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

NCT06698003 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 21-486
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 7

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75%

  To define the minimum efficacious dose and schedule of mogamulizumab to reduce the proviral load by ≥75% by pre-emptive treatment of HTLV-1 carriers with a limited course of mogamulizumab. The minimum efficacious dose will maintain ≥75% reduction in PVL from baseline levels for a minimum 6 months post completion of preemptive treatment with a limited course of mogamulizumab.

  6 months from baseline

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: Mogamulizumab

Cohort 2

EXPERIMENTAL

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

Drug: Mogamulizumab

Interventions

Mogamulizumab DRUG

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

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, T-Cell; Lymphoma

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Steven Horwitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Horwitz, MD

CONTACT

646-608-2680; horwitzs@MSKCC.ORG

Alison Moskowitz, MD

CONTACT

646-608-3726; moskowia@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): November 15, 2029
• Study Completion (Estimated): November 15, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)