NCT07192471 · Kyowa Kirin, Inc.
A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin Lymphoma
What this study is about
The purpose of this study is to determine the safety, tolerability, PK and how the drug affects the body of KK2223 in adult participants with relapsed or refractory peripheral T cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL).
View original scientific description
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).
Interventions
DRUG
KK2223
Intravenous infusion
Primary outcome 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Duarte, California
- Orange, California
- Stanford, California
- Tampa, Florida
- Atlanta, Georgia
- Iowa City, Iowa
- Boston, Massachusetts
- St Louis, Missouri
- Hackensack, New Jersey
- New York, New York
- Cleveland, Ohio
- Portland, Oregon
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations