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

NCT07192471 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 2223-001
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 15

Brief 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).

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

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  Through study completion, an average of 1.5 years

Secondary Outcomes (7)

• To evaluate the blood drug concentration

  Through study completion, an average of 1.5 years

• To evaluate the immunogenicity of KK2223.

  Through study completion, an average of 1.5 years

• To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).

  Through study completion, an average of 1.5 years

• To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).

  Through study completion, an average of 1.5 years

• To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).

  Through study completion, an average of 1.5 years

Study Arms (2)

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.

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.

Drug: KK2223

Interventions

KK2223 DRUG

Intravenous infusion

Part One (Dose Escalation); Part Two (Backfill)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and 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).
• 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. -

You may not qualify if:

• Recent autologous or allogeneic transplant within 120 days before treatment; active GVHD or ongoing immunosuppression after allogeneic transplant.
• Pregnant or breastfeeding females, or those intending pregnancy; males with partners intending pregnancy.
• History of HIV, HBV, or HCV infections generally excluded, except for controlled or resolved cases as defined.
• Uncontrolled infections requiring IV 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.
• 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.
• 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).
• CNS involvement.
• Any condition that may impair compliance or study completion as judged by the Investigator.-

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (15)

University of California, Irvine Medical Center - Hematology/Oncology

Orange, California, 92868, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Beth Israel Deaconess Medical Center - Research

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine - Oncology Hospital - Public

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division

Hackensack, New Jersey, 07601-2105, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021-6007, United States

Location

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Istituto di Candiolo, IRCCS - Oncologia Medica ed Ematologia

Candiolo, Torino, 10060, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

Bergamo, 24127, Italy

Location

Azienda Ospedaliero Universitaria di Bologna IRCCS (Policlinico di Sant'Orsola) - Ematologia

Bologna, 40138, Italy

Location

AOU Citta' della Salute e della Scienza di Torino Ospedale Molinette, Ematologia Universitaria

Torino, 10126, Italy

Location

Hospital Clinic De Barcelona - Hematología

Badalona, Barcelona, 8036, Spain

Location

Institut Català d'Oncologia (ICO) - ICO L'Hospitalet - Hematologia

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

Location

Clinica Universidad de Navarra - Hematología

Pamplona, Navarre, 31008, Spain

Location

Clinica Universidad de Navarra - Hematología y Hemoterapia

Madrid, 28027, Spain

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Neoplasms; Lymphoma; Immune System Diseases; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Sezary Syndrome

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Central Study Contacts

Kyowa Kirin, Inc.

CONTACT

+1-609-919-1100; KKD.Clinical.82@kyowakirin.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 25, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7); IT (4); ES (4)