RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Cyclophosphamide for Systemic Lupus Erythematosus (With and Without Nephritis)

Q: Is NCT07085104 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07085104?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07085104?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary how well it works 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 measure the whether it is safe and how hard side effects are to live with 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).

Official registry: https://clinicaltrials.gov/study/NCT07085104 · Allogene Therapeutics · enrollment listed as 66

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ALLO-329, Cyclophosphamide, or Fludarabine. The registry lists allocation as randomized. This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary how well it works 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 measure the whether it is safe and how hard side effects are to live with 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).

They plan to enroll about 66 people at 18 sites. Taking part typically means taking a study drug (or dummy pill), genetic testing or a gene-targeted therapy plus check-ins.

Official title (unrewritten)

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

Interventions: ALLO-329, Cyclophosphamide, Fludarabine

Primary outcome (registry wording): Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters

Who it is for (from inclusion criteria)

Ages 18 Years to 74 Years
Adults ≥ 18 to \< 75 years of age
Adequate hematological function and liver, cardiac, and pulmonary function
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 the registry excludes

Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection
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
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

Public study contact (from the registry)

Allogene Therapeutics, Inc.

+1 415-604-5696

clinicaltrials@allogene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

18 listed

Mayo Clinic — Phoenix, Arizona (recruiting)
Loma Linda University Medical Center — Loma Linda, California (recruiting)
University of Colorado Denver — Aurora, Colorado (recruiting)
Mayo Clinic — Jacksonville, Florida (recruiting)
The University of Chicago Medical Center — Chicago, Illinois (recruiting)
University of Iowa — Iowa City, Iowa (recruiting)
University of Kansas Medical Center — Kansas City, Kansas (recruiting)
Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky (recruiting)
Johns Hopkins Hospital — Baltimore, Maryland (recruiting)
Astera Cancer Care — East Brunswick, New Jersey (recruiting)
Icahn School of Medicine at Mount Sinai — New York, New York (recruiting)
New York Medical College — Valhalla, New York (active_not_recruiting)

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07085104 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07085104?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07085104?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary