Non Hodgkin Lymphoma Clinical Trial

Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors

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.

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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).

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> 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
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening and C1D1 (pre-dose).
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.

Exclusion Criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05225584

Recruitment Status:

Recruiting

Sponsor:

Kymera Therapeutics, Inc.

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There are 9 Locations for this study

See Locations Near You

UC Irvine Health-Chao Family Comprehensive Cancer Center
Orange California, 92868, United States More Info
Lauren Pinter Brown, MD
Contact
877-827-8839
[email protected]
Norton Cancer Institute
Louisville Kentucky, 40207, United States More Info
Dana Haycraft
Contact
502-899-3366
[email protected]
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Cesar Figueras, MBA, HRM, BSN, RN
Contact
313-556-8731
[email protected]
Hackensack University Medical Center, John Theurer Cancer Center
Hackensack New Jersey, 07601, United States More Info
Elizabeth McCarthy, MSN, RN
Contact
412-860-6447
[email protected]
Montefiore Medical Center, The University Hospital for Albert Einstein College of Medicine
Bronx New York, 10467, United States More Info
Joel Victor
Contact
718-920-6680
[email protected]
The Christ Hospital Cancer Center
Cincinnati Ohio, 45219, United States More Info
Abby Reed
Contact
513-585-1140
[email protected]
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States More Info
Pierluigi Porcu, MD
Contact
215-586-0199
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Auris Huen, MD
Contact
713-745-1113
[email protected]
Oluwakemi Awolowo
Contact
713-745-1414
[email protected]
University of WA/Seattle Cancer Care Alliance
Seattle Washington, 98195, United States More Info
Stephen Smith, MD
Contact
206-606-6546
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05225584

Recruitment Status:

Recruiting

Sponsor:


Kymera Therapeutics, Inc.

How clear is this clinincal trial information?

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