Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Takeda
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
