What side effects are associated with this type of intervention?

Common cancer treatments include chemotherapy, radiation therapy, immunotherapy, and targeted therapy. Chemotherapy often causes side effects such as nausea, vomiting, hair loss, and peripheral neuropathy. Radiation therapy can lead to skin reactions, fatigue, and pneumonitis. Immunotherapy, including treatments like nivolumab and ipilimumab, may cause skin reactions, endocrine issues, and pneumonitis. Targeted therapies can result in diarrhea, liver problems, and skin issues. For treatments similar to allogeneic NK cells, potential side effects may include infusion reactions, fever, chills, and fatigue, although specific data on NK cell therapy side effects is limited.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of various cancers. For instance, ipilimumab and pembrolizumab are approved for advanced melanoma, targeting immune checkpoints to enhance the body's immune response against cancer cells. Additionally, nivolumab has been approved for esophageal squamous cell carcinoma. While specific FDA approvals for allogeneic NK cell therapies like SNK02 are not mentioned, the focus on immunotherapy highlights the ongoing advancements in leveraging the immune system to combat cancer.

What other types of research exist?

Promising novel alternatives to SNK02 for cancer patients in 2024 include: 1) CAR T-cell therapy, particularly for hematologic malignancies, 2) Immune checkpoint inhibitors such as nivolumab and pembrolizumab, which target PD-1/PD-L1 pathways, 3) Bispecific T-cell engagers (BiTEs) like blinatumomab, 4) Oncolytic virus therapy, which uses genetically modified viruses to target cancer cells, and 5) Personalized cancer vaccines that stimulate the immune system to attack specific tumor antigens.

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CAR T-cell Therapy

NK Cells (SNK02) for Refractory Cancer

Phase 1

Waitlist Available

Research Sponsored by NKGen Biotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing SNK02, a treatment using donor immune cells, in cancer patients who haven't responded to standard treatments. The goal is to see if it is safe and to find the best dose. The treatment works by using special immune cells to help the body fight cancer. SNK02 is a type of natural killer (NK) cell therapy, which has been explored in various clinical trials for its potential to treat multiple malignancies, especially acute myelogenous leukemia.

Who is the study for?

This trial is for adults with advanced cancers that haven't responded to standard treatments. They should be relatively healthy otherwise, with good liver, kidney, and bone marrow function, not pregnant or breastfeeding, able to use birth control if needed, and have no severe heart issues or autoimmune diseases requiring strong medication.

What is being tested?

The study tests SNK02—a treatment involving natural killer (NK) cells given through an IV once a week for two months. It aims to find out how safe it is and the highest dose patients can take without serious side effects.

What are the potential side effects?

While specific side effects of SNK02 are being studied in this trial and aren't fully known yet, similar therapies often cause flu-like symptoms such as fever and chills, fatigue, headache, nausea or vomiting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD and/or RP2D

Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cohort 1Experimental Treatment1 Intervention

SNK02 will be administered as an IV infusion weekly for 8 weeks.

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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

Common cancer treatments include chemotherapy, radiation therapy, targeted therapy, and immunotherapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while radiation therapy uses high-energy particles to damage DNA in cancer cells. Targeted therapy involves drugs that specifically target molecular pathways critical for cancer cell survival and proliferation. Immunotherapy, including treatments like allogeneic NK cells, harnesses the body's immune system to recognize and destroy cancer cells. These mechanisms are crucial for cancer patients as they offer different strategies to combat cancer, potentially leading to more effective and personalized treatment options.

Current therapeutic strategies for acute myeloid leukaemia.