AB-101 + B-cell Depleting mAb for Lupus Nephritis

Phase 1

Recruiting

Research Sponsored by Artiva Biotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Adult subjects with biopsy proven lupus nephritis Class III or IV either with or without the presence of Class V according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, who failed or did not respond to previous standard of care treatment approaches

Eligible subjects must have evidence of active disease on renal biopsy based on the modified NIH Lupus Nephritis activity and chronicity indices

Must not have

Known past or current malignancy other than inclusion diagnosis

Known clinically significant cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of first dose through 104 weeks after initiation of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cell product called AB-101, which contains natural killer cells that can enhance the effect of antibody therapies. The trial will enroll adults with lupus nephritis who have not

Who is the study for?

This trial is for adults with Class III or IV lupus nephritis, a serious kidney condition caused by lupus, who haven't improved with standard treatments. Participants may also have Class V lupus nephritis. They must be able to receive the study medications and follow-up assessments.

What is being tested?

The trial tests AB-101 (AlloNK), an immune cell therapy designed to boost antibody treatments, in combination with rituximab after pre-treatment with cyclophosphamide and fludarabine. It aims to see if this combo is safe and effective for those whose lupus nephritis didn't respond to other therapies.

What are the potential side effects?

Potential side effects include reactions related to the immune system's enhancement such as fever, fatigue, infusion-related reactions from rituximab, and possible low blood counts due to chemotherapy agents like cyclophosphamide and fludarabine.

Eligibility Criteria

Inclusion Criteria

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

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I have lupus affecting my kidneys (Class III or IV) and standard treatments haven't worked.

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My kidney biopsy shows active lupus nephritis.

Exclusion Criteria

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

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I have or had cancer types other than the one I'm seeking treatment for.

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I have a known heart condition.

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I have a significant lung condition or currently use tobacco.

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I have never had a hepatitis B infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of consent through 104 weeks after initiation of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of consent through 104 weeks after initiation of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of consent through 104 weeks after initiation of study treatment for reporting.