KUALA LUMPUR, Aug 18 (Bernama) -- Tessa Therapeutics Ltd (Tessa) has announced the dosing of the first patient in a Phase 1b clinical trial investigating TT11, in combination with Bristol Myers Squibb’s nivolumab as a potential second-line treatment for patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL).
According to a statement, TT11 is the company’s autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy.
“Initiation of this Phase 1b clinical trial marks an important milestone for our autologous CD30.CAR-T programme as we now have the opportunity to evaluate TT11 in combination with nivolumab as a potential second-line treatment for relapsed or refractory classical Hodgkin lymphoma,” said CTO and Acting CEO of Tessa Therapeutics, John Ng.
“We now welcome the opportunity to capitalise 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.”
The Phase 1b open-label trial will enroll up to 14 patients with CD30+ cHL with relapsed or refractory disease after front-line therapy combining PD-1 antibody and CAR-T therapy in a “sandwich” study design.
Patients will initially receive two cycles of nivolumab dosed at four-week intervals followed by lymphocyte depleting treatment with fludarabine/bendamustine chemotherapy. Patients will then receive a single infusion of TT11, followed by two additional cycles of nivolumab.
The primary endpoint of the trial is safety and tolerability of the combination regimen. Secondary endpoints will evaluate key efficacy indicators including overall response rate, duration of response, and progression-free survival.
Tessa Therapeutics is a clinical-stage biotechnology company developing next-generation cell therapies for the treatment of hematological cancers and solid tumours.
More details at www.tessacell.com.
-- BERNAMA
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