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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

No Placebo-Only Group

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for hepatitis B.

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I have had lupus caused by medication.

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I have tested positive for hepatitis C.

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met