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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm trial | Experimental | The single, open label study arm includes 3 dose escalation cohorts:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE1831 | Drug | ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs | 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, heart rate) from baseline. Vital Signs Abnormalities: Number of subjects with clinically significant changes from baseline. Number of Subjects With Clinically Significant Changes in Vital Signs From Baseline. Number of subjects with clinically significant changes in vital signs, including temperature, respiratory rate, heart rate, blood pressure, and oxygen saturation (SpOâ‚‚), compared with baseline. For all of the above, Unit of Measure: Number of Subjects | up to 72 weeks post last-ACE1831 dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of ACE1831 (primary efficacy) | • Proportion of subjects in complete remission 24 weeks after last dose of ACE1831 | 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 |
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Inclusion Criteria: To be eligible for this study, all of the following inclusion criteria must be met:
Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Acepodia Clinical Team | Contact | 415 366 7822 | clinical@acepodiabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D000077733 | Immunoglobulin G4-Related Disease |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Lymphodepleting chemotherapy | Drug | Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration. |
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Proportion of subjects who experience sustained complete remission 72 weeks after last dose of ACE1831 |
| up to 72 weeks post-last ACE1831 dose |
| 3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first flare | Time (days) from first dose of ACE1831 to first flare | up to 72 weeks post-last ACE1831 dose |
| 3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage | Cumulative GC usage (milligrams) at 24 weeks after the last dose of ACE1831 | up to 72 weeks post-last ACE1831 dose |
| 3.4 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SF-12 | Changes in Quality of Life Questionnaire (QOL) Short Form 12 (SF-12) total score | up to 72 weeks post-last ACE1831 dose |
| 3.5 To assess the efficacy of ACE1831 (secondary efficacy): Changes in PGA | Changes in Physician's Global Assessment (PGA) of disease activity score (Visual Activity Score, scale range 0 -100) | up to 72 weeks post-last ACE1831 dose |
| 3.6 To assess the efficacy of ACE1831 (secondary efficacy): Time to PGA = 0 | Time (days) to PGA assessment score of 0 | up to 72 weeks post last-ACE1831 dose |
| 3.7 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SGA | Changes in Subject's Global Assessment (SGA) of disease activity score (Visual Activity Score, scale range 0 - 100) | up to 72 weeks post last-ACE1831 dose |
| 3.8 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SSI | Changes in IgG4-RD symptom severity index (IgG4-RD-SSI) score | up to 72 weeks post last-ACE1831 dose |
| 3.9 To assess the efficacy of ACE1831 (secondary efficacy): Changes in IgG4-RD RI | Changes in IgG4-RD Responder Index (IgG4-RD RI) score | up to 72 weeks post last-ACE1831 dose |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Kanazawa Medical University Hospital | Recruiting | Kahoku-gun | JP | 920-0293 | Japan |
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