drugset / Trial / NCT06377228
A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or Refractory Systemic Sclerosis (SSc)
Non-randomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-06-13
- Primary completion
- 2030-09-02
- Completion
- 2030-09-02
Outcome
Outcome not reported
Stopped (Business): “Business decision (no safety concerns)”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SITOCABNAGENE LOXIVELEUCEL | Unknown | 8e+08 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |