NCT05020015

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The product being tested in this study is called TAK-007. TAK-007 is being tested to evaluate the safety and tolerability in adult participants with r/r B-cell NHL. The study will include 2 parts: Part 1 (Dose escalation and dose expansion) and Part 2. In Part 1, dose escalation cohorts' participants will receive TAK-007 as follows: Part 1 dose escalation: * Part 1: Dose escalation: TAK-007 - 200×10\^6 CD19-CAR+ Viable NK (Natural Killer) Cells (±30%) * Part 1: Dose escalation: TAK-007 - 800×10\^6 CD19-CAR+ Viable NK Cells (±25%) In Part 1 dose expansion phase, separate expansion cohorts for LBCL and iNHL (Cohorts 1A \[LBCL 3L+\] and 2A \[iNHL 3L+\]) and two additional dose expansion cohorts with a multi-dose regimen will be added (i.e., Cohort 1B and 1C) to evaluate more than 1 doses of TAK-007 after a 3-day regimen of lymphodepleting chemotherapy. Part 1 dose expansion cohorts' participants will receive TAK-007 as follows: * Part 1: Dose expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10\^6 CD19-CAR+ Viable NK Cells on Day 0 of the study. * Part 1: Dose expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10\^6 CD19-CAR+ Viable NK Cells on Day 0 of the study. Based on the data in Part 1, a single TAK-007 dose level will be selected by the sponsor and investigators as the recommended phase 2 dose (RP2D). Once RP2D is determined, participants will be enrolled in Part 2 of the study in the following cohorts: * Cohort 1: TAK-007 (LBCL) * Cohort 2: TAK-007 (iNHL) This multi-center trial will be conducted worldwide. Part 1 of the study will be conducted in the US, and Part 2 will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic and will enroll in a separate, long-term, follow-up study for continued safety assessments for up to 15 years after TAK-007 administration.

Conditions

• Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Interventions

Type	Name	Description
BIOLOGICAL	TAK-007	TAK-007 intravenous injection.
DRUG	Chemotherapy Agents	Fludarabine and cyclophosphamide as per standard of care.

Timeline

• Start date: 2021-11-12
• Primary completion: 2024-06-16
• Completion: 2038-12-20
• First posted: 2021-08-25
• Last updated: 2026-03-31
• Results posted: 2025-08-12

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study