This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
An allogeneic CAR T cell therapy targeting CD19 and CD70
Chemotherapy for lymphodepletion
Mayo Clinic
Phoenix, Arizona, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGNorton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
RECRUITINGAstera Cancer Care
East Brunswick, New Jersey, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGPrisma Health
Greenville, South Carolina, United States
RECRUITINGLDS Hospital - lntermountain Health
Salt Lake City, Utah, United States
RECRUITINGHôpital Maisonneuve Rosemont
Montreal, Quebec, Canada
RECRUITINGIncidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters
The incidence of dose limiting toxicities (DLTs) and other safety parameters (including but not limited to treatment emergent adverse events \[AEs\], serious adverse events \[SAEs\], and clinical laboratory abnormalities)
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by rates of achieving SRI-4, LLDAS and DORIS remission.
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by change from baseline in SLEDAI-2K score.
Time frame: Up to 60 months
Disease Response to Treatment - Lupus Nephritis
Efficacy as assessed by complete renal response (CRR) and partial renal response (PRR).
Time frame: Up to 60 months
Disease Response to Treatment - Idiopathic Inflammatory Myopathy
Efficacy as assessed by ACR/EULAR myositis response criteria components.
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Sclerosis
Efficacy as assessed by change from baseline in the European Scleroderma Trials and Research Group (EUSTAR) activity index.
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Sclerosis
Efficacy as assessed by change from baseline in the American College of Rheumatology Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS).
Time frame: Up to 60 months
ALLO-329 Peak Expansion (Cmax)
Time frame: Up to 60 months
ALLO-329 Persistence Over Time Including Area Under the Expansion Curve (AUC)
Time frame: Up to 60 months
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