drugset / Trial / NCT05020015

A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

NCT05020015 ↗

Phase 2 Active not recruiting 27 enrolled Takeda
Non-randomizedSequentialOpen-labelTreatment

Summary

This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL. Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.

Timeline

Start
2021-11-12
Primary completion
2024-06-16
Completion
2038-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject SITOCABNAGENE LOXIVELEUCEL Unknown 200 cells Intravenous
Subject SITOCABNAGENE LOXIVELEUCEL Unknown 800 cells Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous