Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377228
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-17
Brief Title:
A Study of TAK-007 in Adults With Refractory Lupus Nephritis LN
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 1b Open-Label Multicenter Study to Evaluate the Safety and Efficacy of TAK-007 an Allogeneic Anti-CD19 Chimeric Antigen Receptor Natural Killer Cell CD19 CAR-NK Therapy in Adult Subjects With Refractory Lupus Nephritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The main aim of the study is to learn how well adults with refractory lupus nephritis LN tolerate TAK-007 and to check for side effects adverse events
Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN what effects TAK-007 has on the human body and whether participants will produce antibodies against TAK-007
Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN what effects TAK-007 has on the human body and whether participants will produce antibodies against TAK-007
Detailed Description:
The drug being tested in this study is called TAK-007 TAK-007 is being tested to treat people with refractory LN This study will look at the safety and tolerability of TAK-007
The study will enroll approximately 20 patients Participants will receive a single dose of TAK-007 which is an anti-CD19 chimeric antigen receptor natural killer cell CD19 CAR-NK therapy
Participants will be treated with 3 days of intravenous IV lymphodepleting chemotherapy LDC and then after a gap of at least 2 days a single IV dose of TAK-007 on Day 1
This multi-center trial will be conducted in the United States The overall time to participate in this study is approximately 24 months
The study will enroll approximately 20 patients Participants will receive a single dose of TAK-007 which is an anti-CD19 chimeric antigen receptor natural killer cell CD19 CAR-NK therapy
Participants will be treated with 3 days of intravenous IV lymphodepleting chemotherapy LDC and then after a gap of at least 2 days a single IV dose of TAK-007 on Day 1
This multi-center trial will be conducted in the United States The overall time to participate in this study is approximately 24 months
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