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).
Adults ≥ 18 to < 75 years of age.
Adequate hematological function and liver, cardiac, and pulmonary function.
A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months for females (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later.
Signed and dated informed consent form.
Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.
Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6) under observation. Prior treatment of cancer with curative intent which in the opinion of the treating oncologist has less than a 10% chance of recurrence in the next 10 years can be allowed after discussion with the sponsor.
Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study.
Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes).
Sequential
ALLO-329
GeneticAn allogeneic CAR T cell therapy targeting CD19 and CD70
Cyclophosphamide
DrugChemotherapy for lymphodepletion
Fludarabine
DrugChemotherapy for lymphodepletion
Incidence 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)
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by rates of achieving SRI-4, LLDAS and DORIS remission.
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by change from baseline in SLEDAI-2K score.
Disease Response to Treatment - Lupus Nephritis
Efficacy as assessed by complete renal response (CRR) and partial renal response (PRR).
Disease Response to Treatment - Idiopathic Inflammatory Myopathy
Efficacy as assessed by ACR/EULAR myositis response criteria components.
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