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

Not Applicable

Not yet recruiting

• Conditions: IgG4 Related Disease
• Interventions: Drug: ACE1831; Drug: Lymphodepleting chemotherapy

• Registration Number: NCT07061938
• Lead Sponsor: Acepodia Biotech, Inc.

Brief 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)

Detailed Description

ACE1831-201 study is an Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease

Study Timeline

• Study First Submitted: 2025-05-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-08-01
• Primary Completion: 2027-01-20
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

To be eligible for this study, all of the following inclusion criteria must be met:

• Signed Informed Consent
• Male or female ≥ 18 to 75 years of age
• History of meeting the 2019 ACR/EULAR Classification Criteria for IgG4-RD
• Experiencing an IgG4-RD flare at screening with organ involvement
• Elevated IgG4 serum level
• Women of childbearing potential and all male subjects must agree to use at least 1 highly effective method of contraception to avoid pregnancy for 24 weeks after completion of ACE1831 or 1 year after the completion of LDC, whichever is later.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this trial.

• Any medical, psychological, familial, or sociological conditions, or substance abuse that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent.
• Known predominant fibrosis
• Presence of active recurrent, chronic infection requiring treatment , or latent infection (HBV, HCV, HIV, TB, syphilis)
• Known immunodeficiency state.
• Malignancy within 5 years with the exception of certain treated malignancies with no evidence of disease
• Inadequate hematologic and renal, hepatic and cardiac function
• Pregnant or lactating female

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm trial	ACE1831	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
Single Arm trial	Lymphodepleting chemotherapy	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

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of ACE1831 in subjects with IgG4-RD	up to 72 weeks post last-ACE1831 dose	* To assess the incidence of Adverse Events (AEs), \[AEs including Treatment Emergent AEs, Serious AEs (SAEs), AEs of Special Interests (AESIs), and dose limiting toxicities (DLTs)\] (unit: number of AEs); * To assess number of subjects with clinically significant changes in clinical laboratory tests from baseline (unit: number of subjects); * To assess number of subjects with clinically significant changes in physical examination results from baseline (unit: number of subjects); * To assess number of subjects with clinically significant changes in electrocardiograms (ECGs) results (combined assessment of PR, QRS, QT, and QTcF interval, and heart rate) from baseline (unit: number of subjects); * To assess number of subjects with clinically significant changes in vital signs (temperature, respiratory rate, heart rate, blood pressure, heart rate, and SaO2) from baseline (unit: number of subjects)

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of ACE1831 (primary efficacy)	24 weeks after last dose of ACE1831	• Proportion of subjects in complete remission 24 weeks after last dose of ACE1831
3.1 To assess the efficacy of ACE1831 (secondary efficacy): Proportion of subjects who experience sustained complete remission	up to 72 weeks post-last ACE1831 dose	Proportion of subjects who experience sustained complete remission 72 weeks after last dose of ACE1831
3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first flare	up to 72 weeks post-last ACE1831 dose	Time (days) from first dose of ACE1831 to first flare
3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage	up to 72 weeks post-last ACE1831 dose	Cumulative GC usage (milligrams) at 24 weeks after the last dose of ACE1831
3.4 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SF-12	up to 72 weeks post-last ACE1831 dose	Changes in Quality of Life Questionnaire (QOL) Short Form 12 (SF-12) total score
3.5 To assess the efficacy of ACE1831 (secondary efficacy): Changes in PGA	up to 72 weeks post-last ACE1831 dose	Changes in Physician's Global Assessment (PGA) of disease activity score (Visual Activity Score, scale range 0 -100)
3.6 To assess the efficacy of ACE1831 (secondary efficacy): Time to PGA = 0	up to 72 weeks post last-ACE1831 dose	Time (days) to PGA assessment score of 0
3.7 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SGA	up to 72 weeks post last-ACE1831 dose	Changes in Subject's Global Assessment (SGA) of disease activity score (Visual Activity Score, scale range 0 - 100)
3.8 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SSI	up to 72 weeks post last-ACE1831 dose	Changes in IgG4-RD symptom severity index (IgG4-RD-SSI) score
3.9 To assess the efficacy of ACE1831 (secondary efficacy): Changes in IgG4-RD RI	up to 72 weeks post last-ACE1831 dose	Changes in IgG4-RD Responder Index (IgG4-RD RI) score

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States