AB-101 treatment for patients with severe lupus nephritis and refractory systemic lupus erythematosus
A Phase 1 Study to Evaluate the Efficacy and Safety of AB-101, an Allogeneic Cord Blood- Derived NK-Cell Therapy in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus
PHASE1 · Artiva Biotherapeutics, Inc. · NCT06265220
This study is testing a new treatment called AB-101 for adults with severe lupus nephritis or hard-to-treat lupus to see if it helps them feel better after other treatments have failed.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Artiva Biotherapeutics, Inc. (industry) |
| Drugs / interventions | rituximab, obinutuzumab, cyclophosphamide, fludarabine |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT06265220 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of AB-101, an allogeneic NK cell therapy, in combination with B-cell depleting monoclonal antibodies for adult patients suffering from Class III or IV lupus nephritis or other forms of refractory systemic lupus erythematosus. Participants must have previously failed standard treatments and will receive either AB-101 alone or in combination with other therapies like cyclophosphamide and rituximab. The study aims to determine the tolerability and preliminary activity of this novel treatment approach.
Who should consider this trial
Good fit: Ideal candidates include adults with biopsy-proven Class III or IV lupus nephritis or refractory systemic lupus erythematosus who have failed previous treatments.
Not a fit: Patients with mild lupus nephritis or those who have not undergone prior standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with severe lupus nephritis and refractory systemic lupus erythematosus who have not responded to existing therapies.
How similar studies have performed: While the use of NK cell therapies is emerging, this specific combination approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Lupus Nephritis: * 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 * A kidney biopsy must be performed \< 24 weeks prior to the screening visit or during the screening period. * Eligible subjects must have evidence of active disease on renal biopsy based on the modified NIH Lupus Nephritis activity and chronicity indices. * Eligible subjects must have detectable anti-double stranded DNA antibody titers for enrollment. Inclusion Criteria for Refractory Systemic Lupus Erythematosus: * Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria * Total SLE Disease Activity Index (SELENA-SLEDAI score) \>8 sat screening * Failed at least 12 weeks of 2 conventional therapies for SLE Exclusion Criteria: * Known past or current malignancy other than protocol stipulated low grade cancers, or curable cancer in complete response for \>2 years * Known clinically significant cardiac disease * Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE * Subjects with known active viral infections or, if with a history of HBV or HCV infections, have a viral load above the institution's limit of quantitation
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States (RECRUITING)
- University of California, San Diego — San Diego, California, United States (RECRUITING)
Study contacts
- Study coordinator: AB-101-03 Study Team
- Email: AB-101-03StudyTeam@ArtivaBio.com
- Phone: 858-377-8306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus