What side effects are associated with this type of intervention?

Common treatments for Prolymphocytic Leukemia (PLL) include chemotherapy, monoclonal antibodies, and investigational drugs like KT-333. Known side effects of these treatments can include cytopenias (such as thrombocytopenia and neutropenia), mucocutaneous ulcers, gastrointestinal disturbances (diarrhea, nausea), peripheral neuropathy, and potential liver toxicity (elevated transaminases). Additionally, there may be risks of infections due to immunosuppression, and in some cases, severe toxicities like pulmonary toxicity or cardiovascular events (e.g., myocardial infarction) have been reported.

What prior FDA approvals exist?

There are no specific FDA-approved treatments exclusively for Prolymphocytic Leukemia (PLL). However, treatments for PLL often utilize regimens approved for chronic lymphocytic leukemia (CLL), such as fludarabine, cyclophosphamide, and rituximab. Additionally, investigational therapies like chimeric antigen receptor (CAR) T-cell therapy are being explored. KT-333, an investigational drug, is being studied for its safety and pharmacokinetics in refractory lymphomas and leukemias, which may offer insights into future treatment options for PLL.

What other types of research exist?

Promising novel alternatives to KT-333 for Prolymphocytic Leukemia (T-PLL) patients include: 1) Small molecule tyrosine kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib, which have shown limited activity in advanced osteosarcoma and may have potential in T-PLL. 2) Homoharringtonine and omacetaxine, which have shown efficacy in myeloid hematological malignancies and could be considered for T-PLL. 3) Investigational treatments involving interferon, hydroxychloroquine, BCL6 inhibitors, and smoothened antagonists like LDF225 and BMS-833923, which are being explored for other resistant hematological conditions and may offer potential benefits for T-PLL.

← Back to Search

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

Select...

I can care for myself and am up and about more than 50% of my waking hours.

Select...

My liver and kidneys are working well.

Select...

I have T-PLL with measurable disease or atypical T cells in my blood or bone marrow.

Select...

My cancer can be measured by tests.

Select...

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:

Select...

I had a stem cell transplant using my own cells less than 3 months ago.

Select...

I do not have active, uncontrolled brain metastases or specific types of meningitis.

Select...

My heart condition is currently unstable.

Select...

I have been diagnosed with Chronic Lymphocytic Leukemia.

Timeline

Screening ~ 3 weeks3 visits

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

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.