New drug KK2223 enters early human testing for Tough-to-Treat T-Cell lymphoma

NCT ID NCT07192471

Disease control Sponsor: Kyowa Kirin, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This early-stage trial is testing an experimental drug called KK2223 in 72 adults with T-cell lymphoma (a type of blood cancer) that has returned or not responded to prior treatments. The main goals are to check the drug's safety, find the best dose, and see how the body processes it. The study is not yet recruiting and will take place at multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: KK2223 (an experimental drug given by IV infusion)
What this could lead to: If it works, this could point toward a new treatment option for people with T-cell lymphoma that has not responded to other therapies.
What could go wrong: This is a very early Phase 1 trial focused on safety and dosing, not on effectiveness. It is small (72 people) and may not lead to a proven treatment. Side effects are unknown.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

immune system disorder lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma mycosis fungoides neoplasm primary cutaneous T-cell non-Hodgkin lymphoma Sezary syndrome T-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

T-cell NHL (PTCL or CTCL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

22 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

Torino, 10126, Italy
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
NOT_YET_RECRUITING

Bergamo, 24127, Italy
Azienda Ospedaliero Universitaria di Bologna IRCCS (Policlinico di Sant'Orsola) - Ematologia
NOT_YET_RECRUITING

Bologna, 40138, Italy
Beth Israel Deaconess Medical Center - Research
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
City of Hope
NOT_YET_RECRUITING

Duarte, California, 91010, United States
Clinica Universidad de Navarra - Hematología
NOT_YET_RECRUITING

Pamplona, Navarre, 31008, Spain
Clinica Universidad de Navarra - Hematología y Hemoterapia
NOT_YET_RECRUITING

Madrid, 28027, Spain
Emory University Medical Center
NOT_YET_RECRUITING

Atlanta, Georgia, 30322, United States
Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division
NOT_YET_RECRUITING

Hackensack, New Jersey, 07601-2105, United States
Hospital Clinic De Barcelona - Hematología
NOT_YET_RECRUITING

Badalona, Barcelona, 8036, Spain
Institut Català d'Oncologia (ICO) - ICO L'Hospitalet - Hematologia
NOT_YET_RECRUITING

L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Istituto di Candiolo, IRCCS - Oncologia Medica ed Ematologia
NOT_YET_RECRUITING

Candiolo, Torino, 10060, Italy
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10021-6007, United States
Moffit Cancer Center
NOT_YET_RECRUITING

Tampa, Florida, 33612, United States
Oregon Health & Science University
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
Stanford University School of Medicine
RECRUITING

Stanford, California, 94305, United States
The University of Texas - MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING

Cleveland, Ohio, 44106, United States
University of California, Irvine Medical Center - Hematology/Oncology
NOT_YET_RECRUITING

Orange, California, 92868, United States
University of Iowa Health
NOT_YET_RECRUITING

Iowa City, Iowa, 52242, United States
University of Pennsylvania - Abramson Cancer Center
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Washington University School of Medicine - Oncology Hospital - Public
RECRUITING

St Louis, Missouri, 63110, United States