← Back to Search

Monoclonal Antibodies

TAK-007 for Lupus Nephritis

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has a SLEDAI-2K total score ≥6
Participant must have a histologically proven glomerulonephritis (proliferative LN class III or IV, with or without the presence of class V, according to 2018 ISN/RPS criteria)
Must not have
Participant is positive for hepatitis B surface antigen, hepatitis B virus (HBV) deoxyribonucleic acid (DNA), or hepatitis B core antibody
Participant has a history of drug-induced SLE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 24
Awards & highlights

Summary

This trial aims to see how well adults with a specific type of kidney inflammation called refractory lupus nephritis tolerate a drug called TAK-007 and to check for any side effects. It also

Who is the study for?
This trial is for adults with lupus nephritis that hasn't responded to standard treatments. Participants should have active kidney disease due to lupus and be able to attend regular study visits. Specific details on who can or cannot participate are not provided here.
What is being tested?
The study tests TAK-007, a potential new treatment for refractory lupus nephritis, alongside usual chemotherapy agents. It aims to assess the safety, effectiveness, and biological effects of TAK-007, including any immune response against it.
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to TAK-007 and typical chemotherapy-related issues such as nausea, fatigue, hair loss, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lupus is moderately to severely active.
Select...
I have a specific type of kidney inflammation diagnosed by a biopsy.
Select...
I tested positive for ANA and have either anti-dsDNA or anti-Smith antibodies.
Select...
I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have tested positive for hepatitis B.
Select...
I have had lupus caused by medication.
Select...
I have tested positive for hepatitis C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary study objectives
Change From Baseline in Physician's Global Assessment (PGA) Score
Duration of CRR
Duration of DORIS Remission
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TAK-007- 800 × 10^6 CD19-CAR+ Viable NK CellsExperimental Treatment2 Interventions
Participants will receive IV LDC, for 3 days in conditioning phase (Days -5, -4, and -3), followed by a single dose of IV 800 × 10\^6 TAK-007 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy Agents
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,227 Previous Clinical Trials
4,222,485 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,252 Previous Clinical Trials
504,359 Total Patients Enrolled
~13 spots leftby Apr 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top