taiwan University Hospital /ID# 242890	Taipei City
Turkey	Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026	Istanbul
United States	Levine Children's Hospital /ID# 242765	Charlotte	North Carolina
United States	Cincinnati Childrens Hospital Medical Center /ID# 239823	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center /ID# 240892	Dallas	Texas
United States	St Jude Children's Research Hospital /ID# 239184	Memphis	Tennessee
United States	Nicklaus Children's Hospital /ID# 241174	Miami	Florida
United States	Lucile Packard Children's Hospital /ID# 240854	Palo Alto	California
United States	Children's Hospital of Philadelphia - Main /ID# 239294	Philadelphia	Pennsylvania
United States	New York Medical College /ID# 239208	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
Genmab	AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AE)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 3 Years
Primary	Maximum Observed Concentration (Cmax)	Maximum observed concentration.	Up to Approximately Week 37
Primary	Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)	AUC from time 0 to time of last measurable concentration within the dosing interval.	Up to Approximately Week 37
Secondary	Percentage of Participants who Achieve Complete Response (CR)	CR is defined per the International Pediatric Non-Hodgkin Lymphoma Response Criteria as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically (morphologically) negative for disease (detection of disease with more sensitive techniques); bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease (detection of disease with more sensitive techniques).	Up to Approximately 1 Year
Secondary	Number of Participants with Event-free survival (EFS)	EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.	Up to Approximately 3 Years
Secondary	Number of Participants who Achieve Overall Survival (OS)	OS will be defined as the number of days from screening to the date of death from any cause.	Up to Approximately 3 Years
Secondary	Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy	Rate of initiation of stem cell transplantation or CAR-T therapy.	Up to Approximately 1 Year
Secondary	Percentage of Participants Achieving Overall Response (OR)	OR is assessed as the percentage of participants with an overall response.	Up to Approximately 1 Year
Secondary	Duration of response (DOR)	DOR is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause, whichever comes first.	Up to Approximately 1 Year
Secondary	Duration of CR (DOCR)	DOCR is defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first.	Up to Approximately 1 Year
Secondary	Percentage of Participants Achieving Immunogenicity	Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).	Up to Approximately Week 37