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

Conditions

• IgG4 Related Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ACE1831 — DRUG
  ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
• Lymphodepleting chemotherapy — DRUG
  Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.

Study Details

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)

Key Dates

Start date

Jan 1, 2026

Status verified

Feb 2026

Primary completion

Jan 20, 2027

Completion

Jun 20, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single Arm trial
  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 Measure

Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs [ Time Frame: up to 72 weeks post last-ACE1831 dose ]

Central Contacts

• Acepodia Clinical Team
  415 366 7822
  [email protected]

Locations (2)

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