Not Yet RecruitingPhase 1

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

United States, Italy, Spain72 participantsStarted 2026-07

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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. - Exclusion Criteria: * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since KK2223 is a first-in-human Phase 1 trial focused on finding the maximum tolerated dose, what does that mean practically for my safety — and how would side effects be monitored and managed if I were to participate?
2This trial isn't recruiting yet, so how long might it realistically be before it opens, and would waiting for it potentially affect my current treatment options or disease progression?
3My lymphoma is classified as T-cell NHL — does my specific subtype, whether it's PTCL or CTCL, make me a more or less likely candidate for this study once it does open?
4Given that this is the very first time KK2223 would be tested in humans, how does the unknowns about this drug compare to existing approved treatments for relapsed or refractory T-cell lymphoma that I might consider instead?
5What other standard or clinical trial options are available to me right now while this study is still in the pre-recruitment phase, so I'm not delaying treatment while waiting for it to open?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.