Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Gra… (NCT05225584) | Clinical Trial Compass
CompletedPhase 1
Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors
United States56 participantsStarted 2022-05-19
Plain-language summary
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or Refractory (R/R) Lymphomas, Large Granular Lymphocytic Leukemia (LGL-L), T-cell prolymphocytic leukemia (T-PLL), and Solid Tumors. The Phase 1a stage of the study will explore escalating doses of single-agent KT-333. The Phase Ib stage will consist of 4 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Peripheral T-cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), LGL-L, and solid tumors.
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
. Phase 1a Only: Cytologically or pathologically confirmed Lymphomas (including Hodgkin's, B-cell, T-cell, Small Lymphocytic, or Natural-Killer (NK)-cell Lymphomas and LGL-L), T-PLL and solid tumors with the exception of chronic lymphocytic leukemia (CLL) Note: Patients with indolent non-Hodgkin's lymphoma (NHL) and small lymphocytic lymphoma (SLL) are only eligible if not require immediate cytoreductive therapy or if there are no available treatments with potential benefit.
. Phase 1b Only: Histologically or pathologically confirmed PTCL, CTCL, LGL-L \[T-cell LGL-L or Chronic Lymphoproliferative Disorder of NK-cells (CLPD-NK)\], or solid tumors.
. Fresh or archival formalin fixed paraffin embedded (FFPE) tumor tissue or 15 slides preferably collected within 6 months or 2 years prior to first dose of the study drug (for lymphoma and solid tumor patients respectively).
. Phase 1a only: Lymphoma and Solid Tumor: Relapsed and/or refractory disease to at least 2 prior systemic standard of care treatments or for whom standard therapies are not available.
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 KT-333 is a Phase 1 trial focused mainly on finding a safe dose and identifying serious side effects — not yet proving the drug works — how does that affect whether it might be a good fit for my situation compared to standard treatments?
2The trial is now completed, so actual safety data and dose-limiting toxicities have been collected — is my doctor aware of those results, and do any of the reported side effects concern them given my specific health history?
3My diagnosis falls under one of the conditions this trial studied, like peripheral T-cell lymphoma or large granular lymphocytic leukemia — based on what's now known from this study, does my doctor think KT-333 is moving toward later-phase trials that I might be eligible for?
4Because this was a Phase 1 study in patients with refractory disease — meaning cancer that stopped responding to prior treatments — does my doctor think I should try other available options first, or has my cancer already reached a point where an experimental approach makes more sense to explore?
5Are there any published or available results from this completed trial that my doctor has reviewed, particularly around which tumor types or diagnoses seemed to tolerate the drug best or showed any early signs of response?
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.
What they're measuring
1
Safety
Timeframe: Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
2
Safety
Timeframe: Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
3
Safety
Timeframe: Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
. Phase 1a: LGL-L/T-PLL only: Relapsed and/or refractory disease to at least 1 prior systemic standard of care treatment or for whom standard therapies are not available.
. Phase 1b only: All disease types: Relapsed and/or refractory disease to at least 1 prior systemic standard of care treatments or for whom standard therapies are not available.
. LGL-L patients only (hematology specific criteria):
. LGL-L Patients Only (baseline disease characteristics):
Exclusion criteria
. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
. Diagnosis of Chronic Lymphocytic Leukemia (CLL).
. History of or active concurrent malignancy other than lymphoma or solid tumors unless the patient has been disease-free for ≥ 2 years.
. Patient has not recovered from any clinically significant adverse events (AEs) of previous treatments to pretreatment baseline or Grade 1 prior to first dose of study drug.
. Ongoing unstable cardiovascular function.
. Autologous hematopoietic stem cell transplant less than 3 months prior to first dose of study drug.
. Prior allogenic hematopoietic or bone marrow transplant.