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

August 19, 2026 updated by: Kyowa Kirin, Inc.

A Phase 1, Multicenter, Open-label, Non-randomized, Dose-escalation and Backfill Study of KK2223 in Participants With Relapsed or Refractory T-cell Non Hodgkin Lymphoma

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
        • Principal Investigator:
          • Giuseppe Gritti
        • Contact:
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria di Bologna IRCCS (Policlinico di Sant'Orsola) - Ematologia
        • Contact:
        • Principal Investigator:
          • Luigi Zinzani Pier
      • Torino, Italy, 10126
        • Not yet recruiting
        • AOU Citta' della Salute e della Scienza di Torino Ospedale Molinette, Ematologia Universitaria
        • Contact:
        • Principal Investigator:
          • Federica Cavallo
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Not yet recruiting
        • Istituto di Candiolo, IRCCS - Oncologia Medica ed Ematologia
        • Principal Investigator:
          • Umberto Vitolo
        • Contact:
  • Spain
      • Madrid, Spain, 28027
        • Not yet recruiting
        • Clinica Universidad de Navarra - Hematología y Hemoterapia
        • Contact:
        • Principal Investigator:
          • Migue Canales Albendea
    • Barcelona
      • Badalona, Barcelona, Spain, 8036
        • Not yet recruiting
        • Hospital Clinic De Barcelona - Hematología
        • Principal Investigator:
          • Pablo Mozas
        • Contact:
      • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
        • Not yet recruiting
        • Institut Català d'Oncologia (ICO) - ICO L'Hospitalet - Hematologia
        • Principal Investigator:
          • Eva Domingo Domenech
        • Contact:
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Not yet recruiting
        • Clinica Universidad de Navarra - Hematología
        • Contact:
        • Principal Investigator:
          • Miguel Canales Albendea
  • United States
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope
        • Principal Investigator:
          • Christina Poh
        • Contact:
          • Christina Poh
          • Phone Number: 916-734-7131
          • Email: cpoh@coh.org
      • Orange, California, United States, 92868
        • Not yet recruiting
        • University of California, Irvine Medical Center - Hematology/Oncology
        • Contact:
        • Principal Investigator:
          • Lauren Pinter Brown
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Principal Investigator:
          • Youn Kim
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Moffit Cancer center
        • Contact:
        • Principal Investigator:
          • Yumeng Zhang
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Emory University Medical Center
        • Principal Investigator:
          • Pamela Allen
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa Health
        • Principal Investigator:
          • Eric Mou
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center - Research
        • Contact:
        • Principal Investigator:
          • Salvia Jain
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Oncology Hospital - Public
        • Principal Investigator:
          • Neha Mehta Shah
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-2105
        • Not yet recruiting
        • Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division
        • Principal Investigator:
          • Tatyana Feldman
        • Contact:
    • New York
      • New York, New York, United States, 10021-6007
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Jasmine Zain
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Kevin Cooper
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Craig Okada
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania - Abramson Cancer Center
        • Principal Investigator:
          • Stefan Barta
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas - MD Anderson Cancer Center
        • Principal Investigator:
          • Ranjit Nair
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: KK2223
Intravenous infusion
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.
Drug: KK2223
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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
Vital signs (mmHg in Systolic/Diastolic blood pressure)
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
Pulse rate (beats/min)
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
Respiratory Rate (breath/min)
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
Temperature (°Celcius)
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
ECG parameters (PR interval, QRS interval, QT interval, QTc interval)
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
Number of participants with dose-limiting toxicities (DLTs) in Part 1 only (at most 27 participants) and assess maximum tolerated dose (MTD)
Through study completion, an average of 1.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the immunogenicity of KK2223.
Time Frame: Through study completion, an average of 1.5 years
Incidence of Anti drug antibodies (ADA) in blood
Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time Frame: Through study completion, an average of 1.5 years
% in Overall Response Rate (ORR)
Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time Frame: Through study completion, an average of 1.5 years
% in Compartment Response (if applicable)
Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time Frame: Through study completion, an average of 1.5 years
Time unit (week/month) in Duration of Response (DOR)
Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time Frame: Through study completion, an average of 1.5 years
Time unit (week/month) in Time To Next Treatment (TTNT) will be evaluated
Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time Frame: Through study completion, an average of 1.5 years
Time unit (week/month) in Time To Response (TTR)
Through study completion, an average of 1.5 years
Mean Blood Drug Concentration
Time Frame: Through study completion, an average of 1.5 years
The mean drug concentration in the blood
Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Maximum Blood Concentration (Cmax)
Time Frame: Through study completion, an average of 1.5 years
The maximum drug concentration
Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC)
Time Frame: Through study completion, an average of 1.5 years
A measure of the overall drug exposure over time
Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Time Frame: Through study completion, an average of 1.5 years
The time taken to reach the maximum drug concentration
Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Terminal Half-Life (Thalf)
Time Frame: Through study completion, an average of 1.5 years
The time required for the drug concentration to decrease by 50%
Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Clearance (CL)
Time Frame: Through study completion, an average of 1.5 years
Rate of drug elimination from the body
Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss)
Time Frame: Through study completion, an average of 1.5 years
Theoretical volume of distribution at steady state and reflects the extent of drug istribution into tissues
Through study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyowa Kirin, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2223-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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