ALLO-329 Therapy for Autoimmune Diseases

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

Recruiting Phase 1 Interventional Study
Systemic Lupus Erythematosus (With and Without Nephritis) Idiopathic Inflammatory Myopathy Systemic Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 74
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
Allogene Therapeutics · Industry
Who this trial is looking for

This trial is looking for adults with certain autoimmune diseases, including systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), or systemic sclerosis (SSc). Participants will receive a new therapy called ALLO-329 and will be closely monitored for safety and effectiveness.

Are You a Good Fit for This Trial?
Rules you out Systemic sclerosis with severe gastrointestinal issuesPulmonary arterial hypertensionActive central nervous system disease related to SLE

You may be able to join if

  • I am between 18 and 75 years old.
  • I have been diagnosed with an autoimmune disease.
  • I have had active disease despite standard treatments for at least 3 months.
  • I have signed an informed consent form.
  • I can comply with treatment and follow-up visits.
  • I have good blood and organ function.
  • I am willing to use contraception if I can become pregnant.

You may not be able to join if

  • I have an active infection that needs treatment.
  • I have had cancer in the last 5 years, unless it's low-risk skin cancer.
  • I have received certain cancer therapies before.
  • I have uncontrolled or serious health problems.
  • I have a serious heart condition that needs treatment.
  • I have liver cirrhosis that is not well-managed.
  • I have had significant lung issues or embolism recently.
  • I don’t want to participate in ongoing safety checks.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Adults ≥ 18 to \< 75 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…
Contacts

Allogene Therapeutics, Inc.

+1 415-604-5696

clinicaltrials@allogene.com

CONTACT