Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505347-38-00

Acronym

M22-132

Enrollment

Registered

2024-02-05

Start date

2022-06-13

Completion date

Unknown

Last updated

2025-11-21

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

Conditions

B-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphoma

Brief summary

The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.

Detailed description

Best overall response (BOR) by Lugano 2014 criteria as assessed by investigator for epcoritamab in combination with other antineoplastic agents., Antilymphoma activity of epcoritamab in combination with other antineoplastic agents: - Duration of response determined per Lugano 2014 criteria as assessed by investigator. - Progression free survival determined per Lugano 2014 criteria as assessed by investigator. - Complete response during the study determined per Lugano 2014 criteria as assessed by investigator. - Time to response determined per Lugano 2014 criteria as assessed by investigator. - Time to next antilymphoma therapy.

Interventions

DRUGPolivy 30 mg powder for concentrate for solution for infusion.

DRUGEpcoritamab (GEN3013)

DRUGTruxima 100 mg concentrate for solution for infusion

DRUGIMBRUVICA 140 mg hard capsules

DRUGGolcadomide

DRUGRevlimid 10 mg hard capsules

DRUGPIRTOBRUTINIB

DRUGCyclophosphamide Injection 500 mg.

DRUGVenetoclax

DRUGRevlimid 25 mg hard capsules

DRUGDecortin® H 20 mg Tabletten

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGDecortin® H 5 mg Tabletten

DRUGAdriblastin® 50 mg Stechampulle

DRUGRevlimid 20 mg hard capsules

DRUGRevlimid 5 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.	—

Secondary

Measure	Time frame
Best overall response (BOR) by Lugano 2014 criteria as assessed by investigator for epcoritamab in combination with other antineoplastic agents., Antilymphoma activity of epcoritamab in combination with other antineoplastic agents: - Duration of response determined per Lugano 2014 criteria as assessed by investigator. - Progression free survival determined per Lugano 2014 criteria as assessed by investigator. - Complete response during the study determined per Lugano 2014 criteria as assessed by investigator. - Time to response determined per Lugano 2014 criteria as assessed by investigator. - Time to next antilymphoma therapy.	—

Measure

Time frame

—

Countries

Czechia, Denmark, France, Germany, Hungary, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026