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NCT07192471PHASE1Recruiting

A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin Lymphoma

Kyowa Kirin, Inc.

Start Date

9/2/2026

Completion Date

9/1/2030

Summary

The purpose of this study is to determine the safety, tolerability, PK and pharmacodynamics of KK2223 in adult participants with relapsed or refractory peripheral T cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL).

Detailed Description

This is a Phase 1, multicenter, open-label, non randomized study in participants with relapsed or refractory PTCL or CTCL. This study consists of Part 1 (dose-escalation) and Part 2 (backfill). The purpose of this study is to determine the safety, tolerability, PK and pharmacodynamics of K2223 in r/r T-cell NHL (PTCL or CTCL)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adults (≥18 years) with confirmed T-cell lymphoma subtypes: PTCL (including nodal T-follicular helper cell lymphoma, ALCL, PTCL NOS) for Parts 1 and 2; CTCL (mycosis fungoides or Sézary syndrome, stages IIB-IV) for Parts 1 and 2, with specific disease involvement criteria in Part 2. * PTCL participants must have relapsed/refractory/intolerant to ≥1 systemic therapy; CD30+ PTCL must have prior brentuximab vedotin treatment or intolerance, and/or ALK-positive ALCL participants should have previously received crizotinib if indicated (crizotinib administration is applicable to US sites only). CTCL participants must have relapsed/refractory/intolerant to ≥2 systemic therapies. * Availability of tumor tissue (current or archival) is required. * Measurable disease required: nodal/extranodal lesions for PTCL and assessable skin disease for CTCL. * ECOG performance status 0-1; adequate neutrophils (≥1000/µL), platelets (≥75,000/µL), renal function (creatinine clearance ≥60 mL/min), liver function within defined limits, and total bilirubin ≤1.5× ULN (up to 3× ULN with Gilbert's syndrome). * Body weight 40 kg to ≤ 200 kg * Life expectancy ≥3 months. * Negative pregnancy test for females of childbearing potential; contraception required for females and males with partners of childbearing potential during and after treatment. * Restrictions on gamete donation and freezing during and after treatment. * Ability to provide informed consent and comply with study procedures. - Exclusion Criteria: * Recent autologous or allogeneic transplant within 120 days before treatment; active GVHD or ongoing immunosuppression after allogeneic transplant; prior HSCT and with active VOD/SOS * Pregnant or breastfeeding females, or those intending pregnancy. * History of HIV, HBV, or HCV infections generally excluded, except for controlled or resolved cases as defined. * Uncontrolled infections requiring antibiotics, antivirals, or antifungals at screening through treatment start. * Significant medical history or complications within six months prior to enrollment, including advanced congestive heart failure (NYHA Class III or higher), recent unstable angina or myocardial infarction, autoimmune diseases requiring systemic immunosuppressive therapy, active or uncontrolled ocular diseases, Grade 3 or 4 peripheral neuropathy, or other poorly controlled conditions as judged by the investigator (e.g., uncontrolled hypertension, diabetes, or arrhythmias). * Use of other investigational drugs within 14 days or 5 half-lives before treatment. * Steroid use over 10 mg/day prednisone equivalent within 14 days prior, except limited corticosteroid use with specific tapering guidelines; topical steroids allowed under conditions for CTCL. * Major surgery, radiotherapy, chemotherapy, or other anti-cancer treatments within 14 days or 5 half-lives before treatment. * Prior mogamulizumab use within six months before treatment; associated rash must be ruled out if \>6 months. * Known history of Grade ≥ 3 hypersensitivity to mogamulizumab. * Failure to recover from prior non-hematologic toxicities to Grade 0 or 1 (except alopecia and mild neuropathy). * Prolonged QT/QTc interval (e.g., QTcF \>480 ms). * Active second primary malignancies except specified non-exclusionary cases. * CNS involvement. * Any condition that may impair compliance or study completion as judged by the Investigator. * Known hypersensitivity to any excipients in the drug formulation.

Interventions

DRUG

KK2223

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Conditions

T-cell NHL (PTCL or CTCL)

Locations

City of Hope

Duarte, California 91010

United States

University of California, Irvine Medical Center - Hematology/Oncology

Orange, California 92868

United States

Stanford University School of Medicine

Stanford, California 94305

United States

Moffit Cancer Center

Tampa, Florida 33612

United States

Emory University Medical Center

Atlanta, Georgia 30322

United States

University of Iowa Health

Iowa City, Iowa 52242

United States

Beth Israel Deaconess Medical Center - Research

Boston, Massachusetts 02215

United States

Washington University School of Medicine - Oncology Hospital - Public

St Louis, Missouri 63110

United States

Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division

Hackensack, New Jersey 07601-2105

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021-6007

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania 19104

United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas 77030

United States

Istituto di Candiolo, IRCCS - Oncologia Medica ed Ematologia

Candiolo, Torino 10060

Italy

Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

Bergamo, 24127

Italy

Azienda Ospedaliero Universitaria di Bologna IRCCS (Policlinico di Sant'Orsola) - Ematologia

Bologna, 40138

Italy

AOU Citta' della Salute e della Scienza di Torino Ospedale Molinette, Ematologia Universitaria

Torino, 10126

Italy

Hospital Clinic De Barcelona - Hematología

Badalona, Barcelona 8036

Spain

Institut Català d'Oncologia (ICO) - ICO L'Hospitalet - Hematologia

L'Hospitalet de Llobregat, Barcelona 8907

Spain

Clinica Universidad de Navarra - Hematología

Pamplona, Navarre 31008

Spain

Clinica Universidad de Navarra - Hematología y Hemoterapia

Madrid, 28027

Spain