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A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease

Purpose

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).

Conditions

Systemic Lupus Erythematosus (With and Without Nephritis)
Idiopathic Inflammatory Myopathy
Systemic Sclerosis
Lupus Nephritis

Eligibility

Eligible Ages: Between 18 Years and 69 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Adults ≥ 18 to < 70 years of age. 2. Adequate hematological function and liver, cardiac, and pulmonary function. 3. 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 (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later. 4. Signed and dated informed consent form. 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures. 6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and/or laboratory testing. 7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months (in addition to hydroxychloroquine [HCQ]).

Exclusion Criteria

Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection. 2. Any active malignancy within 3 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). 3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy). 4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes) not due to SLE/IIM/SSc. 5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention. 6. Child-Pugh Class B or C cirrhosis. 7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of enrollment. 8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment. 9. Any form of primary, inherited immunodeficiency. 10. Unwilling to participate in an extended safety monitoring period. 11. For participants with SLE: Active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months or expected need for renal replacement therapy within the next 12 months, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and/or interstitial fibrosis. 12. Participants with IIM: A myositis other than IIM classification, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody. 13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ALLO-329, Cyclophosphamide	Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide.	Genetic: ALLO-329 An allogeneic CAR T cell therapy targeting CD19 and CD70 Drug: Cyclophophamide Chemotherapy for lymphodepletion
Experimental ALLO-329	Participants receive ALLO-329 without a lymphodepletion regimen.	Genetic: ALLO-329 An allogeneic CAR T cell therapy targeting CD19 and CD70 Drug: Cyclophophamide Chemotherapy for lymphodepletion

Recruiting Locations

Astera Cancer Care
East Brunswick 5097402, New Jersey 5101760 08816

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710

More Details

NCT ID: NCT07085104
Status: Recruiting
Sponsor: Allogene Therapeutics

Study Contact

Allogene Therapeutics, Inc.
+1 415-604-5696
clinicaltrials@allogene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.