TAK-007 for Lupus Nephritis

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Takeda

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My lupus is moderately to severely active.

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

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

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

Exclusion Criteria

I have tested positive for hepatitis B.

I have had lupus caused by medication.

I have tested positive for hepatitis C.

Treatment Details

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.

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.