ACE1831 for Immunoglobulin-Related Disease

Overseen By Acepodia Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Acepodia Biotech, Inc.

Disqualifiers: Fibrosis, Infections, Immunodeficiency, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy called ACE1831 to determine its effectiveness for Immunoglobulin G4 Related Disease (IgG4-RD), a condition where the immune system attacks the body's tissues. The trial aims to identify the optimal dose of ACE1831 and its impact on the disease, particularly during flare-ups when symptoms worsen. Participants will receive the treatment either with or without a special preparation step called lymphodepletion, a type of chemotherapy. Individuals diagnosed with IgG4-RD and currently experiencing a flare-up with organ involvement may be suitable for this trial. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ACE1831 has promising safety results from earlier studies. In one study with five patients, no serious side effects or immune reactions related to ACE1831, such as severe inflammation, nerve problems, or issues with the immune system attacking the body, were reported. This indicates that the treatment was well-tolerated at the tested dose. These findings are encouraging for those considering participation in clinical trials involving ACE1831. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for immunoglobulin-related diseases focus on managing symptoms or suppressing the immune system. But ACE1831 works differently, offering a targeted approach by using a novel mechanism that potentially modifies the disease process itself. Researchers are particularly excited because ACE1831 is designed to adjust the immune response more precisely, which could lead to better outcomes with fewer side effects. Additionally, the treatment comes in various dosing levels, allowing for customization based on patient needs, further enhancing its potential effectiveness.

What evidence suggests that ACE1831 might be an effective treatment for IgG4-RD?

Research has shown that ACE1831 could help treat conditions like Immunoglobulin G4-Related Disease (IgG4-RD). In a small study, one out of five patients experienced complete symptom resolution. Additionally, symptoms stopped worsening in three out of five patients. This trial will test ACE1831 in a single arm, where participants will receive different doses of ACE1831, with or without lymphodepleting chemotherapy, depending on their cohort assignment. This treatment uses special T cells from healthy donors designed to target and fight the disease. So far, ACE1831 has not caused any serious side effects, which is a positive sign for its potential use. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with IgG4-Related Disease, a condition where the immune system attacks the body. Participants must meet specific health criteria not provided here.

Inclusion Criteria

Signed Informed Consent

Elevated IgG4 serum level

I am between 18 and 75 years old.

Exclusion Criteria

My condition is primarily characterized by fibrosis.

Pregnant or lactating female

I have an ongoing infection that needs treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ACE1831 in dose escalation cohorts with or without lymphodepletion conditioning

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACE1831
• Lymphodepleting chemotherapy

Trial Overview The study tests ACE1831, an experimental cell therapy derived from healthy donors, alongside lymphodepleting chemotherapy to see if they're safe and effective in treating IgG4-RD.

How Is the Trial Designed?

Group I: Single Arm trial Experimental Treatment 2 Interventions

The single, open label study arm includes 3 dose escalation cohorts: * Cohort 1: * Cohort 1a: Receives ACE1831 (Dose Level 1) with lymphodepletion conditioning (LDC) * Cohort 1b: Receives ACE1831 (Dose Level 1) without LDC. * Cohort 2: Receives ACE1831 (Dose Level 2) with or without LDC depending on assignment * Cohort 3: Receives ACE1831 (Dose Level 3) with or without LDC depending on assignment

Who Is Running the Clinical Trial?

Acepodia Biotech, Inc.

Lead Sponsor

Trials

3

Recruited

80+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07061938

NCT07061938 | Study to Assess Safety, Efficacy and ... Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease · Study Overview · Contacts and Locations.

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/7251/528600/A-Phase-1-Open-Label-Multicenter-Study-of

A Phase 1, Open-Label, Multicenter Study of Treatment with ... Preliminary data in 5 pts showed no DLTs, ACE1831-related SAEs, as well as no CRS, ICANS, or GvHD in single dose of 0.3B cells in 5 pts. Dose ...

3. rarediseaseadvisor.com rarediseaseadvisor.com/news/fda-clears-ind-application-ace1831-igg4-rd/

FDA Clears Investigational New Drug Application for ... The FDA has cleared Acepodia's Investigational New Drug application for ACE1831 to treat immunoglobulin G4-related disease (IgG4-RD).

4. prnewswire.com prnewswire.com/news-releases/acepodia-announces-preliminary-clinical-data-from-phase-1-clinical-trial-of-ace1831-first-ever-anti-cd20-antibody-conjugated-allogenic-gamma-delta-t-cell-therapy-for-non-hodgkins-lymphoma-302139302.html

Acepodia Announces Preliminary Clinical Data From ... One out of five patients demonstrated complete response (CR) and three out of five patients experienced disease stabilization (SD) with single ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/acepodia-preliminary-ace1831/

Acepodia reports preliminary results from ACE1831 Phase ... According to the preliminary data, one out of five patients achieved complete response (CR), and three experienced disease stabilisation (SD) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07061938?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(IgG4-related%20disease%20OR%20%22IgG4-RD%22%20OR%20%22%20IgG4-related%20sclerosing%20disease%22%20OR%20%22%20IgG4-related%20systemic%20disease%22%20OR%20%22%20Immunoglobulin%20G4-related%20sclerosing%20disease%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING))&rank=3

Study to Assess Safety, Efficacy and Persistence of ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...