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Cell Therapy

Phase 1: Dose confirmation of AB-101 plus Rituximab combination 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

My kidney biopsy shows active lupus nephritis.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AB-101 Clinical Activity

Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1: Dose confirmation of AB-101 plus Rituximab combinationExperimental Treatment4 Interventions

Group II: Phase 1: Dose confirmation of AB-101 as MonotherapyExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

Rituximab

1999

Completed Phase 4

~1880

AB-101

2018

Completed Early Phase 1

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Artiva Biotherapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

395 Total Patients Enrolled

Sudhir Borgonha, MDStudy DirectorArtiva Biotherapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for patient enrollment in this clinical trial?

"Affirmative, the details on clinicaltrials.gov specify that this investigation is presently seeking suitable participants. The trial was initially disclosed on February 24th, 2024, and its most recent update occurred on February 15th, 2024. Recruitment aims to enroll a total of 18 patients from a single designated site."

Answered by AI

Are medical researchers actively seeking participants for this clinical trial?

"Yes, the details on clinicaltrials.gov indicate that this trial is currently enrolling participants. The trial was first listed on February 24th, 2024 and was last revised on February 15th, 2024. A total of 18 individuals are sought for participation from a single site."

Answered by AI

Are individuals older than thirty years being considered for enrollment in this research investigation?

"Individuals aged 18 to 99 are eligible for participation in this research, as outlined in the inclusion criteria."

Answered by AI

What are the risks associated with Phase 1: Dose Verification of AB-101 when used as a standalone treatment for individuals?

"The safety evaluation for Phase 1: Dose verification of AB-101 as a standalone treatment is rated at level 1 by our team due to the preliminary nature of this trial, which has limited evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis

2024. "AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06265220.

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