A Phase 1 interventional study of ALLO-329 and Cyclophosphamide in Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy and Systemic Sclerosis, sponsored by Allogene Therapeutics. Recruiting at 18 sites in 2 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Allogene Therapeutics · Phase 1, Interventional, and Treatment
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).
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 66 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Allogene Therapeutics is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide.
Genetic: ALLO-329 · Drug: Cyclophosphamide
Participants receive ALLO-329 without a lymphodepletion regimen.
Genetic: ALLO-329
Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine.
Genetic: ALLO-329 · Drug: Cyclophosphamide · Drug: Fludarabine
An allogeneic CAR T cell therapy targeting CD19 and CD70
Chemotherapy for lymphodepletion
Chemotherapy 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)
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
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Cyclophosphamide · Fludarabine
Lupus Erythematosus, Systemic →
Allogene Therapeutics