NCT02651662: CLIO-1

A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies

Active, enrolled Phase 1 Last updated 2 February 2026

What this trial tests

Phase 1 trial testing cemiplimab in Relapsed/Refractory Aggressive B-Cell Lymphoma in 105 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 January 2016

Primary endpoint
31 May 2026

31 May 2026

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	11 January 2016
Primary completion	31 May 2026
Estimated completion	31 May 2026
Sites	30 locations across Austria, Israel, Germany, Poland, United States, Spain

Drugs / interventions tested

• cemiplimab (CEMIPLIMAB) — full drug profile →
• odronextamab — full drug profile →

Conditions studied

• Relapsed/Refractory Aggressive B-Cell Lymphoma — all drugs for Relapsed/Refractory Aggressive B-Cell Lymphoma →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Relapsed/Refractory Aggressive B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is researching a combination of 2 experimental drugs, referred to as "study drugs", called odronextamab (also known as REGN1979) and cemiplimab (also known as REGN2810). The study is focused on patients who have relapse/refractory aggressive B-cell lymphoma. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose regimen for the combination with odronextamab.

This study is also looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How effective the study drugs are against the disease
* How much study drug is in the blood at different times
* Whether the body makes substances or protein called antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)

Publications & conference data

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

1. Acute lymphoblastic leukemia: a comprehensive review and 2017 update.
   Terwilliger T, Abdul-Hay M. · · 2017 · cited 765× · PMID 28665419 · DOI 10.1038/bcj.2017.53
2. Research Status and Outlook of PD-1/PD-L1 Inhibitors for Cancer Therapy.
   Ai L, Chen J, Yan H, He Q, et al · · 2020 · cited 149× · PMID 32982171 · DOI 10.2147/dddt.s267433
3. A Mini-Review for Cancer Immunotherapy: Molecular Understanding of PD-1/PD-L1 Pathway & Translational Blockade of Immune Checkpoints.
   Li Y, Li F, Jiang F, Lv X, et al · · 2016 · cited 110× · PMID 27438833 · DOI 10.3390/ijms17071151
4. Advances in targeted therapy for malignant lymphoma.
   Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
5. Rationale for Combining Bispecific T Cell Activating Antibodies With Checkpoint Blockade for Cancer Therapy.
   Kobold S, Pantelyushin S, Rataj F, Vom Berg J. · · 2018 · cited 83× · PMID 30090763 · DOI 10.3389/fonc.2018.00285
6. Overcoming the challenges associated with CD3+ T-cell redirection in cancer.
   Singh A, Dees S, Grewal IS. · · 2021 · cited 82× · PMID 33469153 · DOI 10.1038/s41416-020-01225-5
7. Targets of Immune Escape Mechanisms in Cancer: Basis for Development and Evolution of Cancer Immune Checkpoint Inhibitors.
   Dutta S, Ganguly A, Chatterjee K, Spada S, et al · · 2023 · cited 81× · PMID 36829496 · DOI 10.3390/biology12020218
8. Biology drives the discovery of bispecific antibodies as innovative therapeutics.
   Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003