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

NCT07085104 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ALLO-329-101
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 10

Brief Summary

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

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

Keywords

Systemic lupus erythematosus; SLE; Lupus nephritis; LN; Idiopathic inflammatory myopathy; IIM; Myositis; Dermatomyositis; Anti-synthetase syndrome; Systemic sclerosis; Scleroderma; SSc; Autoimmune disease; CAR T; Allogeneic CAR T; CD19; CD70; AlloCAR T™

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 60 months

Secondary Outcomes (8)

• Disease Response to Treatment - Systemic Lupus Erythematosus

  Up to 60 months

• Disease Response to Treatment - Systemic Lupus Erythematosus

  Up to 60 months

• Disease Response to Treatment - Lupus Nephritis

  Up to 60 months

• Disease Response to Treatment - Idiopathic Inflammatory Myopathy

  Up to 60 months

• Disease Response to Treatment - Systemic Sclerosis

  Up to 60 months

Study Arms (2)

ALLO-329, Cyclophosphamide

EXPERIMENTAL

Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide.

Genetic: ALLO-329; Drug: Cyclophophamide

ALLO-329

EXPERIMENTAL

Participants receive ALLO-329 without a lymphodepletion regimen.

Genetic: ALLO-329

Interventions

ALLO-329 GENETIC

An allogeneic CAR T cell therapy targeting CD19 and CD70

ALLO-329; ALLO-329, Cyclophosphamide

Cyclophophamide DRUG

Chemotherapy for lymphodepletion

ALLO-329, Cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 to \< 70 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 (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later.
• Signed and dated informed consent form.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
• Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and/or laboratory testing.
• 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 \[HCQ\]).

You may not qualify if:

• 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 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).
• Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy).
• Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes) not due to SLE/IIM/SSc.
• 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.
• Child-Pugh Class B or C cirrhosis.
• Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of enrollment.
• 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.
• Any form of primary, inherited immunodeficiency.
• Unwilling to participate in an extended safety monitoring period.
• 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.
• 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.
• Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.

Sponsors & Collaborators

• Allogene Therapeutics: lead

Study Sites (10)

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, 40207, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29605, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29425, United States

RECRUITING

LDS Hospital - lntermountain Health

Salt Lake City, Utah, 84143, United States

RECRUITING

Hôpital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Myositis; Scleroderma, Systemic; Lupus Nephritis; Dermatomyositis; Scleroderma, Diffuse; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Polymyositis

Study Officials

• Allogene Study Director

  Allogene Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Allogene Therapeutics, Inc.

CONTACT

+1 415-604-5696; clinicaltrials@allogene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 25, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); CA (1)