A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas

Stopped early · Phase 1

Conditions studied: Lymphoma

In brief

This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).

Key facts

Study ID

NCT04464798

Run by

Celgene

People needed

62

Starts

2020-11-11

Expected to finish

2025-01-09

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must satisfy the following criteria to be enrolled in the study:
• Is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Has histologically confirmed (per local evaluation) diagnosis of lymphoma according to 2016 World Health Organization (WHO) classification including:
• Cohort A: all subtypes including B-cell, T-cell and Natural killer (NK)-cell Non-Hodgkin lymphoma (NHL), and Classical Hodgkin lymphoma (cHL).
• Cohort B: all B-cell NHL.
• Cohort C: FL Grade 1-3a and MZL including extranodal marginal zone lymphoma (ENMZL) of mucosa-associated lymphoid tissue (MALT lymphoma), nodal marginal zone lymphoma (NMZL) and splenic marginal zone lymphoma (SMZL)
• Cohort D: aggressive B-cell lymphoma and FL grade 1-3a
• Cohort E: aggressive B-cell lymphoma including DLBCL NOS, high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements, Grade 3b FL and PMBCL
• Cohorts F and G: FL Grade 1 to 3a
• Relapsed or refractory disease according to the following definitions:
• Aggressive B-cell lymphoma
• Follicular lymphoma (FL) and Marginal zone lymphoma (MZL): following at least 2 prior lines of systemic therapy (being previously exposed to at least 1 anti-CD20 mAb and 1 alkylating agent).
• Mantle cell lymphoma (MCL): following at least 2 prior lines of therapy including at least 1 immunochemotherapy and 1 bruton tyrosine kinase (BTK) inhibitor.
• Peripheral T-cell lymphoma (PTCL): following at least 2 prior lines of therapy OR after 1 prior line of standard therapy and being not eligible for any other approved regimen.
• Classical Hodgkin lymphoma (cHL): following at least 2 prior systemic lines of therapy and previously exposed to brentuximab vedotin and anti-PD1.
• All other subtypes: following at least 2 prior lines of therapy.
• Subjects previously treated with CAR-T therapy can be enrolled (irrespective of the indication).
• Subjects must not be eligible for any other approved treatment for their underlying lymphoma as assessed by the Investigator.
• Must have measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification. Site of measurable disease cannot be previously irradiated.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Must have the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L
• Hemoglobin (Hb) ≥ 8 g/dL.
• Platelets (Plt) ≥ 75 x 109/L or ≥ 50 x 109/L
• Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN.

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment:
• Any significant medical condition, active infection (including severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2) suspected or confirmed, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Life expectancy ≤ 3 months.
• Diagnosis of lymphoblastic lymphoma.
• Aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location).
• Prior Grade 3 or 4 infusion related reaction with rituximab (for Cohorts B, E and F) or obinutuzumab (for Cohorts C and G).
• Prior therapy with the cereblon-modulating drug CC-99282.
• Chronic systemic immunosuppressive therapy or corticosteroids.
• Prior ASCT ≤ 3 months prior to starting CC-220 or > 3 months AND with unresolved, Grade > 1, treatment-related toxicity.
• Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-220 or > 6 months with unresolved, Grade > 1, treatment-related toxicity.
• Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or obinutuzumab.
• Known allergy to thalidomide, pomalidomide or lenalidomide.
• Inability or unwilling to undergo protocol required thromboembolism prophylaxis.
• Major surgery ≤ 2 weeks prior to starting CC-220;
• Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).
• Documented or suspected central nervous system (CNS) involvement of disease.
• Subject with clinically significant cardiac disease.
• Known seropositivity for or active viral infection with human immunodeficiency virus (HIV).
• Known chronic active hepatitis B
• History of other malignancy, unless the subject has been free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following:
• Incidental histologic finding of prostate cancer (or prostate cancer that has been treated with curative intent
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Local Institution - 106 — Phoenix, Arizona, United States
• Local Institution - 105 — Lake Mary, Florida, United States
• Local Institution - 102 — Rochester, Minnesota, United States
• Local Institution - 100 — New York, New York, United States
• University of Rochester Cancer Center — Rochester, New York, United States
• Local Institution - 103 — Nashville, Tennessee, United States
• Local Institution - 203 — Créteil, France
• Local Institution - 200 — Lillie Cedex, France
• Local Institution - 201 — Montpellier, France
• Local Institution - 202 — Nantes, France
• Local Institution - 204 — Paris, France
• Local Institution - 205 — Pessac, France
• Local Institution - 401 — Berlin, Germany
• Local Institution - 402 — Leipzig, Germany
• Local Institution - 403 — Münster, Germany
• Local Institution - 404 — Würzburg, Germany
• Local Institution - 300 — Brescia, Italy
• Local Institution - 303 — Milan, Italy
• Local Institution - 301 — Pavia, Italy
• Local Institution - 302 — Verona, Italy
• Local Institution - 502 — Seoul, South Korea
• Local Institution - 501 — Seoul, South Korea
• Local Institution - 500 — Seoul, South Korea
• Local Institution - 600 — Niaosong District Kaohsiung City, Taiwan
• Local Institution - 601 — Taoyuan City, Taiwan

Full record on ClinicalTrials.gov

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