This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma

Phase 1

• Conditions: B-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphoma; MedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-005725-24-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-04
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Adult male or female, at least 18 years old
2. Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to WHO 2016 classification and documented in pathology report:
•DLBCL, not otherwise specified (NOS)
•High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 (double-hit” or triple-hit”)
Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible
•Follicular lymphoma Grade 3B
3. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2
4. Subject must have 1 or more measurable disease sites:
•A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s)
AND
•At least 1 measurable nodal lesion (long axis = 1.5cm and short axis > 1.0 cm) or = 1 measurable extra-nodal lesion (long axis = 1.0 cm) on CT scan or MRI
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

1.Diagnosis of High-grade B-cell lymphomas NOs or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL)
2. Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified