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Phase 1Not yet recruitingPriority 4 · Lower priorityNCT07192471

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

ClinicalTrials.gov

Plain-language summary

This trial is testing KK2223 for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome whose disease has come back or stopped responding to prior treatment. This is a Phase 1 trial, which means researchers are finding the right dose and this is among the earliest testing in patients. Patients are randomly assigned to different treatment groups. This trial is available at 9 locations in the United States. The trial is not yet open for recruitment.

Who can join (key eligibility)

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

KK2223 (DRUG): Intravenous infusion

  • KK2223

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

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TrialCompass — Clinical Trial Summary

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

NCT07192471

Phase: Phase 1 | Status: Not yet recruiting | Priority: Lower

Plain-language summary

This trial is testing KK2223 for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome whose disease has come back or stopped responding to prior treatment. This is a Phase 1 trial, which means researchers are finding the right dose and this is among the earliest testing in patients. Patients are randomly assigned to different treatment groups. This trial is available at 9 locations in the United States. The trial is not yet open for recruitment.

Who can join

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

KK2223 (DRUG): Intravenous infusion

Drugs / treatments: KK2223

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 72 patients

Primary endpoint: 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).; 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).; 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).; 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).; 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).; 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).; 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).

Ages: 18 Years to —

Start date: 2026-08 | Est. completion: 2030-09

Locations

9 US sites · 17 total

California, Massachusetts, Missouri, New Jersey, New York, Oregon, Pennsylvania, Texas

Contact

Kyowa Kirin, Inc. | KKD.Clinical.82@kyowakirin.com | +1-609-919-1100

Sponsor: Kyowa Kirin, Inc. (INDUSTRY)

Tags

CTCL · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07192471

Prepared using TrialCompass (trialcompass.com) on August 3, 2026. For informational purposes only. Always discuss with your healthcare team.