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 range18 Years
SexALL
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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.
✓. 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.
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
. 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.