Investigators of an expanded clinical trial have administered an investigational CAR-T cell therapy to the first patient with blood cancer.
The first patient has received MB-106, an investigational CAR-T cell therapy, in a multicenter, early-phase clinical trial testing the safety and efficacy of the treatment in patients with relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia, according to the drug’s manufacturer, Mustang Bio.
“We are excited to broaden the evaluation of MB-106 with this multicenter clinical trial …. To date, the data from the initial, ongoing clinical trial at Fred Hutch continue to demonstrate a high rate of complete and durable responses,” study chair Dr. Mazyar Shadman, an associate professor and physician at Fred Hutch Cancer Center and University of Washington School of Medicine in Seattle, said in a company-issued press release. “In addition, MB-106 has shown potential to treat patients in an outpatient setting and provide another immunotherapy option for patients treated previously with CD19-directed CAR-T cell therapy.”
Previous findings from an interim analysis of 28 patients enrolled onto the phase 1/2 trial (at the time only conducted at Fred Hutch Cancer Center) demonstrated that treatment with the investigational CAR-T cell therapy elicited an overall response rate of 96%. An overall response rate is an endpoint in clinical trials that evaluates the percentage of patients whose disease partially or completely responds to treatment.
These results also showed that 12 patients achieved a complete response that lasted for more than one year. Of note, 10 of those complete responses are ongoing. Moreover, four patients have had a complete response last for more than 24 months and the longest complete response is at 33 months.
“Data presented at several prestigious medical meetings earlier this year from the initial, ongoing phase 1/2 clinical trial at Fred Hutch show that MB-106 continues to demonstrate high efficacy and a favorable safety profile across patients with a wide range of hematologic malignancies,” Dr. Manuel Litchman, Mustang Bio’s president and CEO, said in the release. “We look forward to providing updates on our multicenter MB-106 clinical trial as it progresses and anticipate reporting efficacy data in the fourth quarter of this year.”
In the expanded trial, investigators aim to enroll approximately 287 patients. According to a filing on ClinicalTrials.gov, there will be three separate treatment groups. The first group will comprise patients with aggressive B-cell non-Hodgkin lymphoma including, but not limited to, diffuse large B-cell lymphoma and mantle cell lymphoma. Patients with indolent non-Hodgkin lymphoma including follicular lymphoma will be enrolled onto the second treatment group. The final group will include patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
The main goal of the expanded phase 2 trial, according to the filing on ClinicalTrials.gov, is to evaluate the overall response rate at 24 months. The investigators will also review how the CAR-T cell therapy improves duration of response (time from treatment to disease progression or death in those whose disease responded to treatment), progression-free survival (time a patient survives without disease progression) and overall survival (time from treatment to death from any cause) results.
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