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

Acepodia Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: IgG4 Related Disease

Treatments: Drug: Lymphodepleting chemotherapy; Drug: ACE1831

Study type: Interventional

Funder types: Industry

Identifiers

NCT07061938

ACE1831-201

Details and patient eligibility

About

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)

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• Active IgG4-RD flare at screening with IgG4-RD Responder Index at least 2, confirmed by symptoms, labs, and/or imaging.
• History of IgG4-RD involving at least 2 organs/sites, and current flare involves at least 1 organ/site (excluding lymph nodes) requiring treatment.
• Elevated serum IgG4 above the upper limit of normal at screening.
• Able to receive glucocorticoids for current flare and taper to 0 mg by Day -5.
• Contraception agreement per protocol from screening through 24 weeks after last ACE1831 dose (no LDC) or 12 months after last LDC dose (with LDC).
• For sites in China only: prior treatment failure to glucocorticoids and at least one immunosuppressive agent.

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

• Significant conditions that impair ability to receive study treatment or comply.
• Predominant fibrosis in affected organs.
• Active/latent infection that would interfere with therapy (including HBV, HCV, HIV, TB, syphilis) or significant recent infection per protocol.
• Known immunodeficiency state.
• NYHA class III/IV heart disease.
• Severe allergy/hypersensitivity to monoclonal antibodies or relevant study agents.
• Malignancy within 5 years (protocol exceptions apply).
• Recent investigational agent exposure.
• Recent B-cell depleting therapy (anti-CD20/anti-CD19) unless reconstitution per protocol.
• Live/attenuated vaccine within 2 months.
• Pregnant or breastfeeding.
• Inadequate organ function/blood counts per protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm trial

Experimental group

Description:

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

Treatment:

Drug: ACE1831

Drug: Lymphodepleting chemotherapy