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Monoclonal Antibodies

Odronextamab + Cemiplimab for Aggressive B-Cell Lymphoma (CLIO-1 Trial)

Phase 1
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function
Adequate bone marrow function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

CLIO-1 Trial Summary

This trial is studying cemiplimab and REGN1979 to see how well they work in treating patients with lymphoma. The study will last 6-12 months, and participants will be monitored for 6 months after treatment.

Who is the study for?
Adults with aggressive B-cell lymphoma that's come back or hasn't responded to treatment, and no standard care options are left. They must have a life expectancy over 6 months, good organ function, measurable disease by imaging, and be able to follow the study plan. Excluded are those with certain infections (HIV/hepatitis), CNS lymphoma involvement, allergy to tetracycline antibiotics, unwillingness to use contraception, recent significant autoimmune disease needing immunosuppressants, prior specific cancer treatments including stem cell transplant or PD-1/PD-L1 inhibitors (unless beneficial), known allergies relevant here.Check my eligibility
What is being tested?
The trial is testing how safe and tolerable two experimental drugs—odronextamab (REGN1979) and cemiplimab (REGN2810)—are when combined in adults with relapsed/refractory aggressive B-cell lymphoma. It aims to find the best dose regimen for this combination therapy while also examining side effects effectiveness against the disease levels of drug in blood over time potential development of antibodies against these drugs.See study design
What are the potential side effects?
Potential side effects from odronextamab and cemiplimab may include reactions at the infusion site fatigue fever chills nausea vomiting diarrhea rash breathing difficulties changes in blood pressure liver enzyme elevations immune-related adverse events like inflammation of organs which could manifest as colitis pneumonitis hepatitis endocrinopathies etc.

CLIO-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs are working well.
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My bone marrow is working well.
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I am fully active or can carry out light work.
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My lymphoma is not responding to treatment and there are no standard treatments left for me.
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I have a tumor that can be measured and is larger than 1.5 cm.

CLIO-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events of special interest (AESIs) of cemiplimab in combination with odronextamab
Incidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab
Incidence of treatment emergent adverse events (TEAEs) of cemiplimab in combination with odronextamab
+2 more
Secondary outcome measures
Complete response (CR) rate as assessed by investigator
Duration of response as assessed by investigator
Incidence of anti-drug antibodies (ADAs) to odronextamab and cemiplimab over time
+5 more

Side effects data

From 2023 Phase 2 trial • 138 Patients • NCT03132636
43%
Fatigue
37%
Diarrhoea
22%
Constipation
20%
Hypertension
17%
Arthralgia
15%
Pruritus
15%
Weight increased
13%
Vomiting
13%
Pyrexia
11%
Nausea
11%
Anaemia
11%
Decreased appetite
11%
Pain in extremity
11%
Headache
11%
Oedema peripheral
11%
Hyperglycaemia
9%
Asthenia
9%
Back pain
9%
Dry skin
9%
Rash maculo-papular
9%
Dizziness
9%
Eczema
9%
Weight decreased
9%
Hyperthyroidism
7%
Abdominal pain
7%
Hypokalaemia
7%
Urinary tract infection
7%
Rash
7%
Cough
7%
Dyspnoea
7%
Hypothyroidism
7%
Neck pain
7%
Blood creatine phosphokinase increased
7%
Blood creatinine increased
7%
Fall
7%
Haematuria
6%
Anxiety
6%
Pain
6%
Myalgia
6%
Actinic keratosis
6%
Upper respiratory tract infection
6%
Alanine aminotransferase increased
6%
Muscle spasms
6%
Basal cell carcinoma
6%
Dry mouth
6%
Infusion related reaction
4%
Influenza like illness
4%
Colitis
2%
Arthritis bacterial
2%
Pneumonia
2%
Pancytopenia
2%
Clostridium difficile infection
2%
Skin infection
2%
Infection
2%
Pneumonitis
2%
Respiratory failure
2%
Atypical pneumonia
2%
Pneumonia staphylococcal
2%
Somnolence
2%
Facial paralysis
2%
Lymphoproliferative disorder
2%
Lymphadenopathy mediastinal
2%
Multiple fractures
2%
Procedural pain
2%
Tibia fracture
2%
Hypoalbuminaemia
2%
Autoimmune pericarditis
2%
Urinary retention
2%
General physical health deterioration
2%
Wound haemorrhage
2%
Pleural effusion
2%
Haemoptysis
2%
Acute coronary syndrome
2%
Atrial fibrillation
2%
Autoimmune myocarditis
2%
Tumour haemorrhage
2%
Seborrhoeic keratosis
2%
Immune-mediated myocarditis
2%
Autoimmune hepatitis
2%
Clostridium difficile colitis
2%
Leukocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Metastatic BCC (mBCC)
Group 2: Unresectable Locally Advanced BCC (laBCC)

CLIO-1 Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose expansion phaseExperimental Treatment2 Interventions
RP2D administration of the combination treatment.
Group II: Dose escalation phaseExperimental Treatment2 Interventions
Safety assessment of odronextamab in combination with cemiplimab and selection of recommended phase 2 dose (RP2D) regimen(s) for the combination of odronextamab and cemiplimab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
FDA approved

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
379,696 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
258 Previous Clinical Trials
250,936 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02651662 — Phase 1
Aggressive B-Cell Lymphoma Research Study Groups: Dose escalation phase, Dose expansion phase
Aggressive B-Cell Lymphoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT02651662 — Phase 1
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02651662 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents of research involving cemiplimab?

"At this time, 58 separate clinical trials are undergoing research on cemiplimab with 4 in the late stages of development. While Barcelona and California have a significant number of ongoing studies for cemiplimab, there are 1978 different sites conducting these tests worldwide."

Answered by AI

Is enrollment for this trial still open?

"As detailed on clinicaltrials.gov, the initial post for this trial was made in November of 2016 and last edited in September 2022; however, it is not currently seeking participants. Fortunately, there are 1776 other medical studies accepting patients at present."

Answered by AI

At how many venues can participants access this experiment?

"At the present moment, 9 distinct clinical sites are enrolling patients into this trial. These centres can be found in Lebanon, Baltimore and Grand Rapids as well as other nearby locations to reduce potential travel burdens for participants if they choose to take part."

Answered by AI

Has cemiplimab received the green light from the Food and Drug Administration?

"Cemiplimab's safety has yet to be fully established due to its Phase 1 trial status, and thus it recieved a score of 1."

Answered by AI

What is the current enrollment rate for this clinical research trial?

"At the present time, this clinical trial is not recruiting. It was initially posted on 11th January 2016 and last updated on 20th September 2022. Alternately, if you are seeking other studies there are 1718 trials actively looking for lymphoma patients while 58 of such trials require participants with cemiplimab."

Answered by AI

What medical conditions is cemiplimab regularly used to treat?

"Through the use of cemiplimab, it is possible to address alk gene mutation, anticipate medical decisions through advance directives, and combat malignant neoplasms."

Answered by AI
~15 spots leftby Dec 2026