TAK-007 for Lupus Nephritis

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how adults with hard-to-treat lupus nephritis (a type of kidney inflammation) or systemic sclerosis (a disease causing skin and organ tightening) respond to a new treatment called TAK-007 and to monitor any side effects. Researchers also seek to determine TAK-007's effectiveness in treating these conditions and whether it prompts the body to produce certain antibodies. Suitable candidates have lupus nephritis or systemic sclerosis that has not improved with other treatments, such as common medications or biologics, and experience symptoms affecting their daily life. As a Phase 1 trial, this research focuses on understanding TAK-007's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have had an inadequate response to standard treatments, which suggests that some current medications might be continued. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that TAK-007 remains in the early stages of testing, meaning limited information exists about its safety for people. In its Phase 1 trial, researchers primarily assess how well individuals with hard-to-treat lupus nephritis (LN) and systemic sclerosis (SSc) tolerate the treatment.

Phase 1 trials mark the initial step in testing new treatments in humans, with a strong focus on safety. At this stage, the treatment has not been proven safe for large groups. Participants in the trial will help researchers learn about possible side effects and how the body responds to TAK-007. This phase is crucial for understanding the treatment's overall safety and potential. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Lupus Nephritis, which typically include immunosuppressive drugs like corticosteroids and cyclophosphamide, TAK-007 is unique because it utilizes genetically engineered natural killer (NK) cells. These cells are modified to specifically target and destroy CD19-positive cells, a type of immune cell that can contribute to lupus symptoms. Researchers are excited about TAK-007 because it offers a targeted approach, potentially leading to fewer side effects and more effective disease control. Additionally, the use of a single infusion of modified NK cells could mean faster results compared to traditional therapies that require prolonged use.

What evidence suggests that TAK-007 might be an effective treatment for lupus nephritis and systemic sclerosis?

Research suggests that TAK-007 might work by using special immune cells called CAR-NK cells, which are designed to find and destroy specific harmful cells in the body. Early studies of other treatments have shown that CAR-NK cells can fight diseases with fewer side effects than some other treatments. In this trial, participants with lupus nephritis will receive a single dose of TAK-007, while those with systemic sclerosis will receive either a single or multiple doses. Although specific data on TAK-007's success in treating lupus nephritis or systemic sclerosis is not yet available, this approach has shown promise in similar conditions. The treatment is still being tested to determine its effectiveness and safety for patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06377228

A Study of TAK-007 in Adults With Refractory Lupus ... 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 ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-of-tak-007-in-adults-with-refractory-lupus-nephritis-ln

A Study of TAK-007 in Adults With Refractory Lupus Nephritis ... TAK-007 is being tested to treat people with refractory LN or refractory SSc. This trial will look at the safety and tolerability of TAK-007.

3. withpower.com withpower.com/trial/phase-1-nephritis-10-2024-eba53

TAK-007 for Lupus Nephritis · Info for Participants 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 ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-tak-007-adults-refractory-lupus-nephritis-ln-trial-nct06377228

A Phase 1 Study of TAK-007 in Refractory Lupus Nephritis A Study to Test the Safety and Effectiveness of a New Treatment (TAK-007) for Adults with Lupus Nephritis that has not Responded to Other Treatments · Study ...

5. trials.arthritis.org trials.arthritis.org/trials/NCT06377228

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

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06377228/

Trial | NCT06377228 TAK-007 is being tested to treat people with refractory LN or refractory SSc. This trial will look at the safety and tolerability of TAK-007. The trial will ...