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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04860466
• Other study ID #: CC-96673-NHL-001
• Secondary ID: 2020-004631-24
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 20, 2022
• Est. completion date: August 20, 2025

Study information

• Verified date: October 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 20, 2025
• Est. primary completion date: August 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 SIRPa.

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• CC-96673
IV Infusion

Locations

Country	Name	City	State
Canada	Local Institution - 202	Montreal	Quebec
Canada	Local Institution - 201	Toronto	Ontario
France	Hopital Claude Huriez	Lille
France	CHU Montpellier - Hôpital Saint Eloi	Montpellier CEDEX 5
France	Hopital Lyon Sud	Pierre Benite
Spain	Local Institution - 401	Madrid
Spain	Local Institution - 403	Malaga
Spain	Local Institution - 402	Salamanca
United States	Local Institution - 101	Houston	Texas
United States	Local Institution - 104	Minneapolis	Minnesota
United States	Local Institution - 103	Omaha	Nebraska
United States	Local Institution - 102	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dose-limiting toxicity (DLT)	Number of participants with a DLT	Up to approximately 18 months
Primary	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	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
Secondary	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
Secondary	Duration of response (DOR)	Is defined as the time from tumor response to progression/death	Up to 2 years after study treatment
Secondary	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
Secondary	Pharmacokinetics - Cmax	Maximum observed serum concentration of drug	Up to 24 Months
Secondary	Pharmacokinetics - AUC	Area under the serum concentration-time curve	Up to 24 Months
Secondary	Pharmacokinetics - tmax	Time of maximum observed serum concentration	Up to 24 Months
Secondary	Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies		Up to 24 Months

External Links

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