T-cell NHL (PTCL or CTCL)Phase 1NCT07192471
A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin Lymphoma
A Phase 1 study testing KK2223 in people with T-cell NHL (PTCL or CTCL), run by Kyowa Kirin, Inc. at 22 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell NHL (PTCL or CTCL)
- What is being tested?
- KK2223
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 2 Sep 2026to Sep 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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. -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 3 countries
United States14 sites, 14 recruiting
- Not yet recruiting
Emory University Medical Center
Atlanta, Georgia, 30322
Pamela Allen, 404-778-2407, pallen5@emory.edu
Pamela Allen
- Not yet recruiting
Beth Israel Deaconess Medical Center - Research
Boston, Massachusetts, 02215
Salvia Jain, 617-726-2000, salvia.jain@mgh.harvard.edu
Salvia Jain
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Kevin Cooper, 216-844-8200, kevin.cooper@uhhospitals.org
Kevin Cooper
- Not yet recruiting
City of Hope
Duarte, California, 91010
Christina Poh, 916-734-7131, cpoh@coh.org
Christina Poh
- Not yet recruiting
Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division
Hackensack, New Jersey, 07601-2105
Tatyana Feldman, 551-996-5900, tatyana.feldman@hmhn.org
Tatyana Feldman
- Recruiting
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Ranjit Nair, 171-379-2860, rnair@mdanderson.org
Ranjit Nair
- Not yet recruiting
University of Iowa Health
Iowa City, Iowa, 52242
Eric Mou, 800-777-8442, eric-mou@uiowa.edu
Eric Mou
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021-6007
Jasmine Zain, 212-639-3045, zainj1@mskcc.org
Jasmine Zain
- Not yet recruiting
University of California, Irvine Medical Center - Hematology/Oncology
Orange, California, 92868
Lauren Pinter Brown, 7144568200, lpinterb@uci.edu
Lauren Pinter Brown
- Not yet recruiting
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Stefan Barta, 215-728-2674, Stefan.Barta@pennmedicine.upenn.edu
Stefan Barta
- Not yet recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Craig Okada, 503-494-8397, okadac@ohsu.edu
Craig Okada
- Recruiting
Washington University School of Medicine - Oncology Hospital - Public
St Louis, Missouri, 63110
Neha Mehta Shah, 314.273-8566, mehta-n@wustl.edu
Neha Mehta Shah
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Youn Kim, 650-723-7893, younkim@stanford.edu
Youn Kim
- Not yet recruiting
Moffit Cancer Center
Tampa, Florida, 33612
Yumeng Zhang, 844-304-8636, yumeng.zhang@moffitt.org
Yumeng Zhang
Italy4 sites, 4 recruiting
- Not yet recruiting
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
Bergamo, 24127
Giuseppe Gritti, 39035269492, giuseppe_gritti@yahoo.it
Giuseppe Gritti
- Not yet recruiting
Azienda Ospedaliero Universitaria di Bologna IRCCS (Policlinico di Sant'Orsola) - Ematologia
Bologna, 40138
Luigi Zinzani Pier, 390516363680, pierluigi.zinzani@unibo.it
Luigi Zinzani Pier
- Not yet recruiting
Istituto di Candiolo, IRCCS - Oncologia Medica ed Ematologia
Candiolo, Torino, 10060
Umberto Vitolo, 390116335934, umberto.vitolo@ircc.it
Umberto Vitolo
- Not yet recruiting
AOU Citta' della Salute e della Scienza di Torino Ospedale Molinette, Ematologia Universitaria
Torino, 10126
Federica Cavallo, 390116334264, f.cavallo@unito.it
Federica Cavallo
Spain4 sites, 4 recruiting
- Not yet recruiting
Hospital Clinic De Barcelona - Hematología
Badalona, Barcelona, 8036
Pablo Mozas, 34 93 227 22 71, mozas@clinic.cat
Pablo Mozas
- Not yet recruiting
Institut Català d'Oncologia (ICO) - ICO L'Hospitalet - Hematologia
L'Hospitalet de Llobregat, Barcelona, 8907
Eva Domingo Domenech, 34932607822, edomingo@iconcologia.net
Eva Domingo Domenech
- Not yet recruiting
Clinica Universidad de Navarra - Hematología y Hemoterapia
Madrid, 28027
Miguel Canales Albendea, 34917277116, macanales@unav.es
Migue Canales Albendea
- Not yet recruiting
Clinica Universidad de Navarra - Hematología
Pamplona, Navarre, 31008
Miguel Canales Albendea, 34917277116, macanales@unav.es
Miguel Canales Albendea
About this study
Official title: 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).
