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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia/Lymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1

A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1 (NCT06698003) is a Phase 2 interventional studying T-Cell Leukemia/Lymphoma, Adult and T-cell Leukemia/Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against T-Cell Leukemia/Lymphoma, Adult and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 134 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused T-Cell Leukemia/Lymphoma, Adult subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Screening Cohort (US patients only): - Age ≥18 years when willing to sign a consent form is obtained - Has freely given written willing to sign a consent form 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 willing to sign a consent form 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

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

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06698003), the sponsor (Memorial Sloan Kettering Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06698003 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06698003?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06698003?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06698003. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06698003. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.