ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）

Tongji Hospital

Status: Not yet enrolling

Conditions: System Lupus Erythematosus(SLE)

Treatments: Drug: Lymphodepleting chemotherapy; Drug: ACE1831

Study type: Interventional

Funder types: Other

Identifiers

NCT07314567

ACE1831-301

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 Relapsed/Refractory Systemic lupus erythematosus (SLE)

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female 18 to 60 years (inclusive)
• History of meeting the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria, or the 1997 ACR criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC)
• Presence of anti-dsDNA antibodies and/or anti-nuclear antibodies (ANA) and/or anti-Smith (anti-Sm) antibodies positive
• SLE is in the moderate to severe active phase with the SLEDAI-2000 score ≥ 8
• At least one British Isle Lupus Rating Group Index (BILAG-2004) Class A (severe manifestation) or two Class B (moderate manifestation) organ scores, or both
• Inadequate response to glucocorticoids and at least 2 of treatments used for at least 3 months
• Women of childbearing potential and their partners must agree to use at least 1 highly effective method of contraception throughout the study period and for 1 year after treatment
• Signed informed consent

Exclusion criteria

• Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR < 50 ml/min/1.73m²
• Central nervous system disease caused by SLE or other conditions
• Significant medical history that would pose a risk to the patients safety from the investigator's opinion, or patients medical condition could worsen during the study
• Malignancies within 5 years
• Presence of active, recurrent, chronic infection requiring treatment , or latent infection (HBV, HCV, HIV, TB, syphilis)
• Received any B-cell depletion biologic therapy
• Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Participant

Experimental group

Description:

The single, open label study arm includes 2 dose escalation cohorts: Cohort 1: Receives ACE1831 (Dose Level 1) with LDC depending on assignment Cohort 2: Receives ACE1831 (Dose Level 2) with LDC depending on assignment

Treatment:

Drug: ACE1831

Drug: Lymphodepleting chemotherapy