Clinical Trials in Italy / NCT07192471
Recruiting
Phase 1
A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin Lymphoma
NCT07192471 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
T-cell NHL (PTCL or CTCL)
Investigational drug(s) / intervention(s)
KK2223
KK2223: Intravenous infusion
Study 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).
Eligibility
Inclusion Criteria:
* 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 or 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).
* Body weight 40 kg to ≤ 200 kg
* 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. -
Exclusion Criteria:
* Recent autologous or allogeneic transplant within 120 days before treatment; active GVHD or ongoing immunosuppression after allogeneic transplant; prior HSCT and with active VOD/SOS
* Pregnant or breastfeeding females, or those intending pregnancy.
* History of HIV, HBV, or HCV infections generally excluded, except for controlled or resolved cases as defined.
* Uncontrolled infections requiring 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.
* Known history of Grade ≥ 3 hypersensitivity to mogamulizumab.
* 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).
* Active second primary malignancies except specified non-exclusionary cases.
* CNS involvement.
* Any condition that may impair compliance or study completion as judged by the Investigator.
* Known hypersensitivity to any excipients in the drug formulation.
Primary outcome measure(s)
- 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). — Through study completion, an average of 1.5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (all 72 potentially treated subjects) - 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). — Through study completion, an average of 1.5 years
Vital signs (mmHg in Systolic/Diastolic blood pressure) - 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). — Through study completion, an average of 1.5 years
Pulse rate (beats/min) - 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). — Through study completion, an average of 1.5 years
Respiratory Rate (breath/min) - 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). — Through study completion, an average of 1.5 years
Temperature (°Celcius) - 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). — Through study completion, an average of 1.5 years
ECG parameters (PR interval, QRS interval, QT interval, QTc interval) - 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). — Through study completion, an average of 1.5 years
Number of participants with dose-limiting toxicities (DLTs) in Part 1 only (at most 27 participants) and assess maximum tolerated dose (MTD)
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Not Yet Recruiting |
| University of California, Irvine Medical Center - Hematology/Oncology | Orange | California | Not Yet Recruiting |
| Stanford University School of Medicine | Stanford | California | Recruiting |
| Moffit Cancer Center | Tampa | Florida | Not Yet Recruiting |
| Emory University Medical Center | Atlanta | Georgia | Not Yet Recruiting |
| University of Iowa Health | Iowa City | Iowa | Not Yet Recruiting |
| Beth Israel Deaconess Medical Center - Research | Boston | Massachusetts | Not Yet Recruiting |
| Washington University School of Medicine - Oncology Hospital - Public | St Louis | Missouri | Recruiting |
| Hackensack University Medical Center - John Theurer Cancer C - Lymphoma Division | Hackensack | New Jersey | Not Yet Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Not Yet Recruiting |
| Oregon Health & Science University | Portland | Oregon | Not Yet Recruiting |
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | Not Yet Recruiting |
| The University of Texas - MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Istituto di Candiolo, IRCCS - Oncologia Medica ed Ematologia | Candiolo | Torino | Not Yet Recruiting |
| Azienda Ospedaliera Papa Giovanni XXIII - Ematologia | Bergamo | Italy | Not Yet Recruiting |
| Azienda Ospedaliero Universitaria di Bologna IRCCS (Policlinico di Sant'Orsola) - Ematologia | Bologna | Italy | Not Yet Recruiting |
| AOU Citta' della Salute e della Scienza di Torino Ospedale Molinette, Ematologia Universitaria | Torino | Italy | Not Yet Recruiting |
| Hospital Clinic De Barcelona - Hematología | Badalona | Barcelona | Not Yet Recruiting |
| Institut Català d'Oncologia (ICO) - ICO L'Hospitalet - Hematologia | L'Hospitalet de Llobregat | Barcelona | Not Yet Recruiting |
| Clinica Universidad de Navarra - Hematología | Pamplona | Navarre | Not Yet Recruiting |
| Clinica Universidad de Navarra - Hematología y Hemoterapia | Madrid | Spain | Not Yet Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07192471 on ClinicalTrials.gov ↗ ← All trials in Italy