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NCT07061938 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease

A Phase 1 study of IgG4 Related Disease, sponsored by Acepodia Biotech.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
3
Study locations

NCT07061938: Recruiting Phase 1 study of IgG4 Related Disease, sponsored by Acepodia Biotech.

NCT07061938 is a Phase 1 study of IgG4 Related Disease that is actively recruiting participants, run by Acepodia Biotech. The registered enrollment target is 30 participants, below the 85-participant average among 4 other IgG4 Related Disease trials with a reported enrollment target (65% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07061938, a Phase 1 study of IgG4 Related Disease, is actively recruiting participants, sponsored by Acepodia Biotech.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
3
Study locations

Study Summary

ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Immunoglobulin G4 Related Disease (IgG4-RD)

Primary Outcome

Primary Outcome Measures: Safety and Tolerability of ACE1831. Adverse Events: Incidence of TEAEs, SAEs, AESIs, and DLTs. Clinical Laboratory Abnormalities: Number of subjects with clinically significant abnormalities in protocol-defined clinical laboratory assessments compared with baseline. Physical Examination Abnormalities: Number of subjects with clinically significant changes from baseline. ECG Abnormalities: Number of subjects with clinically significant ECG changes (PR, QRS, QT/QTcF, he

Conditions Studied

Interventions

  • DRUG Lymphodepleting chemotherapy
  • DRUG ACE1831

Study Locations (3)

Georgia

  • Emory University - Atlanta

Massachusetts

  • Massachusetts General Hospital - Boston

JP

  • Kanazawa Medical University Hospital - Kahoku-gun

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-01-01
Est. Completion 2027-06-20
Phase Phase 1
Acepodia Biotech

4 total trials

What NCT07061938 shows while recruiting

NCT07061938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 85-participant average among 4 other IgG4 Related Disease trials with a reported enrollment target (65% lower).

The record links to 1 condition, with IgG4 Related Disease appearing as the primary indexed condition, and to 2 interventions - of which Lymphodepleting chemotherapy is the first listed.

NCT07061938 reports a single indexed study location in Georgia, Massachusetts, JP.

Frequently Asked Questions

What is clinical trial NCT07061938 about?

NCT07061938 is a clinical study titled "Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease". ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Immunoglobulin G4 Related Disease (IgG4-RD)

What is the current status of trial NCT07061938?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-01-01. Estimated completion is 2027-06-20.

What conditions does trial NCT07061938 study?

This clinical trial studies the following conditions: IgG4 Related Disease.

What interventions are being tested in trial NCT07061938?

The interventions under investigation include: Lymphodepleting chemotherapy (DRUG), ACE1831 (DRUG).

Who is sponsoring clinical trial NCT07061938?

This trial is sponsored by Acepodia Biotech, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07061938 being conducted?

This trial has 3 study locations across Georgia, Massachusetts, JP. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for IgG4 Related Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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Source: ClinicalTrials.gov NCT07061938, the US trial registry maintained by the National Library of Medicine. NCT07061938 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.