Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265220
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-09
Brief Title:
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
Sponsor:
Artiva Biotherapeutics Inc
Organization:
Artiva Biotherapeutics Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eg rituximab obinutuzumab after cyclophosphamide and fludarabine in adult subjects with relapsedrefractory 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 eg 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
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 eg rituximab obinutuzumab after cyclophosphamide and fludarabine in adult subjects with relapsedrefractory 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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None