drugset / Trial / NCT06377228

A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or Refractory Systemic Sclerosis (SSc)

NCT06377228 ↗

Phase 1 Withdrawn Takeda
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

EvaluationDrugModalityDoseRoute
Subject SITOCABNAGENE LOXIVELEUCEL Unknown 8e+08 cells Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous