PD-L1 t-haNK for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called PD-L1 t-haNK, a type of immunotherapy using modified natural killer cells, for individuals with advanced solid cancers that have spread or are difficult to remove. The main goals are to assess the treatment's safety, effectiveness, and to determine the optimal dose for future studies. Participants should have a solid tumor cancer that has not responded to previous treatments or have no other effective treatment options. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic daily treatment with systemic corticosteroids, you may need to stop, as this is listed as an exclusion criterion.
Is there any evidence suggesting that PD-L1 t-haNK is likely to be safe for humans?
Research has shown that PD-L1 t-haNK, a therapy using natural killer (NK) cells, has been tested in earlier studies. These studies found no serious side effects that would prevent doctors from increasing the dose, indicating the treatment is generally safe for patients. The therapy uses NK cells to attack cancer cells, and early results are positive for safety. This information is reassuring for anyone considering joining a clinical trial for PD-L1 t-haNK.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about PD-L1 t-haNK for advanced cancer because it leverages a novel approach using engineered natural killer (NK) cells to target cancer cells. Unlike traditional treatments for advanced solid cancers, such as chemotherapy or PD-1/PD-L1 inhibitors that rely on directly damaging cancer cells or blocking immune checkpoints, PD-L1 t-haNK harnesses the body's immune system by enhancing NK cells to recognize and attack tumors. This unique mechanism of action provides a promising alternative for patients, potentially offering more targeted and effective treatment with fewer side effects.
What evidence suggests that PD-L1 t-haNK could be an effective treatment for advanced cancer?
Research has shown that PD-L1 t-haNK cells, a type of immune cell, can help control tumor growth when combined with other treatments. These cells target cancer by recognizing a protein called PD-L1, which some cancers use to evade the immune system. Studies have found that using PD-L1 t-haNK cells with other immune therapies can effectively slow cancer spread. Importantly, early trials demonstrated that PD-L1 t-haNK treatment is safe, as no severe side effects were observed in a small group of patients with advanced cancers. This trial studies different dose levels of PD-L1 t-haNK for their potential effectiveness against various solid tumors.12367
Are You a Good Fit for This Trial?
Adults with advanced or metastatic solid cancers who've had at least one prior treatment can join this trial. They need a measurable tumor, must provide a recent biopsy, and be able to follow the study's schedule. People with autoimmune diseases, organ transplants, severe heart conditions, uncontrolled hypertension, certain infections like HIV or inadequate organ function are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of PD-L1 t-haNK to determine the maximum tolerated dose
Dose Expansion
Participants receive the recommended phase 2 dose of PD-L1 t-haNK to assess safety and preliminary efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PD-L1 t-haNK
Trial Overview
The trial is testing PD-L1 t-haNK for safety and early signs of effectiveness in treating various solid tumors. It aims to find the highest dose patients can tolerate without serious side effects and recommend a dose for future studies.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level 2 is 3 to 6.
PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level -1a is 3 to six, if needed.
PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into RP2D is 4.
PD-L1 t-haNK will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level 1 is 3 to 6.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ImmunityBio, Inc.
Lead Sponsor
Richard Adcock
ImmunityBio, Inc.
Chief Executive Officer since 2024
Information not available
Dr. Patrick Soon-Shiong
ImmunityBio, Inc.
Chief Medical Officer since 2021
MD
Citations
PD-L1 targeting high-affinity NK (t-haNK) cells induce ...
PD-L1 t-haNK cells in combination with anti-PD-1 antibody and N-803 resulted in improved tumor growth control. Other studies have reported that ...
CAR-T and CAR-NK as cellular cancer immunotherapy for ...
Both CAR-T and CAR-NK cells have shown consistent and promising results in hematological malignancies. However, their efficacy against solid ...
NantKwest Announces Phase 1 Results for First-in-Human ...
First-in-human trial shows no dose-limiting toxicities in six subjects treated as out-patients with PD-L1.t-haNK off-the-shelf CAR NK cell therapy.
PD-L1 blockade enhances anti-tumor efficacy of NK cells - PMC
Anti-PD-1/anti-PD-L1 therapies have shown success in cancer treatment but responses are limited to ~ 15% of patients with lymphocyte infiltrated, PD-L1 positive ...
Emerging combined CAR-NK cell therapies in cancer ...
Thus, it appears that combining CAR-NK cells and PD-1 and/or PD-L1 inhibitors holds promise for treating metastatic tumors.26. Activated NK ...
The clinical landscape of CAR NK cells
Here we explore the current clinical landscape of CAR NK cells, and their application in hematologic malignancies and solid cancers.
Precision sniper for solid tumors: CAR-NK cell therapy - PMC
However, the therapeutic efficacy of CAR-T cells against solid tumors remains suboptimal, accompanied by toxic side effects such as cytokine ...
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