US-based immuno-oncology company Formula Pharmaceuticals has initiated a Phase I/IIa clinical trial of allogeneic, cytokine-induced killer (CIK), cell-based chimeric antigen receptor (CAR) cancer immunotherapy for acute lymphoblastic leukaemia (ALL).
The CIK CAR technology is currently being developed to activate functionality of T-cells and natural killer cells within one effector cell population obtained from healthy donor or cord blood.
Designed to enrol both paediatric and adult patients with relapsed or refractory ALL, the open-label, dose-escalating Phase I/IIa trial will assess the safety, pharmacokinetics (PK) and anti-tumour activity of the modified allogeneic CIK cells.
Formula Pharmaceuticals president and CEO Maurits Geerlings said: “This clinical trial is the first to evaluate non-virally transfected, allogeneic CIK CAR in patients with cancer and is designed to demonstrate important clinical proof-of-concept for our entire platform.”
Funded by non-profit scientific institution Fondazione Matilde Tettamanti, the trial is performed at the MBBM Foundation / San Gerardo Hospital in Monza and the Azienda Ospedaliera Papa Giovanni XXIII in Bergamo, Italy.
Fondazione Matilde Tettamanti scientific director professor Andrea Biondi said: “We are very proud to have led the CIK CAR programme from the bench to the clinic and look forward to demonstrating the therapeutic potential of this platform for patients with persistent unmet need.
“We look forward to expanding our close collaboration with Formula into additional haematologic cancer applications.”
Based on its allogeneic CIK CAR technology platform, Formula is developing CAR immunotherapies for different haematologic and solid tumour indications.
Image: Acute lymphoblastic leukaemia. Photo: courtesy of VashiDonsk/English Wikipedia.