Clinical trial NCT04860466: A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Keywords: Relapsed or Refractory
Non-Hodgkin's Lymphoma
CC-96673
Dose Finding
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: From enrollment until at least 28 days after completion of study treatment
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to approximately 18 months
measure: Maximum tolerated dose (MTD)
timeFrame: Up to approximately 18 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to 2 years after study treatment
measure: Time to response (TTR)
timeFrame: Up to 2 years after study treatment
measure: Duration of response (DOR)
timeFrame: Up to 2 years after study treatment
measure: Progression free survival (PFS)
timeFrame: Up to 2 years after study treatment
measure: Pharmacokinetics - Cmax
timeFrame: Up to 24 Months
measure: Pharmacokinetics - AUC
timeFrame: Up to 24 Months
measure: Pharmacokinetics - tmax
timeFrame: Up to 24 Months
measure: Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Local Institution - 104
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 103
state: Nebraska
city: Houston
country: United States
facility: Local Institution - 101
state: Texas
city: Seattle
country: United States
facility: Local Institution - 102
state: Washington
city: Toronto
country: Canada
facility: Local Institution - 201
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 202
state: Quebec
city: Angers
country: France
facility: Local Institution - UNK-5
city: Lille
country: France
facility: Local Institution - 303
city: Montpellier CEDEX 5
country: France
facility: Local Institution - 302
city: Pierre Benite
country: France
facility: Hopital Lyon Sud
city: Madrid
country: Spain
facility: Local Institution - 401
city: Malaga
country: Spain
facility: Local Institution - 403
city: Salamanca
country: Spain
facility: Local Institution - 402
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: