TAK-007

Unassigned

New Medicines

Refractory or relapsing CD 19 positive B-lymphoid malignancies (ALL, CLL, NHL) following at least 2 lines of chemoimmunotherapy, targeted therapy and stem cell transplant

Information

Advanced therapy medicinal product (ATMP)
Takeda
Takeda

Development and Regulatory status

None
None
Phase II Clinical Trials
Feb 20 · A pivotal study of the CD19 CAR NK is planned in 2021.[4]

Category

Cord blood derived (allogeneic) CD19 CAR Natural Killer (NK) cells modified with retroviral vector to express IL-15. A CD19 CAR increases specificity for B-cell malignancies whilst IL-15 enhances proliferation and survival of CAR NK cells in vivo. [1]
There were 13,886 new cases of NHL in 2014-2016 average in the UK and 3789 cases of CLL in the same period. Around 3,800 people are diagnosed with CLL in the UK each year.[2]
Refractory or relapsing CD 19 positive B-lymphoid malignancies (ALL, CLL, NHL) following at least 2 lines of chemoimmunotherapy, targeted therapy and stem cell transplant
Intravenous infusion

Trial or other data

Feb 20 · Positive interim results from a PI/IIa trial (NCT03056339) of TAK-007 were published in the NEJM. Pts (5 with CLL and 6 with NHL) received a single dose of the CD19 CAR NK cells at 3 dose levels. Clinical response was reported in 8 (73%) of 11 pts with 7 showing complete responses (CR). These 7 pts showed no evidence of disease at a median follow-up of 13.8 months. TAK-007 was not associated with the severe cytokine release syndrome (CRS), neurotoxicity nor any other major toxicities. [1,3-5]