Systemic Lupus Erythematosus (With and Without Nephritis)Phase 1RESOLUTIONNCT07085104
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
A Phase 1 study testing ALLO-329, Cyclophosphamide and Fludarabine in people with Systemic Lupus Erythematosus (With and Without Nephritis) and Idiopathic Inflammatory Myopathy, run by Allogene Therapeutics at 18 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- What is being tested?
- ALLO-329, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 13 Nov 2025to Oct 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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).
- 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.
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- Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing.
- 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: History or 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 prior to signing the informed consent form or expected need for renal replacement therapy within the next 12 months after dosing, 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 specified classification per exclusion criteria, 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.
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States17 sites, 16 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Melissa Griffith, MD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Maximillian Konig, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29605
Melissa Cunningham, MD
- Recruiting
Atrium Health Rheumatology-Southpark
Charlotte, North Carolina, 28211
Leslie Ranken, MD
- Recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
Michael Macklin, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Lisa Criscione-Schreiber, MD
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
Birju Bhatt, MD
- Recruiting
Prisma Health
Greenville, South Carolina, 29425
Cory McGee, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Hanna Zembrzuska, MD
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Vikas Majithia, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Paul Schmidt, MD
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Hisham Abdel-Azim, MD
- Recruiting
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
Don Stevens, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Margrit Wiesendanger, MD
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Vivek Nagaraja, MD
- Recruiting
LDS Hospital - lntermountain Health
Salt Lake City, Utah, 84143
Pankhuri Gupta, MD
- Active, not recruiting
New York Medical College
Valhalla, New York, 10595
Canada1 site, 1 recruiting
- Recruiting
Hôpital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Nicolas Richard, MD
About this study
Official title: A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease
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
- Being tested
- ALLO-329, Cyclophosphamide, Fludarabine
- 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
- Medical subject headings
- Lupus Erythematosus, Systemic, Myositis, Scleroderma, Systemic, Lupus Nephritis, Dermatomyositis, Scleroderma, Diffuse, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-329Genetic
An allogeneic CAR T cell therapy targeting CD19 and CD70
CyclophosphamideDrug
Chemotherapy for lymphodepletion
FludarabineDrug
Chemotherapy for lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| ALLO-329, Cyclophosphamide | Experimental | Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide. Receives: Genetic: ALLO-329; Drug: Cyclophosphamide |
| ALLO-329 | Experimental | Participants receive ALLO-329 without a lymphodepletion regimen. Receives: Genetic: ALLO-329 |
| ALLO-329, Cyclophosphamide, Fludarabine | Experimental | Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine. Receives: Genetic: ALLO-329; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 60 months
Secondary outcomes (8)
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by rates of achieving SRI-4, LLDAS and DORIS remission.
Measured: Up to 60 months
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by change from baseline in SLEDAI-2K score.
Measured: Up to 60 months
Disease Response to Treatment - Lupus Nephritis
Efficacy as assessed by complete renal response (CRR) and partial renal response (PRR).
Measured: Up to 60 months
Disease Response to Treatment - Idiopathic Inflammatory Myopathy
Efficacy as assessed by ACR/EULAR myositis response criteria components.
Measured: 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.
Measured: 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).
Measured: Up to 60 months
ALLO-329 Peak Expansion (Cmax)
Measured: Up to 60 months
ALLO-329 Persistence Over Time Including Area Under the Expansion Curve (AUC)
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start13 Nov 2025
- Primary completionFeb 2028 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (With and Without Nephritis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allogene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allogene Study Director, Study director, Allogene Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085104
- Sponsor's protocol ID
- ALLO-329-101
- Acronym
- RESOLUTION
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease
- ClinicalTrials.gov ID
- NCT07085104
- Acronym / sponsor ID
- RESOLUTION / ALLO-329-101
- Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- Keywords
- Systemic lupus erythematosus, SLE, Lupus nephritis, LN, Idiopathic inflammatory myopathy, IIM, Myositis, Dermatomyositis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Allogene TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALLO-329, Cyclophosphamide | Experimental | Genetic: ALLO-329, Drug: CyclophosphamideParticipants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide. |
| ALLO-329 | Experimental | Genetic: ALLO-329Participants receive ALLO-329 without a lymphodepletion regimen. |
| ALLO-329, Cyclophosphamide, Fludarabine | Experimental | Genetic: ALLO-329, Drug: Cyclophosphamide, Drug: FludarabineParticipants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
Key exclusion criteria (13 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLO-329An allogeneic CAR T cell therapy targeting CD19 and CD70 | Genetic | ALLO-329, ALLO-329, Cyclophosphamide, ALLO-329, Cyclophosphamide, Fludarabine |
| CyclophosphamideChemotherapy for lymphodepletion | Drug | ALLO-329, Cyclophosphamide, ALLO-329, Cyclophosphamide, Fludarabine |
| FludarabineChemotherapy for lymphodepletion | Drug | ALLO-329, Cyclophosphamide, Fludarabine |
Primary outcome
Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters
Time frame: Up to 60 months
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)
8 secondary outcomes
Disease Response to Treatment - Systemic Lupus Erythematosus
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Lupus Erythematosus
Time frame: Up to 60 months
Disease Response to Treatment - Lupus Nephritis
Time frame: Up to 60 months
Disease Response to Treatment - Idiopathic Inflammatory Myopathy
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Sclerosis
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Sclerosis
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allogene Study Director study director
Allogene Therapeutics, Inc.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALLO-329, Cyclophosphamide and Fludarabine in people with Systemic Lupus Erythematosus (With and Without Nephritis) and Idiopathic Inflammatory Myopathy, run by Allogene Therapeutics at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allogene Therapeutics, Inc. (+1 415-604-5696, clinicaltrials@allogene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.