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KK2223 for Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma

This study is testing a new drug called KK2223 for adults with T-cell non-Hodgkin lymphoma (T-cell NHL) that has come back or hasn't responded to previous treatments. This includes peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). The main goals are to find out how safe KK2223 is, what side effects it might cause, and to determine the highest dose that can be given safely. You may be eligible if you are an adult (18 or older) with confirmed PTCL or CTCL that is relapsed or refractory. This is a "first-in-human" study, meaning it's one of the first times KK2223 is being given to people. The study plans to enroll 72 participants, but its current recruitment status is unclear.

Study design
This is a Phase 1, multicenter, open-label, non-randomized study with 72 planned participants. It includes a dose-escalation part and a backfill part.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 1.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07192471

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kyowa Kirin, Inc.
~72 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:KK2223

At a glance

Recruiting sites
4 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
Measured over Through study completion, an average of 1.5 years
+6 more outcomes measured

Conditions

T-cell NHL (PTCL or CTCL)

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NCT07192471

Where you'd take part

This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

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

    Torino, Italystudy coordinator listed

    Not yet recruiting

  • Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

    Bergamo, Italystudy coordinator listed

    Not yet recruiting

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

    Bologna, Italystudy coordinator listed

    Not yet recruiting

  • Beth Israel Deaconess Medical Center - Research

    Boston, Massachusettsstudy coordinator listed

    Not yet recruiting

  • City of Hope

    Duarte, Californiastudy coordinator listed

    Not yet recruiting

  • Clinica Universidad de Navarra - Hematología

    Pamplona, Navarre, Spainstudy coordinator listed

    Not yet recruiting

  • Clinica Universidad de Navarra - Hematología y Hemoterapia

    Madrid, Spainstudy coordinator listed

    Not yet recruiting

  • Emory University Medical Center

    Atlanta, Georgiastudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kyowa Kirin, Inc.
[email protected]
+1-609-919-1100
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Through study completion, an average of 1.5 years

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (all 72 potentially treated subjects)

  • Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Through study completion, an average of 1.5 years

    Vital signs (mmHg in Systolic/Diastolic blood pressure)

  • Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Through study completion, an average of 1.5 years

    Pulse rate (beats/min)

  • Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Through study completion, an average of 1.5 years

    Respiratory Rate (breath/min)

  • Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Through study completion, an average of 1.5 years

    Temperature (°Celcius)

  • Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Through study completion, an average of 1.5 years

    ECG parameters (PR interval, QRS interval, QT interval, QTc interval)

  • Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Through study completion, an average of 1.5 years

    Number of participants with dose-limiting toxicities (DLTs) in Part 1 only (at most 27 participants) and assess maximum tolerated dose (MTD)