Recruiting

Phase 2

MogamulizumabA Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06698003

Conditions

T-Cell Leukemia/Lymphoma, Adult

T-cell Leukemia/Lymphoma

T-cell Leukemia

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mogamulizumab

Study Details

Brief summary:

The purpose of this study is to find out whether the study drug mogamulizumab is effective in preventing the development of adult T-cell leukemia/lymphoma (ATL) in people who are at higher risk for this type of cancer because they are infected with the HTLV-1 virus and because of changes seen in some of their immune system cells called T-cells.

Conditions

T-Cell Leukemia/Lymphoma, Adult

T-cell Leukemia/Lymphoma

T-cell Leukemia

Lymphoma

Study ID

NCT06698003

Start date

Nov 15, 2024

Status verified date

Mar, 2026

Completion date

Nov 15, 2029

Anticipated

Primary completion date

Nov 15, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Screening Cohort (US patients only):

Age ≥18 years when informed consent is obtained
Has freely given written informed consent to participate in the study

Treatment Cohorts (Cohorts 1 and 2):

Positive for anti-HTLV-1 antibody in the serum using an FDA approved assay for US patients (Avioq HTLV-I/II Microelisa System). UK patients should use UK Accreditation Service (UKAS) accredited tests, Abbot Architect ELISA Serology Screening assay and confirmatory serology Western Blot (performed at Public Health England, Virus Ref Dept, Colindale).
High-risk phenotype (PVL≥8% of PBMC)
Age ≥18 years when informed consent is obtained
Primary organ functions are stable

Neutrophil count: ≥ 1000/mm3, unless patient has diagnosis of ethnic neutropenia
Platelets: ≥100,000/mm3
Hemoglobin: ≥9.0 g/dL
Serum aspartate aminotransferase (AST): ≤1.5x upper limit of normal (ULN)
Alanine aminotransferase (ALT): ≤1.5x ULN
Total bilirubin: ≤1.5x ULN
Serum creatinine (Cr): ≤1.5x ULN
Blood oxygen saturation (SpO2): ≥90%
Electrocardiogram (ECG): No abnormal findings requiring treatment are observed
Has freely given written informed consent to participate in the study
For females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy. For males who have sexual intercourse with females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy.

Exclusion Criteria:

In order to protect subjects and avoid any problems in evaluating the study drug, patients who meet any of the following criteria should be excluded from enrollment in the study, in either screening or treatment cohorts:

Patients with a history of any of the following:

Neutrophil count: ≤1000/mm3, unless patient has diagnosis of ethnic neutropenia
Acute or chronic hepatitis or hepatic cirrhosis, other than patients with positive antibodies and negative PCR as noted in criteria #11 and #12 below.
Tuberculosis or with active tuberculosis
Myocardial infarction within 12 months prior to the date of enrollment
Allergic reaction to administration of antibody drug products
Other cancers. Patients with a history of a localized solid tumor who received definitive, curative treatment and who have been without evidence of disease for 5 years prior to enrollment will be able to enroll in the study. Patients with radically resected basal cell carcinoma of the skin, squamous cell carcinoma (except malignant melanoma), noninvasive cervix carcinoma, carcinoma in situ in the gastrointestinal tract or corpus of the uterus, localized thyroid cancer, and localized renal cell carcinoma will be able to enroll in the study if they are determined to be completely cured, even if within 5 years of enrollment.
Prior treatment with immunosuppressants or interferon alpha products within 6 months prior to the date of enrollment
Serious complications (heart failure, lung disease, renal failure, hepatic failure, uncontrolled diabetes mellitus, etc.)
History of an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Any ailment that could be exacerbated by the administration of KW-0761, in the judgment of the Principal Investigator or co-Investigator
Diagnosis of ATL
Women who are pregnant, breastfeeding, who may be pregnant, or wish to bear children while receiving treatment or within 3 months of last dose of mogamulizumab
Patients who have taken multivitamins (Alinamin, vitamin C, etc.) or supplements such as fucoidan, catechin, and pentosan polysulfate within 2 weeks prior to the date of enrollment
Prior treatment with other study drugs within 4 months prior to giving informed consent
Complications of spinal cord compressive lesions such as cervical spine disease, disc herniation, and ossification of the yellow ligament
Uncontrolled psychiatric disorder, epilepsy, or dementia
Positive test for Hepatitis B surface antigen or HBV-DNA (using real-time PCR). Positive Hepatitis B core antibody is permitted if HBV-DNA PCR is negative and the patient remains on prophylaxis during study.
Positive test for Hepatitis C virus antibody, unless Hepatitis C PCR is negative.
Positive test for HIV antibody, unless undetectable HIV RNA > 6 months and CD4 within normal limits per institutional standard.
Patients considered unqualified to participate in the study by the Principal Investigator or co-Investigator

Study Design

Enrollment

134 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Cohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses

experimental: Cohort 2

Cohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses

Interventions

Mogamulizumab

Cohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses Cohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses

Primary outcome measure

Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75% [ Time Frame: 6 months from baseline ]

Central Contacts and Locations

Central contacts

Steven Horwitz, MD

646-608-2680 horwitzs@MSKCC.ORG

Alison Moskowitz, MD

646-608-3726 moskowia@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Steven Horwitz, MD

646-608-2680

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Steven Horwitz, MD

646-608-2680

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Steven Horwitz, MD

646-608-2680

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Steven Horwitz, MD

646-608-2680

Memorial Sloan Kettering Westchester (All protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Steven Horwitz, MD

646-608-2680

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Steven Horwitz, MD

646-608-2680

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Steven Horwitz, MD

646-608-2680

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

T-Cell Leukemia/Lymphoma, Adult
T-cell Leukemia/Lymphoma
T-cell leukemia
Lymphoma
Mogamulizumab
HTLV-1
Memorial Sloan Kettering Cancer Center
21-486

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-03-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.