NEW YORK – Tessa Therapeutics said on Wednesday that it has dosed the first lymphoma patient in a Phase Ib trial of its investigational CAR T-cell therapy TT11 plus Bristol Myers Squibb's Opdivo (nivolumab).
The trial, dubbed ACTION, is designed to evaluate the autologous CD30-directed CAR T-cell therapy plus the PD-1 inhibitor as second-line treatment for up to 14 patients with CD30-positive relapsed or refractory classical Hodgkin lymphoma after chemotherapy.
Singapore-based Tessa Therapeutics is calling the treatment regimen evaluated in the trial a "sandwich" design. Patients enrolled in the trial will receive two cycles of Opdivo followed by a lymphodepleting chemotherapy regimen, then a single infusion of the autologous TT11 CAR T-cell therapy, then another two cycles of Opdivo. The primary goal of the trial is to evaluate the treatment's safety and tolerability, and secondary aims include overall response rate, duration of response, and progression-free survival.
Tessa is also evaluating TT11 as a monotherapy for CD30-positive relapsed or refractory classical Hodgkin lymphoma in the Phase II CHARIOT trial. Initial data from that study showed that the cell therapy had a favorable safety profile and promising efficacy, with a 57.1 percent complete response rate and a 71.4 percent overall response rate among 14 patients. Tessa expects to begin the pivotal Phase II portion of that trial later this year.
"We welcome the opportunity to capitalize on this clinical progress by investigating TT11 as a second-line combination therapy, which offers the opportunity to greatly increase the patient population who could potentially benefit from this course of care," John Ng, chief technology officer and acting CEO of Tessa, said in a statement.
The firm believes that combining the CAR T-cell therapy with Opdivo will improve its efficacy and offer classical Hodgkin lymphoma patients a second-line treatment option that is more tolerable than chemotherapy. The US Food and Drug Administration has designated TT11 a regenerative medicine advanced therapy and the European Medicines Agency has designated it a priority medicine.