mRNA-LNP Immunotherapy for Cancer

(mRNA-LNP Trial)

Overseen By Lijun Lijun, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: IntraAb, Inc.

Must not be taking: Autoimmune therapy

Disqualifiers: Autoimmune, Infection, Cardiovascular, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

PMC2129G12 is an investigational intratumorally administered messenger RNA-lipid nanoparticle (mRNA-LNP) immunotherapy designed to enable localized, transient expression of a humanized EpCAM-targeted CD3-engaging bispecific antibody together with the immunostimulatory cytokines to kill tumors by recruited immune T cells.

Who Is on the Research Team?

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

Exclusion Criteria

Pregnancy or breastfeeding

I have received treatment targeting EpCAM or CD3.

Active autoimmune disease requiring systemic therapy

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?

Group I: all participants Experimental Treatment 1 Intervention

mRNA-LNP

Who Is Running the Clinical Trial?

IntraAb, Inc.

Lead Sponsor