A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma, Non-Hodgkin
• Intervention / Treatment: Drug: CC-96673

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 201
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Local Institution - 202
• France
  • Lille, France, 59037
    • Hôpital Claude Huriez
  • Montpellier CEDEX 5, France, 34295
    • CHU Montpellier - Hôpital Saint Eloi
  • Pierre Benite, France, 69310
    • Hopital Lyon Sud
• Spain
  • Madrid, Spain, 28027
    • Local Institution - 401
  • Malaga, Spain, 29010
    • Local Institution - 403
  • Salamanca, Spain, 37007
    • Local Institution - 402
• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Local Institution - 104
  • Nebraska
    • Omaha, Nebraska, United States, 68198-6840
      • Local Institution - 103
  • Texas
    • Houston, Texas, United States, 77030
      • Local Institution - 101
  • Washington
    • Seattle, Washington, United States, 98124
      • Local Institution - 102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

1. Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
3. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
4. Participant must have a history of NHL that has relapsed or progressed.
5. Participant has an ECOG PS of 0 or 1.
6. Participants must have acceptable laboratory values as specified in the protocol.

Exclusion Criteria:

1. Participant has cancer with symptomatic central nervous system (CNS) involvement
2. 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.
3. Inadequate cardiac function or significant cardiovascular disease
4. Participant has received prior investigational therapy directed at CD47 or SIRPα.
5. Participant had major surgery ≤ 2 weeks prior to starting CC-96673.
6. Participant is a pregnant or lactating female or intends to become pregnant during participation of the study.
7. Participant has known active human immunodeficiency virus (HIV) infection.
8. Participant has active hepatitis B or C (HBV/HCV) infection.
9. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
10. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
11. History of concurrent second cancers requiring active, ongoing systemic treatment.
12. Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
13. Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of CC-96673; CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule	Drug: CC-96673; IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)	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.	From enrollment until at least 28 days after completion of study treatment
Dose-limiting toxicity (DLT)	Number of participants with a DLT	Up to approximately 18 months
Maximum tolerated dose (MTD)	Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.	Up to approximately 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Is defined as the percent of participants whose best response is CR or PR	Up to 2 years after study treatment
Time to response (TTR)	Is defined as the time from the first dose of CC-96673 to tumor response	Up to 2 years after study treatment
Duration of response (DOR)	Is defined as the time from tumor response to progression/death	Up to 2 years after study treatment
Progression free survival (PFS)	Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause	Up to 2 years after study treatment
Pharmacokinetics - Cmax	Maximum observed serum concentration of drug	Up to 24 Months
Pharmacokinetics - AUC	Area under the serum concentration-time curve	Up to 24 Months
Pharmacokinetics - tmax	Time of maximum observed serum concentration	Up to 24 Months
Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies		Up to 24 Months

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Estimated): August 20, 2025
• Study Completion (Estimated): August 20, 2025

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dose Finding; Non-Hodgkin's Lymphoma; Relapsed or Refractory; CC-96673
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: CC-96673-NHL-001; 2020-004631-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No