Read the 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)
- Conditions
- T-cell NHL (PTCL or CTCL)
- Being tested
- KK2223
- Keywords
- Neoplasms, Lymphoma, Immune System Diseases, First in Human, Lymphoma, T-Cell, Cutaneous +, Lymphoma, T-Cell, Peripheral, Mycosis fungoides, Sezary Syndrome
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Neoplasms, Lymphoma, Immune System Diseases, Lymphoma, T-Cell, Peripheral, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KK2223Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part One (Dose Escalation) | Experimental | In Part 1, safety and tolerability of KK2223 in relapsed/refractory PTCL or CTCL patients will be assessed using a BOIN dose-escalation design. Receives: Drug: KK2223 |
| Part Two (Backfill) | Experimental | 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. Receives: Drug: KK2223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (all 72 potentially treated subjects)
Measured: 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).
Vital signs (mmHg in Systolic/Diastolic blood pressure)
Measured: 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).
Pulse rate (beats/min)
Measured: 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).
Respiratory Rate (breath/min)
Measured: 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).
Temperature (°Celcius)
Measured: 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).
ECG parameters (PR interval, QRS interval, QT interval, QTc interval)
Measured: 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).
Number of participants with dose-limiting toxicities (DLTs) in Part 1 only (at most 27 participants) and assess maximum tolerated dose (MTD)
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (13)
Mean Blood Drug Concentration
The mean drug concentration in the blood
Measured: Through study completion, an average of 1.5 years
To evaluate the immunogenicity of KK2223.
Incidence of Anti drug antibodies (ADA) in blood
Measured: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
% in Overall Response Rate (ORR)
Measured: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
% in Compartment Response (if applicable)
Measured: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time unit (week/month) in Duration of Response (DOR)
Measured: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time unit (week/month) in Time To Next Treatment (TTNT) will be evaluated
Measured: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time unit (week/month) in Time To Response (TTR)
Measured: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Maximum Blood Concentration (Cmax)
The maximum drug concentration
Measured: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC)
A measure of the overall drug exposure over time
Measured: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
The time taken to reach the maximum drug concentration
Measured: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Terminal Half-Life (Thalf)
The time required for the drug concentration to decrease by 50%
Measured: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Clearance (CL)
Rate of drug elimination from the body
Measured: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss)
Theoretical volume of distribution at steady state and reflects the extent of drug istribution into tissues
Measured: Through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start2 Sep 2026
- Primary completionMar 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell NHL (PTCL or CTCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a sequential design study where participants receive interventions in a stepwise manner. Treatment assignments and doses may be adjusted based on interim safety and efficacy analyses conducted throughout the trial.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192471
- Sponsor's protocol ID
- 2223-001
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07192471
- Acronym / sponsor ID
- 2223-001
- Conditions
- T-cell NHL (PTCL or CTCL)
- Keywords
- Neoplasms, Lymphoma, Immune System Diseases, First in Human, Lymphoma, T-Cell, Cutaneous +, Lymphoma, T-Cell, Peripheral, Mycosis fungoides, Sezary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a sequential design study where participants receive interventions in a stepwise manner. Treatment assignments and doses may be adjusted based on interim safety and efficacy analyses conducted throughout the trial.
| Arm | Type | Receives |
|---|---|---|
| Part One (Dose Escalation) | Experimental | Drug: KK2223In Part 1, safety and tolerability of KK2223 in relapsed/refractory PTCL or CTCL patients will be assessed using a BOIN dose-escalation design. |
| Part Two (Backfill) | Experimental | Drug: KK2223Part 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KK2223Intravenous infusion | Drug | Part One (Dose Escalation), Part Two (Backfill) |
Primary outcome
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)
13 secondary outcomes
Mean Blood Drug Concentration
Time frame: Through study completion, an average of 1.5 years
To evaluate the immunogenicity of KK2223.
Time frame: 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
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time frame: 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
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time frame: 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
Pharmacokinetic Parameter Maximum Blood Concentration (Cmax)
Time frame: 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
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Time frame: 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
Pharmacokinetic Parameter Clearance (CL)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KK2223 in people with T-cell NHL (PTCL or CTCL), run by Kyowa Kirin, Inc. at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyowa Kirin, Inc. (+1-609-919-1100, KKD.Clinical.82@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.