ALLO-329 for Lupus

(RESOLUTION Trial)

Recruiting at 1 trial location

Overseen By Allogene Therapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Allogene Therapeutics

Must be taking: Immunosuppressive agents, Hydroxychloroquine

Must not be taking: CD19 therapy, CD70 therapy

Disqualifiers: Active infection, Malignancy, Uncontrolled disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 60 months

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and initial effects of ALLO-329, a new therapy for individuals with certain autoimmune diseases such as lupus, inflammatory muscle diseases, or scleroderma (a condition causing skin thickening). Participants will receive ALLO-329 either with or without a drug that prepares the body to accept the treatment. This trial suits those with active disease who have not responded to other treatments and are willing to follow the study's schedule. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the ALLO-329 trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have disease activity despite prior treatment with standard therapy, including at least one immunosuppressive agent and hydroxychloroquine. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that ALLO-329 is likely to be safe for humans?

Research shows that ALLO-329 is a new treatment known as CAR T-cell therapy, which targets specific proteins on immune cells. Scientists have studied this treatment in labs to understand its effects on the immune system. ALLO-329 has been found to reduce certain immune cells that may contribute to autoimmune diseases.

As this is the first human trial of ALLO-329, information about its safety is limited. However, the FDA has granted it fast track designation, indicating promise for safety and effectiveness, though further research is necessary.

In this trial, some participants will receive ALLO-329 following a drug called cyclophosphamide. Cyclophosphamide helps the body better accept the CAR T-cell therapy but can sometimes cause side effects like nausea or low blood counts.

Overall, while ALLO-329 appears promising, its safety in humans remains under study. Participants in this trial will help researchers determine how well the treatment is tolerated and identify potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Researchers are excited about ALLO-329 as a potential treatment for lupus because it offers a novel approach compared to traditional therapies like corticosteroids and immunosuppressants. ALLO-329 works by harnessing the body's immune system differently, potentially offering a more targeted and effective response against lupus. There are two distinct approaches under investigation: one utilizes ALLO-329 following a lymphodepletion regimen with cyclophosphamide, while the other administers ALLO-329 alone, aiming to minimize side effects and improve patient outcomes. This dual approach could provide more personalized treatment options for lupus patients, addressing both efficacy and safety concerns.

What evidence suggests that ALLO-329 might be an effective treatment for lupus?

Research suggests that ALLO-329 could be promising for treating autoimmune diseases like lupus. Early studies show that ALLO-329 effectively targets and destroys B cells, which are believed to contribute to these conditions. This trial will evaluate ALLO-329 in two treatment arms: one where participants receive ALLO-329 following a lymphodepletion regimen with cyclophosphamide, and another where participants receive ALLO-329 without lymphodepletion. This treatment uses CAR T cell therapy, a method designed to attack specific cells, and has shown the ability to reduce B cells and antibodies in lab tests. These initial findings indicate that ALLO-329 might offer benefits for people with lupus and similar autoimmune diseases. However, as this is a new treatment, more studies are needed to confirm its effectiveness and safety in humans. ^{1 6 7 8 9}

Who Is on the Research Team?

Allogene Study Director

Principal Investigator

Allogene Therapeutics, Inc.

Are You a Good Fit for This Trial?

Adults with autoimmune diseases like systemic lupus erythematosus, idiopathic inflammatory myopathy, and systemic sclerosis can join this trial. They must meet specific health criteria to be eligible.

Inclusion Criteria

Negative highly sensitive urine or serum pregnancy test for females of childbearing potential at screening

Willingness to use highly effective contraception for specified duration after LD chemotherapy or ALLO-329 administration

Signed and dated informed consent form

Exclusion Criteria

Unwillingness to participate in extended safety monitoring

Specific criteria for participants with SLE, IIM, or SSc as detailed

My liver disease is moderately to severely advanced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALLO-329, a dual anti-CD19/anti-CD70 allogeneic CAR T cell product, with or without a lymphodepletion regimen

Up to 60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• ALLO-329

Trial Overview The study is testing ALLO-329, an experimental CAR T-cell therapy combined with Cyclophosphamide, for safety and early signs of effectiveness in treating various autoimmune conditions.

