Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors
a study on Hodgkin's Lymphoma Lymphoma Non-Hodgkin Lymphoma T Cell Lymphoma Cutaneous T-Cell Lymphoma Leukemia Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedestimated completion
Description
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 Lymphomas, Large Granular Lymphocytic Leukemia, 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), Large Granular Lymphocytic Leukemia (LGL-L), and solid tumors.
Official Title
A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-333 in Adult Patients With Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and Solid Tumors
Details
This is an open-label Phase 1a (dose escalation)/1b (dose expansion) first-in-human study of KT-333 in adult patients. Patients with relapsed/refractory (R/R) lymphomas, LGL-L and solid tumors will be enrolled in Phase 1a. Phase 1b will consist of separate cohorts of patients with R/R PTCL, CTCL, LGL-L, and solid tumors.
Keywords
Non Hodgkin Lymphoma (NHL), Peripheral T-cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Large Granular Lymphocytic Leukemia (LGL-L), Solid Tumors, Lymphoma, Leukemia, Non-Hodgkin Lymphoma, Lymphoid Leukemia, T-Cell Lymphoma, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Large Granular Lymphocytic Leukemia
Eligibility
You can join if…
Open to people ages 18 years and up
- Phase 1a Only: Histologically or pathologically confirmed Lymphomas (including Hodgkin's, B-cell, T-cell, Small Lymphocytic, or NK-cell Lymphomas and LGL-L) and solid tumors with the exception of chronic lymphocytic leukemia (CLL) Note: Patients with indolent 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: 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):
- One of the following:
- Severe neutropenia < 500/mm3, or,
- Symptomatic anemia and/or,
- Transfusion-dependent anemia.
- ANC ≥ 200/μL at Screening and C1D1 (pre dose)
- Platelet count ≥ 100,000/μL (assessed ≥ 7 days following last platelet transfusion in patients with thrombocytopenia requiring platelets).
- One of the following:
- LGL-L Patients Only (baseline disease characteristics):
- CD3+CD8+ cell population >650/mm3;
- CD3+CD8+CD57+ population >500/mm3;
- Presence of a clonal T-cell receptor (within 1 month of diagnosis);
- Note: patients with T-LGLL may be included with PI approval even if CD3+CD8+ cell population is<650/mm3 or CD3+CD8+CD57+ population is <500/mm3, though +TCR is required;
- Natural-Killer (NK) LGL is also permitted, provided there is a clonal NK-cell population noted with>500 cells/mm3
PTCL and solid tumors Only: Measurable disease at Screening. Solid tumor patients with non-measurable disease are allowed in Phase1a
10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening and
C1D1 (pre-dose).
11. Adequate bone marrow function at Screening and C1D1 (pre-dose) for all patients except
those with LGL-L Adequate liver/kidney organ function at Screening and C1D1 (pre-dose) for all patients. Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive methods for the duration of study treatment and 6 months after the last dose of KT333.
You CAN'T join if...
- History or suspicion of central nervous system (CNS) metastases.
- 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.
Locations
- UC Irvine Health-Chao Family Comprehensive Cancer Center
accepting new patients
Orange California 92868-3201 United States - University of WA/Seattle Cancer Care Alliance
accepting new patients
Seattle Washington 98195 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Kymera Therapeutics, Inc.
- ID
- NCT05225584
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 120 study participants
- Last Updated
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