Senesco Technologies, Inc. ("Senesco" or the "Company") (OTC QB: SNTI) reported today that it has completed cohort 2 in its Phase 1b/2a clinical study of SNS01-T.
“We are pleased to have completed the second cohort in our Phase 1b/2a study”
In cohort 2, two multiple myeloma patients and one diffuse large B-cell lymphoma patient have completed the study. The safety data for the group will be provided to the Data Review Committee (DRC), who will meet and advise Senesco whether it is appropriate to proceed with cohort 3 and escalate the dose level to 0.2 mg/kg, a four-fold increase.
"We are pleased to have completed the second cohort in our Phase 1b/2a study," stated Leslie J. Browne, Ph.D., President and Chief Executive Officer of Senesco. "As soon as the DRC gives the go ahead, we expect to initiate cohort 3 and increase the dose level to 0.2 mg/kg."
The study is an open-label, multiple-dose, dose-escalation study, which will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL) patients. While the primary objective of this study is to evaluate safety and tolerability, the effect of SNS01-T on tumor response and time to relapse or progression will be assessed using multiple well-established metrics including measurement of monoclonal protein in multiple myeloma and CT imaging in MCL and DLBCL.
In the study, patients are dosed twice-weekly for 6 weeks followed by an observation period. The first group of patients received 0.0125 mg/kg per dose by intravenous infusion. The second group received 0.05 mg/kg and the planned dose levels for the third and fourth groups are 0.2 and 0.375 mg/kg, respectively. The top dose planned is 30 fold higher than the starting dose in cohort 1.
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