Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) Clinical Trial
Official title:
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
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.
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. The study will enroll approximately 265 participants. 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 1A (LBCL 3L+): TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells on Day 0 of the study. - Part 1: Dose expansion: Cohort 2A (iNHL 3L+): TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells on Day 0 of the study. - Part 1: Dose Expansion: Cohort 1B (LBCL 3L+): TAK-007- 800×10^6 CD19-CAR+ Viable NK Cells on Days 0, 7 and 14 of the study. - Part 1: Dose Expansion: Cohort 1C (LBCL 2L): TAK-007- 800×10^6 CD19-CAR+ Viable NK Cells on Days 0, 7 and 14 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. ;