Lupus Nephritis - WHO Class IIIPhase 1NCT06265220
AB-101 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
A Phase 1 study testing AB-101, Cyclophosphamide and Fludarabine in people with Lupus Nephritis - WHO Class III and Lupus Nephritis - WHO Class IV, run by Artiva Biotherapeutics, Inc. at 9 sites in United States.
Trial summary
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus
- What is being tested?
- AB-101, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Apr 2024to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects with lupus nephritis Class III or IV (with or without the presence of Class V)
- Evidence of active disease on renal biopsy.
- All subjects are required to receive adequate concomitant antihypertensive and antiproteinuric therapy with blockade of the renin-angiotensin system
- Total systemic lupus erythematosus disease activity index (SLEDAI-2K score) ≥ 8, and clinical SLEDAI-2K ≥ 4.
- British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥ 1 organ, or a BILAG-2004 activity score of B in ≥ 2 organs.
- Subjects have failed at least two conventional therapies
Who cannot join
- Known past or current malignancy
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE
- Subjects with known active viral infections
- Severe active CNS Lupus
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Artiva Investigational Site Aventura
Aventura, Florida, 33180
Artiva Investigational Site Birmingham
Birmingham, Alabama, 35249
Artiva Investigational Site Charlotte
Charlotte, North Carolina, 28625
Artiva Investigational Site Iowa
Iowa City, Iowa, 52242
Artiva Investigational Site Mesquite
Mesquite, Texas, 75150
Artiva Investigational Site Plantation
Plantation, Florida, 33324
Artiva Investigational Site San Diego
San Diego, California, 92121
Artiva Investigational Site Woodlands
The Woodlands, Texas, 77382
Artiva Investigational Site Tucson
Tucson, Arizona, 85724
About this study
Official title: 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
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.
This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus.
Read more
The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus.
Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.
Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.
- Conditions
- Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, SLE
- Being tested
- AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab
- Keywords
- SLE, Lupus, Lupus Nephritis, AlloNK
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-101Drug
NK Cell Therapy
CyclophosphamideDrug
Lymphodepleting chemotherapy
FludarabineDrug
Lymphodepleting chemotherapy
RituximabDrug
Anti-CD20 antibody therapy
ObinutuzumabDrug
Anti-CD20 antibody therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose confirmation of AB-101 as Monotherapy | Experimental | Not described Receives: Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine |
| Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination | Experimental | Not described Receives: Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Obinutuzumab |
| Phase 1: Dose confirmation of AB-101 plus Rituximab combination | Experimental | Not described Receives: Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Incidence, severity and causality of adverse events and serious adverse events
Measured: From the time of consent through 104 weeks after initiation of study treatment
AB-101 Clinical Activity
Determined by Overall Response Rate in subjects with lupus nephritis and refractory systemic lupus erythematosus
Measured: From the time of first dose through 104 weeks after initiation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start3 Apr 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis - WHO Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artiva Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Saddekni, M.D., PgDip, BCMAS, Study director, Artiva Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265220
- Sponsor's protocol ID
- AB-101-03
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: AlloNK is early in clinical development, next steps will be based on the progress of our data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06265220
- Acronym / sponsor ID
- AB-101-03
- Conditions
- Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, SLE
- Keywords
- SLE, Lupus, Lupus Nephritis, AlloNK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Artiva Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.
This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus.
The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus.
Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.
Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose confirmation of AB-101 as Monotherapy | Experimental | Drug: AB-101, Drug: Cyclophosphamide, Drug: Fludarabine |
| Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination | Experimental | Drug: AB-101, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Obinutuzumab |
| Phase 1: Dose confirmation of AB-101 plus Rituximab combination | Experimental | Drug: AB-101, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult subjects with lupus nephritis Class III or IV (with or without the presence of Class V)
- Evidence of active disease on renal biopsy.
- All subjects are required to receive adequate concomitant antihypertensive and antiproteinuric therapy with blockade of the renin-angiotensin system
- Total systemic lupus erythematosus disease activity index (SLEDAI-2K score) ≥ 8, and clinical SLEDAI-2K ≥ 4.
- British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥ 1 organ, or a BILAG-2004 activity score of B in ≥ 2 organs.
Key exclusion criteria (4 listed)
- Known past or current malignancy
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE
- Subjects with known active viral infections
- Severe active CNS Lupus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-101NK Cell Therapy | Drug | Phase 1: Dose confirmation of AB-101 as Monotherapy, Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination, Phase 1: Dose confirmation of AB-101 plus Rituximab combination |
| CyclophosphamideLymphodepleting chemotherapy | Drug | Phase 1: Dose confirmation of AB-101 as Monotherapy, Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination, Phase 1: Dose confirmation of AB-101 plus Rituximab combination |
| FludarabineLymphodepleting chemotherapy | Drug | Phase 1: Dose confirmation of AB-101 as Monotherapy, Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination, Phase 1: Dose confirmation of AB-101 plus Rituximab combination |
| RituximabAnti-CD20 antibody therapy | Drug | Phase 1: Dose confirmation of AB-101 plus Rituximab combination |
| ObinutuzumabAnti-CD20 antibody therapy | Drug | Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination |
Primary outcome
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: From the time of consent through 104 weeks after initiation of study treatment
Incidence, severity and causality of adverse events and serious adverse events
AB-101 Clinical Activity
Time frame: From the time of first dose through 104 weeks after initiation of study treatment
Determined by Overall Response Rate in subjects with lupus nephritis and refractory systemic lupus erythematosus
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. AlloNK is early in clinical development, next steps will be based on the progress of our data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Saddekni, M.D., PgDip, BCMAS study director
Artiva Biotherapeutics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB-101, Cyclophosphamide and Fludarabine in people with Lupus Nephritis - WHO Class III and Lupus Nephritis - WHO Class IV, run by Artiva Biotherapeutics, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events (time frame: From the time of consent through 104 weeks after initiation of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.