Recruiting
Phase 1

KK2223

Sponsor:

Kyowa Kirin, Inc.

Code:

NCT07192471

Conditions

T-cell NHL (PTCL or CTCL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KK2223

Study Details

Brief 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).

Conditions

T-cell NHL (PTCL or CTCL)

Study ID

NCT07192471

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part One (Dose Escalation)

In Part 1, safety and tolerability of KK2223 in relapsed/refractory PTCL or CTCL patients will be assessed using a BOIN dose-escalation design.

experimental: Part Two (Backfill)

Part 2 will collect additional data, with dose levels and cohort size based on Part 1 results, administering doses approved for tolerability. Backfill cohorts at cleared doses may open, prioritizing Part 1 enrollment.

Interventions

KK2223

Intravenous infusion

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Kyowa Kirin, Inc.

+1-609-919-1100KKD.Clinical.82@kyowakirin.com

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Youn Kim

650-723-7893younkim@stanford.edu

Principal Investigator:

Youn Kim

Washington University School of Medicine - Oncology Hospital - Public

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Neha Mehta Shah

314.273-8566mehta-n@wustl.edu

Principal Investigator:

Neha Mehta Shah

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021-6007

Contacts

Jasmine Zain

212-639-3045zainj1@mskcc.org

Principal Investigator:

Jasmine Zain

The University of Texas - MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ranjit Nair

171-379-2860rnair@mdanderson.org

Principal Investigator:

Ranjit Nair

More Information

Sponsor

Kyowa Kirin, Inc.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Neoplasms
  • Lymphoma
  • Immune System Diseases
  • First in Human
  • Lymphoma, T-Cell, Cutaneous +
  • Lymphoma, T-Cell, Peripheral
  • Mycosis fungoides
  • Sezary Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kyowa Kirin, Inc. on 2026-08-21.