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Monoclonal Antibody

CC-95251 for Blood Cancers

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern cooperative oncology group performance status of 0 or 1

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 months

Awards & highlights

Study Summary

This trial is testing a new drug, CC-95251, to see if it is safe and effective against solid and blood cancers.

Who is the study for?

This trial is for adults with advanced solid tumors or blood cancers who have measurable disease, are in good physical condition (able to perform daily activities), and whose cancer has worsened despite standard treatments. It's not for those with high-grade lymphomas, recent severe heart issues, or cancer affecting the brain causing symptoms.Check my eligibility

What is being tested?

The study tests CC-95251 alone and combined with cetuximab (for certain solid tumors) or rituximab (for specific blood cancers). The goal is to assess safety and early signs of effectiveness in treating these advanced cancers.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, allergic responses, fatigue, nausea. Since CC-95251 is new, part of this study's purpose is to learn more about its side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 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

Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria

Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects

Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects

Secondary outcome measures

Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies

Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented

Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: CC-95251 in combination with rituximabExperimental Treatment2 Interventions

CC-95251 administered by IV (intravenous) infusion; Rituximab administered by IV (intravenous) infusion.

Group II: CC-95251 in combination with cetuximabExperimental Treatment2 Interventions

CC-95251 administered by IV (intravenous) infusion; Cetuximab administered by IV (intravenous) infusion.

Group III: CC-95251Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Cetuximab

2011

Completed Phase 3

~2480

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,741 Total Patients Enrolled

1 Trials studying Tumors

107 Patients Enrolled for Tumors

Amar Patel, MDStudy DirectorCelgene

6 Previous Clinical Trials

560 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,300 Total Patients Enrolled

8 Trials studying Tumors

422 Patients Enrolled for Tumors

Media Library

CC-95251 (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT03783403 — Phase 1

Tumors Research Study Groups: CC-95251, CC-95251 in combination with rituximab, CC-95251 in combination with cetuximab

Tumors Clinical Trial 2023: CC-95251 Highlights & Side Effects. Trial Name: NCT03783403 — Phase 1

CC-95251 (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03783403 — Phase 1

Frequently Asked Questions

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

How many venues are hosting this experiment?

"Currently, this medical trial is recruiting from 21 different centres across the continent. San Antonio, Toronto and Aurora are among these sites alongside 18 others. If you choose to participate in the study, it's best to select a centre close by so that travel costs can be kept low."

Answered by AI

Has the government given its stamp of approval to CC-95251?

"The safety of CC-95251 receives a score of 1 as there is only limited clinical information supporting its efficacy and security."

Answered by AI

Is there an open enrollment period for this medical experiment?

"Confirmed. Current information on clinicaltrials.gov reveals that this medical research, which was first made available on February 1st 2019, is seeking participants. Over 230 individuals are needed from 21 different trial sites."

Answered by AI

What is the exact cohort size for this clinical trial?

"To complete this research, a total of 230 participants that meet the criteria must be recruited. Participants can join from South Texas Accelerated Research Therapeutics in San Antonio or Local Institution - 202 in Toronto."

Answered by AI

What medical conditions have been addressed with the application of CC-95251?

"CC-95251 has been known to combat b-cell lymphomas and other maladies such as polyangium, squamous cell carcinoma, and rheumatoid arthritis."

Answered by AI

What other explorations have been conducted involving CC-95251?

"CC-95251 was first trialled back in 1993 at the NIH Clinical Centre, 9000 Rockville Pike. Since then 1174 studies have been completed and 526 active trials are currently being conducted; a large chunk of these experiments take place in San Antonio, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

2019. "A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03783403.

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