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Virus Therapy

KT-333 for Lymphoma and Cancer

Phase 1
Recruiting
Research Sponsored by Kymera Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening and C1D1 (pre-dose)
Patients with adequate liver/kidney organ function at Screening and C1D1 (pre-dose)
Must not have
Patients who had autologous hematopoietic stem cell transplant less than 3 months prior to the first dose of the study drug
Patients with known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first of response to the date of documented first progression or death whichever comes first, about 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called KT-333 in adults with certain cancers that haven't responded to other treatments. The goal is to see if the drug is safe and how it works in the body.

Who is the study for?
Adults with certain types of blood cancers or solid tumors that haven't responded to standard treatments can join this trial. They should have a specific level of white blood cells, be in fair health (ECOG 0-2), and women must use effective birth control. People with brain metastases, another active cancer besides lymphoma or solid tumors, recent transplants, or unresolved treatment side effects are excluded.
What is being tested?
The study is testing KT-333's safety and how the body processes it in two phases: Phase 1a tests increasing doses on various cancers; Phase 1b focuses on Peripheral T-cell Lymphoma, Cutaneous T-Cell Lymphoma, Large Granular Lymphocytic Leukemia, and solid tumors to further understand KT-333's effects.
What are the potential side effects?
While the specific side effects for KT-333 aren't listed here, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver/kidney issues from organ inflammation. Patients will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself and am up and about more than 50% of my waking hours.
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My liver and kidneys are working well.
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I have T-PLL with measurable disease or atypical T cells in my blood or bone marrow.
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My cancer can be measured by tests.
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I have LGL leukemia with severe low white blood cell count, significant tiredness due to low red blood cell count, or need regular blood transfusions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a stem cell transplant using my own cells less than 3 months ago.
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I do not have active, uncontrolled brain metastases or specific types of meningitis.
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My heart condition is currently unstable.
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I have been diagnosed with Chronic Lymphocytic Leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first of response to the date of documented first progression or death whichever comes first, about 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first of response to the date of documented first progression or death whichever comes first, about 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicities (DLTs)
Maximum Tolerated Dose (MTD)
Safety
Secondary study objectives
Amount of KT-333 dose excreted in urine from time zero to last collected time point (Ae0-t)
Area under the plasma concentration versus time curve for KT-333
Duration of Response (DOR)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Phase 1b Dose Expansion Solid TumorExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles
Group II: Phase 1b Dose Expansion PTCLExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles
Group III: Phase 1b Dose Expansion LGL-LExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles
Group IV: Phase 1b Dose Expansion CTCLExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles
Group V: Phase 1a Dose Escalation T-PLLExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles
Group VI: Phase 1a Dose Escalation Solid TumorsExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles
Group VII: Phase 1a Dose Escalation LymphomasExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles
Group VIII: Phase 1a Dose Escalation LGL-LExperimental Treatment1 Intervention
KT-333 dosed IV weekly in 28 day cycles

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prolymphocytic Leukemia (PLL) is commonly treated with agents such as purine analogs (e.g., fludarabine), monoclonal antibodies (e.g., alemtuzumab), and targeted therapies (e.g., ibrutinib). Purine analogs work by interfering with DNA synthesis, leading to cell death. Monoclonal antibodies target specific antigens on the surface of leukemia cells, marking them for destruction by the immune system. Targeted therapies, like ibrutinib, inhibit specific signaling pathways crucial for leukemia cell survival and proliferation. Investigational drugs like KT-333, which focus on safety, tolerability, and pharmacokinetics/pharmacodynamics, aim to optimize these mechanisms to improve efficacy and reduce toxicity. Understanding these mechanisms is crucial for PLL patients as it helps in selecting the most effective treatment with the least side effects, potentially improving outcomes and quality of life.
The effect of eltrombopag in managing thrombocytopenia associated with tyrosine kinase therapy in patients with chronic myeloid leukemia and myelofibrosis.A novel BH3-mimetic, AZD0466, targeting BCL-XL and BCL-2 is effective in pre-clinical models of malignant pleural mesothelioma.Optimal use of thrombopoietin receptor agonists in immune thrombocytopenia.

Find a Location

Who is running the clinical trial?

Kymera Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
558 Total Patients Enrolled
Ashwin Gollerkeri, MDStudy DirectorKymera Therapeutics, Inc.
4 Previous Clinical Trials
304 Total Patients Enrolled

Media Library

KT-333 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05225584 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Phase 1a Dose Escalation Lymphomas, Phase 1a Dose Escalation Solid Tumors, Phase 1b Dose Expansion PTCL, Phase 1b Dose Expansion CTCL, Phase 1b Dose Expansion LGL-L, Phase 1b Dose Expansion Solid Tumor, Phase 1a Dose Escalation LGL-L, Phase 1a Dose Escalation T-PLL
Non-Hodgkin's Lymphoma Clinical Trial 2023: KT-333 Highlights & Side Effects. Trial Name: NCT05225584 — Phase 1
KT-333 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225584 — Phase 1
~11 spots leftby Feb 2025