How Is the Trial Designed?

Group I: ALLO-329, Cyclophosphamide Experimental Treatment 2 Interventions

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

Group II: ALLO-329 Experimental Treatment 1 Intervention

Participants receive ALLO-329 without a lymphodepletion regimen.

Who Is Running the Clinical Trial?

Allogene Therapeutics

Lead Sponsor

Trials

7

Recruited

810+

Headquarters

South San Francisco, USA

Known For

Allogenic CAR T

Top Products

Cemacabtagene ansegedleucel (cema-cel), ALLO-501, ALLO-501A, ALLO-316

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07085104

NCT07085104 | A Study to Investigate the Safety and ... This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults ...

2. lupus.org lupus.org/news/allogene-therapeutics-allo329-receives-fda-fast-track-designation-for-three-autoimmune

Allogene Therapeutics' ALLO-329 Receives FDA Fast ... The trial is designed to evaluate the safety and efficacy of ALLO-329 in people with SLE, IIM, and SSc. ... Phase III Study Shows Positive Results ...

3. ir.allogene.com ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-presents-preclinical-data-allo-329

Allogene Therapeutics Presents Preclinical Data for ALLO- ... B cell depletion and antibody reduction: ALLO-329 effectively eradicated B cells derived from healthy donors and patients with systemic lupus ...

4. cgtlive.com cgtlive.com/view/allogene-therapeutics-allo-329-cleared-fda-phase-1-clinical-trial-rheumatology-indications

Allogene Therapeutics' ALLO-329 Cleared by FDA for ... The study's efficacy findings covered 26 patients who had confirmed CD70-positive RCC and were evaluable as of the October 14, 2024 data cutoff.

5. acrabstracts.org acrabstracts.org/abstract/preclinical-evaluation-of-allo-329-allogeneic-cd19-car-t-cells-expressing-an-anti-rejection-cd70-car-for-the-treatment-of-autoimmune-diseases/

Preclinical Evaluation of ALLO-329: Allogeneic CD19 CAR ... Results: ALLO-329 exhibited cytotoxic activity and target-mediated expansion in the presence of tumor cell lines expressing CD19 and/or CD70. Primary CD19+ B ...

6. ir.allogene.com ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-secures-us-fda-ind-clearance-allo-329

Allogene Therapeutics Secures U.S. FDA IND Clearance ... The Phase 1 RESOLUTION basket trial will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, ...

7. lupusgreaterohio.org lupusgreaterohio.org/allogene-therapeutics-allo-329-receives-fda-fast-track-designation-for-three-autoimmune-conditions-including-active-refractory-moderate-to-severe-systemic-lupus-erythematosus/

Allogene Therapeutics' ALLO-329 Receives FDA Fast ... Allogene Therapeutics' ALLO-329 Receives FDA Fast Track Designation for Three Autoimmune Conditions, Including Active Refractory Moderate-to- ...

8. crisprmedicinenews.com crisprmedicinenews.com/news/allogenes-dual-acting-car-t-candidate-allo-329-gets-fda-green-light-for-autoimmune-disease-trial/

Allogene's Dual-Acting CAR T Candidate ALLO-329 Gets ... In December, Allogene presented pre-clinical data for ALLO-329 demonstrating that it induces deep, transient depletion of CD19+ B Cells and ...

9. lupushub.com lupushub.com/medical-information/fda-grants-fast-track-designation-to-allo-329-for-the-treatment-of-systemic-lupus-erythematosus

FDA grants fast track designation to ALLO-329 for the ... On April 7, 2025, the US FDA granted fast track designation to ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T-cell product.