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

Conditions

• T-cell NHL (PTCL or CTCL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• KK2223 — DRUG
  Intravenous 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

First listed

Sep 25, 2025

Start date

Sep 30, 2026

Status verified

Aug 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
  [email protected]

Locations (14)

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