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ADI-001 for Lupus Nephritis

Phase 1

Recruiting

Research Sponsored by Adicet Bio, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance ≤ 2

Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019)

Must not have

Presence of severe liver disease, Child-Pugh class B or C

Presence of autoimmune diseases other than SLE as the main diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for lupus nephritis in multiple centers. It will involve different stages like screening, treatment, and follow-up to find the appropriate dose and assess its safety and effectiveness

Who is the study for?

This trial is for people with lupus nephritis, a type of kidney inflammation due to systemic lupus erythematosus. Participants must have an active disease confirmed by a biopsy within the last 6 months and significant protein in their urine. They should be able to perform daily activities with some limitations (ECOG ≤ 2).

What is being tested?

The study tests ADI-001, alongside Cyclophosphamide and Fludarabine, for safety and effectiveness in treating lupus nephritis. It's an early-stage trial that includes screening, lymphodepletion (reducing certain white blood cells), treatment administration, and follow-up.

What are the potential side effects?

Potential side effects may include those common to immunotherapy such as fatigue, fever, chills; Cyclophosphamide might cause nausea or hair loss; Fludarabine can lead to immune suppression increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I have been diagnosed with systemic lupus erythematosus according to the 2019 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver disease is severe.

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I have an autoimmune disease, but it's not lupus.

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I have or had severe brain or spinal cord problems.

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My kidney issues are not caused by lupus nephritis.

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I have not had gene or cell therapy treatments before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of treatment emergent and treatment related adverse events

The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ADI-001 Dose ExtensionExperimental Treatment3 Interventions

After dose level has been declared safe, additional patients can be enrolled at the declared safe dose to further investigate the safety profile of ADI-001.

Group II: ADI-001 Dose ExpansionExperimental Treatment3 Interventions

Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).

Group III: ADI-001 Dose EscalationExperimental Treatment3 Interventions

ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860