TAK-007 for Lupus Nephritis

Recruiting at 3 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Disqualifiers: Neuropsychiatric lupus, Antiphospholipid syndrome, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

Trial Summary

What is the purpose of this trial?

The main aim of the trial is to learn how well adults with refractory lupus nephritis (LN) or refractory systemic sclerosis (SSc) 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 or refractory SSc, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007.

Research Team

Study Director

Principal Investigator

Takeda

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.

My lupus hasn't improved after trying at least 2 standard treatments or 1 biologic treatment.

Exclusion Criteria

I have tested positive for hepatitis B.

Participant has a history of human immunodeficiency virus (HIV) infection or has positive serology for HIV

I have had lupus caused by medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants receive 3 days of intravenous lymphodepleting chemotherapy (LDC)

1 week

3 visits (in-person)

Treatment

Participants receive TAK-007 therapy, either a single dose or multiple doses depending on cohort

3 weeks

3-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Chemotherapy Agents
• TAK-007

Trial Overview 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.

Participant Groups

Group I: SSc Cohort: Part 2 (Dose Expansion): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

Based on the data of Part 1, Part 2 may be initiated for participants with SSc to receive IV LDC, for 3 days in conditioning phase (Days -5, -4, and -3), followed by either single dose of IV 800 × 10\^6 TAK-007 on Day 1 or multiple doses of IV 800 × 10\^6 TAK-007 on Days 1, 8, and 15.

Group II: SSc Cohort: Part 1b: Multiple Dose TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

Participants with SSc will receive IV LDC, for 3 days in conditioning phase (Days -5, -4, and -3), followed by multiple doses of IV 800 × 10\^6 TAK-007 on Days 1, 8, and 15.

Group III: SSc Cohort: Part 1a: Single Dose TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

Participants with SSc 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.

Group IV: LN Cohort: Single Dose TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

Participants with LN 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 with a potential to explore an alternate dose level if deemed appropriate.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier