At a glance
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A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
In Brief
A Phase 2 clinical trial evaluating TAK-007 and Chemotherapy Agents for Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL). Active but no longer recruiting, targeting 27 participants across 15 sites.
Detailed 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.
Study Details
Timeline
Interventions
TAK-007 intravenous injection.
Fludarabine and cyclophosphamide as per standard of care.