mRNA-LNP Immunotherapy for Cancer

(mRNA-LNP Trial)

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Overseen ByLijun Lijun, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using mRNA-LNP, a type of immunotherapy, to help the body's immune system fight cancer cells directly at the tumor site. The goal is to determine if this approach can safely and effectively shrink tumors by recruiting immune T cells to attack them. The trial seeks participants with advanced or metastatic solid tumors that haven't responded to standard treatments and have a specific protein (EpCAM) in their tumor cells. Participants should have at least one tumor that can be easily injected with the treatment. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

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. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Studies have shown that mRNA-LNP treatments hold promise for cancer by helping the immune system attack tumors. Research indicates that these treatments can successfully boost the body's ability to target tumors.

Regarding safety, evidence is still emerging. Some studies suggest that patients generally handle mRNA-LNP therapies well. However, unknowns about long-term effects remain, which is common for new treatments in early trial stages. Patients often experience mild side effects like fever or tiredness, similar to those seen with other vaccines.

Overall, while the treatment appears promising, long-term safety data remains limited. Those interested in participating should discuss potential risks and benefits with their healthcare provider.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about mRNA-LNP immunotherapy for cancer because it uses a novel method to instruct the body’s own cells to fight cancer. Unlike traditional treatments like chemotherapy or radiation, which can also damage healthy cells, this therapy utilizes messenger RNA (mRNA) delivered via lipid nanoparticles (LNP) to specifically target cancer cells. This approach not only aims for higher precision in attacking cancer cells but also has the potential to stimulate a stronger immune response, potentially leading to more effective and personalized cancer treatment options.

What evidence suggests that this treatment might be an effective treatment for cancer?

Research has shown that mRNA-LNP treatments hold promise for cancer care. These therapies instruct cells to produce proteins that help the immune system target tumors. Studies have found that these treatments can enhance T-cell activity, which plays a crucial role in the body's defense against cancer. In animal studies, mRNA-LNP treatments have successfully shrunk tumors and slowed cancer growth. Researchers continue to work on improving the safety and effectiveness of these therapies. Overall, early evidence suggests that mRNA-LNP could become a powerful tool in the fight against cancer.12356

Who Is on the Research Team?

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Lijun Wu, MD

Principal Investigator

IntraAb, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that haven't responded to standard treatments. Their tumors must have a certain protein (EpCAM) and be accessible for direct injection. Participants need good overall health, working major organs, and a life expectancy of at least 3 months.

Inclusion Criteria

Life expectancy ≥3 months
My blood, liver, and kidney functions are normal.
Willingness to use effective contraception
See 5 more

Exclusion Criteria

Pregnancy or breastfeeding
I have received treatment targeting EpCAM or CD3.
Active autoimmune disease requiring systemic therapy
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intratumoral injections of PMC2129G12 to evaluate safety, tolerability, and preliminary efficacy

4 weeks
Weekly visits for intratumoral injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-LNP

Trial Overview

The study tests an experimental treatment called mRNA-LNP, injected directly into the tumor. This therapy aims to help the immune system attack cancer by making special proteins inside the tumor. The trial looks at safety and how well it works.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: all participantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

IntraAb, Inc.

Lead Sponsor

Citations

An mRNA lipid nanoparticle-incorporated nanofiber ...

Here we report an mRNA lipid nanoparticle (LNP)-incorporated NHC microgel matrix, termed LiNx, by incorporating LNPs loaded with mRNA encoding tumour antigens.

Lipid nanoparticle-based mRNA delivery systems for cancer ...

Here, we will discuss the progress of LNP-based mRNA delivery trends in cancer immunotherapy and evaluate their treatment efficacy. Fig. 3.

Delivering the next generation of cancer immunotherapies ...

RNA lipid nanoparticles have recently emerged as modular tools for immune stimulation. Here, we discuss advancements in RNA-based cancer immunotherapies and ...

Advances in mRNA LNP-Based Cancer Vaccines - PMC - NIH

This review points out the basic mechanisms of mRNA-LNP vaccines in cancer immunotherapy and recent approaches in mRNA vaccine design.

Recent advances in lipid nanoparticles for cancer vaccine ...

mRNA-LNP vaccines can increase tumor-specific T-cell priming by delivering antigen and promoting antigen presentation, whereas PD-1/PD-L1 blockade can prevent ...

Lipid nanoparticle-based mRNA vaccines: a new frontier in ...

Currently, various immunotherapies based on mRNAs have been applied in clinical trials, and results have confirmed the efficacy of a range of treatments against ...