AzTrials
AzTrials

Relapsed/Refractory Aggressive B-Cell LymphomaPhase 1CLIO-1NCT02651662

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

A Phase 1 study testing cemiplimab and odronextamab in people with Relapsed/Refractory Aggressive B-Cell Lymphoma, run by Regeneron Pharmaceuticals at 30 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cemiplimab and odronextamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
30 sitesin 6 countries
Study dates
11 Jan 2016to 29 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have documented CD20+ aggressive B-cell NHL that is either not responsive to or relapsed after at least 2 prior lines of systemic therapy, for whom treatment with an anti-CD20 antibody may be appropriate. In addition, prior treatments should at least contain an anti-CD20 antibody and an alkylating agent.
  • Must have at least 1 nodal lesion (≥1.5 cm), or at least one extranodal lesion with longest transverse diameter (LDi) greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI]).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Adequate bone marrow and hepatic function, as defined in the protocol
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Who cannot join

  • Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL
  • History of or current relevant CNS pathology, as described in the protocol
  • Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (iAEs)
  • Prior therapies, as described in the protocol
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
  • Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay until the infection is well controlled.
Show all 11Show fewer
  • Known hypersensitivity to both allopurinol and rasburicase
  • Pregnant or breastfeeding women
  • Women of childbearing potential, or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose, as defined in the protocol
  • Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

30 sites in 6 countries.

30 sites in 6 countries

Spain11 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Institut Catala dOncologia (ICO Hospitalet)

    Barcelona, 08908

  • MD Anderson Cancer Center- Madrid

    Madrid, 28033

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008.0

Other trials in Spain

United States5 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Dana Farber/Harvard Cancer Center - PO box 849168

    Boston, Massachusetts, 02215

  • Harvard Medical School - Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

Other trials in United States

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Pratia Onkologia Katowice

    Katowice, 40-519

  • Pratia MCM Krakow

    Krakow, Malopolska, 30-510

  • Copernicus Memorial Hospital

    Lodz, 93-513

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa

    Warsaw, 02781

Other trials in Poland

Israel4 sites

  • Soroka

    Beersheba, 84101

  • Hadassah Medical Center

    Jerusalem, 91200

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Germany3 sites

  • University Hospital Frankfurt

    Frankfurt am Main, 60590

  • Universitatsklinikum Jena

    Jena, 7747

  • Universitatsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

Other trials in Germany

Austria2 sites

  • Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III

    Salzburg, 5020

  • Medical University Vienna

    Vienna, 1190

Other trials in Austria

About this study

Official title: A Phase 1 Study to Assess Safety and Tolerability of Odronextamab (REGN1979) an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and Cemiplimab (REGN2810), an Anti-Programmed Death-1 Monoclonal Antibody in Patients With B-Cell Malignancies (CLIO-1)

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)
Being tested
cemiplimab, odronextamab
Keywords
B-Cell Non-Hodgkin Lymphoma (B-NHL)
Medical subject headings
Recurrence, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cemiplimabDrug

    Also called REGN2810, Libtayo

    Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.

  • odronextamabDrug

    Also called REGN1979

    Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.

Study groups in NCT02651662
Study groupRoleWhat they receive
Dose escalation phaseExperimentalSafety assessment of odronextamab in combination with cemiplimab and selection of recommended phase 2 dose (RP2D) regimen(s) for the combination of odronextamab and cemiplimab.
Receives: Drug: cemiplimab; Drug: odronextamab
Dose expansion phaseExperimentalRP2D administration of the combination treatment.
Receives: Drug: cemiplimab; Drug: odronextamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab

    Measured: Up to 28 days

  2. Incidence of treatment emergent adverse events (TEAEs) of cemiplimab in combination with odronextamab

    Measured: Up to 18 months

  3. Severity of TEAEs of cemiplimab in combination with odronextamab

    Measured: Up to 18 months

  4. Incidence of adverse events of special interest (AESIs) of cemiplimab in combination with odronextamab

    Measured: Up to 18 months

  5. Severity of AESIs of cemiplimab in combination with odronextamab

    Measured: Up to 18 months

Secondary outcomes (8)

  1. Odronextamab and cemiplimab concentrations in serum

    Measured: Up to 18 months

  2. Incidence of anti-drug antibodies (ADAs) to odronextamab and cemiplimab over time

    Measured: Up to 18 months

  3. Titer of ADAs to odronextamab and cemiplimab over time

    Measured: Up to 18 months

  4. Incidence of neutralizing antibodies (Nabs) to odronextamab and cemiplimab over time

    Measured: Up to 18 months

  5. Titer of Nabs to odronextamab and cemiplimab over time

    Measured: Up to 18 months

  6. Overall response rate as assessed by investigator

    Measured: Up to 18 months

  7. Complete response (CR) rate as assessed by investigator

    Measured: Up to 18 months

  8. Duration of response as assessed by investigator

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2016 (estimated)
  2. Study start11 Jan 2016
  3. Primary completion29 Apr 2026
  4. Study completion29 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02651662
Sponsor's protocol ID
R1979-ONC-1504
Other IDs
2015-001697-17, 2023-508209-25-00, 2023, 2015
Acronym
CLIO-1
Status last verified
May 2026
First submitted
5 Jan 2016
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cemiplimab and odronextamab in people with Relapsed/Refractory Aggressive B-Cell Lymphoma, run by Regeneron Pharmaceuticals at 30 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain, United States, Poland, Israel, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab (time frame: Up to 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02651662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in