NCT03888105: ELM-2

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

Active, enrolled Phase 2 Last updated 15 October 2025

What this trial tests

Phase 2 trial testing Odronextamab in B-cell Non-Hodgkin Lymphoma (B-NHL) in 515 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 November 2019

Primary endpoint
6 July 2026

15 December 2028

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	515
Start date	13 November 2019
Primary completion	6 July 2026
Estimated completion	15 December 2028
Sites	119 locations across France, Italy, Japan, Taiwan, United Kingdom, Germany, Poland, South Korea

Drugs / interventions tested

• Odronextamab — full drug profile →

Conditions studied

• B-cell Non-Hodgkin Lymphoma (B-NHL) — all drugs for B-cell Non-Hodgkin Lymphoma (B-NHL) →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with B-cell Non-Hodgkin Lymphoma (B-NHL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).

The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.

The study is looking at several other research questions, including:

* To see if odronextamab works to destroy cancer cells
* Side effects that may be experienced by people taking odronextamab
* How odronextamab works in the body
* How much odronextamab is present in the blood

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2020.
   Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
2. Emerging new therapeutic antibody derivatives for cancer treatment.
   Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
3. Antibodies to watch in 2022.
   Kaplon H, Chenoweth A, Crescioli S, Reichert JM. · · 2022 · cited 245× · PMID 35030985 · DOI 10.1080/19420862.2021.2014296
4. Odronextamab, a human CD20×CD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial.
   Bannerji R, Arnason JE, Advani RH, Brown JR, et al · · 2022 · cited 208× · PMID 35366963 · DOI 10.1016/s2352-3026(22)00072-2
5. Antibodies to watch in 2023.
   Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410
6. Bispecific Antibodies: From Research to Clinical Application.
   Ma J, Mo Y, Tang M, Shen J, et al · · 2021 · cited 199× · PMID 34025638 · DOI 10.3389/fimmu.2021.626616
7. Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
   Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276
8. Antibodies to watch in 2024.
   Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450