A Phase I First-in-Human Study to Evaluate the Safety and Pharmacokinetics of KK2223 in Patients with T-cell Non-Hodgkin Lymphoma
- Trial ID
- 2025-522523-96-00
- Protocol
- 2223-001
- Sponsor
- Kyowa Kirin Inc.
Trial statistics
Diseases & Conditions
Objectives
This first-in-human study evaluates the safety and tolerability of KK2223 in individuals diagnosed with T-cell Non-Hodgkin Lymphoma, including cutaneous T-cell lymphoma and peripheral T-cell lymphoma. The primary objective is to assess the safety profile of the investigated agent in this patient population. 4
Participants
This clinical trial involves a total of 38 patients. The study population includes both male and female individuals. The participants are diagnosed with T-cell non-Hodgkin lymphoma, which encompasses cutaneous T-cell lymphoma and peripheral T-cell lymphoma. The age range for the subjects is categorized under specific age codes 3 and 4.
Plans and Procedures
This is a Phase 1, first-in-human study evaluating the effects of KK2223 in individuals diagnosed with T-cell Non-Hodgkin Lymphoma, which includes cutaneous T-cell lymphoma and peripheral T-cell lymphoma. The clinical trial design involves a sequence of study visits beginning with a screening visit to assess eligibility. Subsequent follow-up visits are scheduled to monitor clinical progress and safety, concluding with an end-of-study visit. The total duration of the trial is estimated to span from August 2026 to May 2031. Participation may be terminated prematurely if specific clinical conditions or safety criteria are met.
Treatment
Efficacy
The clinical trial focuses on evaluating efficacy in subjects with T-cell Non-Hodgkin Lymphoma, Cutaneous T-cell lymphoma, and Peripheral T-cell lymphoma.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Italy | Not Yet Recruiting | 27 Aug 2026 | 17 |
Spain | Not Yet Recruiting | 27 Aug 2026 | 17 |


