A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT04860466 |
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Recruitment Status :
Recruiting
First Posted : April 27, 2021
Last Update Posted : February 14, 2023
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
- Study Details
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Brief Summary:
The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).
The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Non-Hodgkin | Drug: CC-96673 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma |
| Actual Study Start Date : | January 20, 2022 |
| Estimated Primary Completion Date : | August 20, 2025 |
| Estimated Study Completion Date : | March 1, 2029 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Administration of CC-96673
CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
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Drug: CC-96673
IV Infusion |
Primary Outcome Measures :
- Incidence of Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
- Dose-limiting toxicity (DLT) [ Time Frame: Up to approximately 18 months ]Number of participants with a DLT
- Maximum tolerated dose (MTD) [ Time Frame: Up to approximately 18 months ]Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.
Secondary Outcome Measures :
- Overall response rate (ORR) [ Time Frame: Up to 2 years after study treatment ]Is defined as the percent of participants whose best response is CR or PR
- Time to response (TTR) [ Time Frame: Up to 2 years after study treatment ]Is defined as the time from the first dose of CC-96673 to tumor response
- Duration of response (DOR) [ Time Frame: Up to 2 years after study treatment ]Is defined as the time from tumor response to progression/death
- Progression free survival (PFS) [ Time Frame: Up to 2 years after study treatment ]Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause
- Pharmacokinetics - Cmax [ Time Frame: Up to 24 Months ]Maximum observed serum concentration of drug
- Pharmacokinetics - AUC [ Time Frame: Up to 24 Months ]Area under the serum concentration-time curve
- Pharmacokinetics - tmax [ Time Frame: Up to 24 Months ]Time of maximum observed serum concentration
- Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies [ Time Frame: Up to 24 Months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
- Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant must have a history of NHL that has relapsed or progressed.
- Participant has an ECOG PS of 0 or 1.
- Participants must have acceptable laboratory values as specified in the protocol.
Exclusion Criteria:
- Participant has cancer with symptomatic central nervous system (CNS) involvement
- Participant is on chronic systemic immunosuppressive therapy or corticosteroids or subjects with clinically significant graft-versus-host disease (GVHD). Intranasal, inhaled, topical, or local corticosteroid injections, or steroids as premedication for hypersensitivity reactions are exceptions to this criterion.
- Inadequate cardiac function or significant cardiovascular disease
- Participant has received prior investigational therapy directed at CD47 or SIRPα.
- Participant had major surgery ≤ 2 weeks prior to starting CC-96673.
- Participant is a pregnant or lactating female or intends to become pregnant during participation of the study.
- Participant has known active human immunodeficiency virus (HIV) infection.
- Participant has active hepatitis B or C (HBV/HCV) infection.
- Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
- History of concurrent second cancers requiring active, ongoing systemic treatment.
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860466
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain the NCT# and Site #. |
Locations
| United States, Minnesota | |
| University Of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Veronika Bachanova, Site 104 612-625-5469 | |
| United States, Nebraska | |
| University Of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-6840 | |
| Contact: Christopher D'Angelo, Site 103 | |
| United States, Texas | |
| The University of Texas - MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Paolo Strati, Site 101 713-745-1776 | |
| United States, Washington | |
| Swedish Health Services | Recruiting |
| Seattle, Washington, United States, 98124 | |
| Contact: Krish Patel, Site 102 206-215-6196 | |
| Canada, Ontario | |
| Local Institution - 201 | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Site 201 | |
| Canada, Quebec | |
| Local Institution - 202 | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Contact: Site 202 | |
| France | |
| Local Institution - 303 | Recruiting |
| Lille, France, 59037 | |
| Contact: Site 303 | |
| CHU Montpellier - Hôpital Saint Eloi | Recruiting |
| Montpellier CEDEX 5, France, 34295 | |
| Contact: Guillaume Cartron, Site 302 33 4 67 33 80 79 | |
| Local Institution - 304 | Recruiting |
| Pierre Benite, France, 69310 | |
| Contact: Site 304 | |
| Spain | |
| Local Institution - 401 | Recruiting |
| Madrid, Spain, 28027 | |
| Contact: Site 401 | |
| Local Institution - 403 | Recruiting |
| Malaga, Spain, 29010 | |
| Contact: Site 403 | |
| Local Institution - 402 | Recruiting |
| Salamanca, Spain, 37007 | |
| Contact: Site 402 | |
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT04860466 |
| Other Study ID Numbers: |
CC-96673-NHL-001 2020-004631-24 ( EudraCT Number ) |
| First Posted: | April 27, 2021 Key Record Dates |
| Last Update Posted: | February 14, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/ |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | See Plan Description |
| Access Criteria: | See Plan Description |
| URL: | https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Celgene:
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Relapsed or Refractory Non-Hodgkin's Lymphoma CC-96673 Dose Finding |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |