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-DE
• 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: 2022-09-16
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

1. Adult male or female, at least 18 years old
2. (Arms 1, 2, 3 and 4) Diagnosis of diffuse large B-cell lymphoma (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 World Health Organization (WHO) 2016 classification and documented in pathology report:
•DLBCL
•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 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 374
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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