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

NCT04860466 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CC-96673-NHL-0012020-004631-24
• Study Type: interventional
• Target: 9
• Locations: 4 countries
• Sites: 13

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.

Conditions

Lymphoma, Non-Hodgkin

Keywords

Relapsed or Refractory; Non-Hodgkin's Lymphoma; CC-96673; Dose Finding

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Overall response rate (ORR)

  Up to 2 years after study treatment

• Time to response (TTR)

  Up to 2 years after study treatment

• Duration of response (DOR)

  Up to 2 years after study treatment

• Progression free survival (PFS)

  Up to 2 years after study treatment

• Pharmacokinetics - Cmax

  Up to 24 Months

Study Arms (1)

Administration of CC-96673

EXPERIMENTAL

CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule

Drug: CC-96673

Interventions

CC-96673 DRUG

IV Infusion

Administration of CC-96673

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (13)

Local Institution - 104

Minneapolis, Minnesota, 55455, United States

Location

Local Institution - 103

Omaha, Nebraska, 68198-6840, United States

Location

Local Institution - 101

Houston, Texas, 77030, United States

Location

Local Institution - 102

Seattle, Washington, 98124, United States

Location

Local Institution - 201

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 202

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - UNK-5

Angers, 49933, France

Location

Local Institution - 303

Lille, 59037, France

Location

Local Institution - 302

Montpellier, 34295, France

Location

Hopital Lyon Sud

Pierre-Bénite, 69310, France

Location

Local Institution - 401

Madrid, 28027, Spain

Location

Local Institution - 403

Málaga, 29010, Spain

Location

Local Institution - 402

Salamanca, 37007, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: January 20, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

FR (4); CA (2); US (4); ES (3)