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Lymphoma, Non-HodgkinPhase 1NCT04860466

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

A Phase 1 study testing CC-96673 in people with Lymphoma, Non-Hodgkin, run by Celgene at 13 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
CC-96673
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
13 sitesin 4 countries
Study dates
20 Jan 2022to 31 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

United States4 sites

  • Local Institution - 101

    Houston, Texas, 77030

  • Local Institution - 104

    Minneapolis, Minnesota, 55455

  • Local Institution - 103

    Omaha, Nebraska, 68198-6840

  • Local Institution - 102

    Seattle, Washington, 98124

Other trials in United States

France4 sites

  • Local Institution - UNK-5

    Angers, 49933

  • Local Institution - 303

    Lille, 59037

  • Local Institution - 302

    Montpellier, 34295

  • Hopital Lyon Sud

    Pierre-Bénite, 69310

Other trials in France

Spain3 sites

  • Local Institution - 401

    Madrid, 28027

  • Local Institution - 403

    Málaga, 29010

  • Local Institution - 402

    Salamanca, 37007

Other trials in Spain

Canada2 sites

  • Local Institution - 202

    Montreal, Quebec, H3T 1E2

  • Local Institution - 201

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Being tested
CC-96673
Keywords
Relapsed or Refractory, Non-Hodgkin's Lymphoma, CC-96673, Dose Finding
Medical subject headings
Lymphoma, Non-Hodgkin, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-96673Drug

    IV Infusion

Study groups in NCT04860466
Study groupRoleWhat they receive
Administration of CC-96673ExperimentalCC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
Receives: Drug: CC-96673

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment until at least 28 days after completion of study treatment

  2. Dose-limiting toxicity (DLT)

    Number of participants with a DLT

    Measured: Up to approximately 18 months

  3. 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%.

    Measured: Up to approximately 18 months

Secondary outcomes (8)

  1. Overall response rate (ORR)

    Is defined as the percent of participants whose best response is CR or PR

    Measured: Up to 2 years after study treatment

  2. Time to response (TTR)

    Is defined as the time from the first dose of CC-96673 to tumor response

    Measured: Up to 2 years after study treatment

  3. Duration of response (DOR)

    Is defined as the time from tumor response to progression/death

    Measured: Up to 2 years after study treatment

  4. 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

    Measured: Up to 2 years after study treatment

  5. Pharmacokinetics - Cmax

    Maximum observed serum concentration of drug

    Measured: Up to 24 Months

  6. Pharmacokinetics - AUC

    Area under the serum concentration-time curve

    Measured: Up to 24 Months

  7. Pharmacokinetics - tmax

    Time of maximum observed serum concentration

    Measured: Up to 24 Months

  8. Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies

    Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start20 Jan 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Why it stopped: Business objectives have changed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860466
Sponsor's protocol ID
CC-96673-NHL-001
Other IDs
2020-004631-24
Status last verified
Sep 2024
First submitted
22 Apr 2021
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-96673 in people with Lymphoma, Non-Hodgkin, run by Celgene at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, France, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: From enrollment until at least 28 days after completion of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860466.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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