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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG, AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

20 May 2022 → 9 May 2026

Decision date (initial)

2023-12-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2023-504795-20-00

EudraCT number

2021-004555-16

ClinicalTrials.gov

NCT05206357

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

The primary objectives of the study are to evaluate the safety and PK 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 objectives 1

1. The secondary objective of the study is to evaluate the preliminary efficacy and immunogenicity of epcoritamab monotherapy.

Conditions and MedDRA coding

Relapsed/Refractory Aggressive Mature B-cell Neoplasms

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002907-PIP01-02

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Subjects or their legally authorized representative, if permitted, must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. For those subjects who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide written informed consent and subject willing and able to give assent, as appropriate for age and country. Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator's discretion should be applied.
2. Male or female subjects, ≥ 1 and < 18 years old at the time of primary diagnosis. - Subjects up to 25 years old with diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
3. Subject must be able to tolerate subcutaneous injections.
4. Disease pathologically confirmed (tumor tissue) by local testing.
5. 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.
6. Recovery from toxic effects of prior chemoimmunotherapy.
7. 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 .
8. Adequate bone marrow, hepatic, and renal function.

Exclusion criteria 3

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoints are safety and tolerability, including AESIs of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.

Secondary endpoints 8

1. CR per the International Pediatric Non-Hodgkin Lymphoma Response Criteria
2. Event-free survival (EFS)
3. Overall survival (OS)
4. Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy
5. Overall response (OR)
6. Duration of response (DOR)
7. Duration of CR (DOCR)
8. Immunogenicity ([ADA] and neutralizing anti-drug antibodies (nAb))

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinial Trial Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinial Trial Helpdesk

Third parties 8

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinial Trial Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinial Trial Helpdesk

Sponsor responsibilities

Article 77 compliance

AbbVie Deutschland GmbH & Co. KG

Contact point sponsor

AbbVie Deutschland GmbH & Co. KG

Article 77 implementation

AbbVie Deutschland GmbH & Co. KG

Locations

6 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

6 submissions — initial application plus substantial / non-substantial modifications