A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin Lymphoma
Part of paid clinical trials in Orange, California.
- Sponsor
- Kyowa Kirin, Inc.
- Study ID
- NCT07192471
- Phase
- PHASE1
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- T-cell NHL (PTCL or CTCL)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- KK2223 — DRUGIntravenous infusion
Study Details
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).
Key Dates
- Start date
- Jul 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2029
- Completion
- Sep 30, 2030
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
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.
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 ]
Central Contacts
- Kyowa Kirin, Inc.+1-609-919-1100
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Irvine Medical Center - Hematology/Oncology | Orange | California | 92868 | Lauren Pinter Brown (PRINCIPAL_INVESTIGATOR) |
| Stanford University School of Medicine | Stanford | California | 94305 | Youn Kim (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center - Research | Boston | Massachusetts | 02215 | Salvia Jain (PRINCIPAL_INVESTIGATOR) |
| Washington University School of Medicine - Oncology Hospital - Public | St Louis | Missouri | 63110 | Neha Mehta Shah (PRINCIPAL_INVESTIGATOR) |
| Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division | Hackensack | New Jersey | 07601-2105 | Tatyana Feldman (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021-6007 | Jasmine Zain (PRINCIPAL_INVESTIGATOR) |
| The University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | Ranjit Nair (PRINCIPAL_INVESTIGATOR) |