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Monoclonal Antibodies

TAK-007- 800 × 10^6 CD19-CAR+ Viable NK Cells for Lupus Kidney Disease

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My lupus is moderately to severely active.

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I have a specific type of kidney inflammation diagnosed by a biopsy.

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I tested positive for ANA and have either anti-dsDNA or anti-Smith antibodies.

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I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Dose Limiting Toxicities (DLTs)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Secondary outcome measures

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007

Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels

Change From Baseline in Antinuclear Antibody (ANA) Levels

+23 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,206 Previous Clinical Trials

4,188,049 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,215 Previous Clinical Trials

499,594 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I inquire about the criteria for potential participation in this medical study?

"To qualify for participation in this clinical study, individuals must present with lupus nephritis and be between 18 and 75 years old. The trial aims to recruit a total of 20 eligible participants."

Answered by AI

Are patients currently being enrolled in this research study?

"Information available on clinicaltrials.gov shows that patient recruitment is not ongoing for this particular study. The trial was first listed on 11/1/2024 and last revised on 4/17/2024. Although enrollment is closed, there are presently 56 other trials actively seeking participants."

Answered by AI

Is the trial allowing participants who have surpassed their second decade of life?

"Recruitment for this research study targets individuals aged above 18 years and below 75 years."

Answered by AI

What are the risks associated with TAK-007- 800 × 10^6 CD19-CAR+ Viable NK Cells for individuals?

"Given that this is a Phase 1 trial with restricted safety and efficacy data, our assessment at Power scores the safety of TAK-007 - 800 × 10^6 CD19-CAR+ Viable NK Cells as a 1 on the scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN)

2024. "A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06377228.

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