A representative of the company developing the investigational CAR-T cell therapy noted that they hypothesize that the combination “has the potential to further enhance efficacy and provide patients with a chemotherapy-sparing, second-line treatment option.”
The first patient in a phase 1b clinical trial has received treatment with a combination of TT11, an autologous CD30 CAR-T cell therapy, and Opdivo (nivolumab), according to a press release from the CAR-T cell therapy’s manufacturer, Tessa Therapeutics.
The aim of the investigation is to determine if the combination of TT11 and Opdivo may serve as a possible second-line treatment option for patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
According to the Mayo Clinic, classical Hodgkin lymphoma is the most common type of this disease.
The plan for the phase 1b ACTION study is to enroll up to 14 patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma after first-line therapy. Patients enrolled onto the trial will be treated with a “sandwich” method, according to the release. They will first receive two cycles of Opdivo followed by treatment with a combination of the chemotherapies bendamustine and fludarabine. After this, patients will then receive a single infusion of TT11 followed by an additional two rounds of Opdivo.
The main goal of the ACTION trial is to see if this treatment regimen is safe and well tolerated. The investigators also plan to assess the effect on overall response rate (percentage of patients whose disease partially or completely responds to treatment) and progression-free survival (time from treatment to disease progression).
“The current standard of care for relapsed or refractory classical Hodgkin Lymphoma is associated with short-term toxicities and long-term morbidity, with particularly poor tolerability noted among elderly patients,” said Dr. Ivan Horak, chief medical officer and chief scientific officer of Tessa Therapeutics, in a press release. “TT11, Tessa’s CD30 CAR-T (cell) therapy, has demonstrated encouraging clinical results as monotherapy, and we believe the combination with (Opdivo) has the potential to further enhance efficacy and provide patients with a chemotherapy-sparing, second-line treatment option.”
Data from another trial investigating TT11 showed that among 14 patients, treatment with the CAR-T cell therapy led to a complete response rate of 57.1% and an overall response rate of 71.4%.
The first part of the trial is expected to be completed by December 2025, according to a filing of the study on ClinicalTrials.gov.
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