IN8bio announced the completion of enrollment in the Phase 1 study of INB-100 in leukemia patients and the initiation of patient enrollment in the Phase 2 clinical trial evaluating INB-400 in newly diagnosed glioblastoma multiforme, GBM. Phase 1 Clinical Trial of INB-100 in Leukemia: Enrollment in the dose escalation phase of the Phase 1 clinical trial of INB-100 is now closed. This clinical trial assesses the safety of allogeneic gamma-delta T cells from haploidentical related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following hematopoietic stem cell transplantation. The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease, relapse rate and OS. Phase 2 Clinical Trial of INB-400 in GBM: The Phase 2 clinical trial of INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in “Arm A” of the study. The primary endpoint of the study is 12-month overall survival rate, and key secondary endpoints include tolerability, progression-free survival, overall response rate and time to progression. The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.
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